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Study Results
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Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied
This study has been completed.
Study NCT00301262   Information provided by Pfizer
First Received: March 7, 2006   Last Updated: December 8, 2008   History of Changes
Study Type: Interventional
Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment
Condition: Impotence
Intervention: Drug: Viagra (Sildenafil citrate)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
31 centers in Canada

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
183 subjects entered the study, and 176 subjects were treated in the Double Blind (DB) phase. One subject completed DB phase and continued into the open-label (OL) phase but had no events of sexual activity and therefore, did not take study drug and was excluded from the number of treated subjects, the safety analysis set, and PP population.

Reporting Groups
  Description
DB Viagra / OL Viagra Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
DB Placebo/OL Viagra Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).

Participant Flow for 2 periods
Period:   Double Blind Phase (DB)
  DB Viagra / OL Viagra DB Placebo/OL Viagra
STARTED   94     82  
COMPLETED   84     69  
NOT COMPLETED   10     13  
      Adverse Event               1                 0  
      Lack of Efficacy               0                 1  
      Lost to Follow-up               3                 3  
      Withdrawal by Subject               5                 5  
      unknown               1                 4  

Period:   Open Label Phase (OL)
  DB Viagra / OL Viagra DB Placebo/OL Viagra
STARTED   83     69  
COMPLETED   79     67  
NOT COMPLETED   4     2  
      Adverse Event               1                 0  
      Lost to Follow-up               1                 2  
      unknown               2                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Start : DB Viagra Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks).
Start : DB Placebo Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).

Baseline Measures
  Start : DB Viagra Start : DB Placebo Total
Number of Participants  
[units: participants]
 		94 82 176
Age[1]
[units: years]
Mean ± Standard Deviation 		51.6 ± 12.5 48.0 ± 11.9 49.9 ± 12.3
Gender[2]
[units: participants]
 		     
Female 0 0 0
Male 94 82 176
[1] DB Viagra/OL Viagra=52.2+/-12.1(n=83) DB Placebo/OL Viagra=48.4+/-12.2(n=69)
[2] DB Viagra/OL Viagra Male/Female=83/0 DB Placebo/OL Viagra Male/Female=69/0



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8)   [ Week 8 ]

Measure Type Primary
Measure Title Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8)
Measure Description adjusted mean : Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).
Time Frame Week 8  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the Full Analysis Set (FAS) population with an observation

Reporting Groups
  Description
DB Viagra No text entered.
DB Placebo No text entered.

Measured Values
  DB Viagra DB Placebo
Number of Participants Analyzed
[units: participants] 		88 73
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8)
[units: scores on a scale]
Least Squares Mean ± Standard Error 		80.27 ± 2.329 62.15 ± 2.524


Statistical Analysis 1 for Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8)
Groups [1] All groups
Method [2] ANCOVA
P Value [3] <0.0001
Mean Difference (Final Values) [4] 18.13
Standard Error of the mean ± 3.405
95% Confidence Interval ( 11.40 to 24.86 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The primary analysis population was the FAS. The sample size was estimated based on an expected difference of 16.5 with a standard deviation of 28.4, based on previously observed data.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Since there was only one primary endpoint no multiple comparison adjustments were made for primary analysis. Final stat. model included centre, treatment, smoking status and history of ED as factors, and age, duration of ED (baseline) as covariates.
[4] Other relevant estimation information:
  Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.



2.  Secondary:   Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index   [ Week 8, Week 14 ]

Measure Type Secondary
Measure Title Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index
Measure Description Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).
Time Frame Week 8, Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Week 8 No text entered.
DB Viagra/OL Viagra Week 14 No text entered.
DB Placebo Week 8 No text entered.
DB Placebo/OL Viagra Week 14 No text entered.

Measured Values
  DB Viagra Week 8 DB Viagra/OL Viagra Week 14 DB Placebo Week 8 DB Placebo/OL Viagra Week 14
Number of Participants Analyzed
[units: participants] 		88 80 73 67
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index
[units: scores on a scale]
Mean ± Standard Deviation 		79.21 ± 19.646 84.12 ± 17.220 61.64 ± 22.752 87.42 ± 15.124


Statistical Analysis 1 for Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index
Groups [1] DB Viagra Week 8 vs. DB Viagra/OL Viagra Week 14
Method [2] paired t-test
P Value [3] 0.0028
Mean Difference (Net) [4] 5.09
Standard Deviation ± 14.761
95% Confidence Interval ( 1.800 to 8.370 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2 for Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index
Groups [1] DB Placebo Week 8 vs. DB Placebo/OL Viagra Week 14
Method [2] paired t-test
P Value [3] <0.0001
Mean Difference (Net) [4] 26.02
Standard Deviation ± 22.294
95% Confidence Interval ( 20.580 to 31.455 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).



3.  Secondary:   Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score   [ Week 8 ]

Measure Type Secondary
Measure Title Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score
Measure Description adjusted mean change; PREFA Total Score: 8 = worst; 32 = best.
Time Frame Week 8  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra No text entered.
DB Placebo No text entered.

Measured Values
  DB Viagra DB Placebo
Number of Participants Analyzed
[units: participants] 		89 73
Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score
[units: scores on a scale]
Least Squares Mean ± Standard Error 		3.97 ± 0.498 2.21 ± 0.536


Statistical Analysis 1 for Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0080
Mean Difference (Final Values) [4] 1.76
Standard Error of the mean ± 0.656
95% Confidence Interval ( 0.47 to 3.06 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.



4.  Secondary:   Patient Reported Erectile Function Assessment (PREFA) Total Score   [ Week 8, Week 14 ]

Measure Type Secondary
Measure Title Patient Reported Erectile Function Assessment (PREFA) Total Score
Measure Description PREFA Total Score: 8 = worst, 32 = best.
Time Frame Week 8, Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Week 8 No text entered.
DB Viagra /OL Viagra Week 14 No text entered.
DB Placebo Week 8 No text entered.
DB Placebo/OL Viagra Week 14 No text entered.

Measured Values
  DB Viagra Week 8 DB Viagra /OL Viagra Week 14 DB Placebo Week 8 DB Placebo/OL Viagra Week 14
Number of Participants Analyzed
[units: participants] 		89 80 73 67
Patient Reported Erectile Function Assessment (PREFA) Total Score
[units: scores on a scale]
Mean ± Standard Deviation 		28.54 ± 3.468 29.58 ± 2.988 26.79 ± 3.753 29.73 ± 2.895


Statistical Analysis 1 for Patient Reported Erectile Function Assessment (PREFA) Total Score
Groups [1] DB Viagra Week 8 vs. DB Viagra /OL Viagra Week 14
Method [2] paired t-test
P Value [3] 0.0051
Mean Difference (Net) [4] 0.94
Standard Deviation ± 2.909
95% Confidence Interval ( 0.290 to 1.585 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2 for Patient Reported Erectile Function Assessment (PREFA) Total Score
Groups [1] DB Placebo Week 8 vs. DB Placebo/OL Viagra Week 14
Method [2] paired t-test
P Value [3] <0.0001
Mean Difference (Net) [4] 2.79
Standard Deviation ± 4.013
95% Confidence Interval ( 1.812 to 3.770 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).



5.  Secondary:   Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Erectile Function   [ Week 8 ]

Measure Type Secondary
Measure Title Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Erectile Function
Measure Description adjusted mean change - Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).
Time Frame Week 8  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra No text entered.
DB Placebo No text entered.

Measured Values
  DB Viagra DB Placebo
Number of Participants Analyzed
[units: participants] 		89 73
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Erectile Function
[units: scores on a scale]
Least Squares Mean ± Standard Error 		2.08 ± 0.642 -0.53 ± 0.698


Statistical Analysis 1 for Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Erectile Function
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0054
Mean Difference (Final Values) [4] 2.61
Standard Error of the mean ± 0.922
95% Confidence Interval ( 0.78 to 4.43 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.



6.  Secondary:   Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function   [ Week 8 ]

Measure Type Secondary
Measure Title Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function
Measure Description adjusted mean change - Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).
Time Frame Week 8  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra No text entered.
DB Placebo No text entered.

Measured Values
  DB Viagra DB Placebo
Number of Participants Analyzed
[units: participants] 		89 73
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function
[units: scores on a scale]
Least Squares Mean ± Standard Error 		0.59 ± 0.248 0.30 ± 0.271


Statistical Analysis 1 for Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.4232
Mean Difference (Final Values) [4] 0.30
Standard Error of the mean ± 0.368
95% Confidence Interval ( -0.43 to 1.02 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.



7.  Secondary:   Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire   [ Week 8 ]

Measure Type Secondary
Measure Title Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire
Measure Description adjusted mean change - Possible total scores for IIEF-SD range from 2 (worst) to 10 (best).
Time Frame Week 8  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra No text entered.
DB Placebo No text entered.

Measured Values
  DB Viagra DB Placebo
Number of Participants Analyzed
[units: participants] 		89 73
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire
[units: scores on a scale]
Least Squares Mean ± Standard Error 		0.60 ± 0.207 -0.08 ± 0.223


Statistical Analysis 1 for Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0156
Mean Difference (Final Values) [4] 0.68
Standard Error of the mean ± 0.277
95% Confidence Interval ( 0.13 to 1.22 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.



8.  Secondary:   Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction   [ Week 8 ]

Measure Type Secondary
Measure Title Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction
Measure Description adjusted mean - Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).
Time Frame Week 8  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra No text entered.
DB Placebo No text entered.

Measured Values
  DB Viagra DB Placebo
Number of Participants Analyzed
[units: participants] 		89 73
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction
[units: scores on a scale]
Least Squares Mean ± Standard Error 		2.20 ± 0.365 1.00 ± 0.390


Statistical Analysis 1 for Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0096
Mean Difference (Final Values) [4] 1.20
Standard Error of the mean ± 0.458
95% Confidence Interval ( 0.30 to 2.11 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.



9.  Secondary:   Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction   [ Week 8 ]

Measure Type Secondary
Measure Title Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction
Measure Description adjusted mean change - Possible total scores for IIEF-OS range from 2 (worst) to 10 (best).
Time Frame Week 8  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra No text entered.
DB Placebo No text entered.

Measured Values
  DB Viagra DB Placebo
Number of Participants Analyzed
[units: participants] 		89 73
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction
[units: scores on a scale]
Least Squares Mean ± Standard Error 		2.35 ± 0.254 1.46 ± 0.275


Statistical Analysis 1 for Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0135
Mean Difference (Final Values) [4] 0.90
Standard Error of the mean ± 0.359
95% Confidence Interval ( 0.19 to 1.61 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.



10.  Secondary:   International Index of Erectile Function (IIEF) Domain Scores- Erectile Function   [ Week 8, Week 14 ]

Measure Type Secondary
Measure Title International Index of Erectile Function (IIEF) Domain Scores- Erectile Function
Measure Description Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).
Time Frame Week 8, Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Week 8 No text entered.
DB Viagra/OL Viagra Week 14 No text entered.
DB Placebo Week 8 No text entered.
DB Placebo/OL Viagra Week 14 No text entered.

Measured Values
  DB Viagra Week 8 DB Viagra/OL Viagra Week 14 DB Placebo Week 8 DB Placebo/OL Viagra Week 14
Number of Participants Analyzed
[units: participants] 		89 80 73 67
International Index of Erectile Function (IIEF) Domain Scores- Erectile Function
[units: scores on a scale]
Mean ± Standard Deviation 		24.92 ± 5.375 26.43 ± 5.023 22.40 ± 6.403 27.67 ± 3.573


Statistical Analysis 1 for International Index of Erectile Function (IIEF) Domain Scores- Erectile Function
Groups [1] DB Viagra Week 8 vs. DB Viagra/OL Viagra Week 14
Method [2] paired t-test
P Value [3] 0.0033
Mean Difference (Net) [4] 1.49
Standard Deviation ± 4.392
95% Confidence Interval ( 0.0510 to 2.465 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2 for International Index of Erectile Function (IIEF) Domain Scores- Erectile Function
Groups [1] DB Placebo Week 8 vs. DB Placebo/OL Viagra Week 14
Method [2] paired t-test
P Value [3] <0.0001
Mean Difference (Net) [4] 5.22
Standard Deviation ± 6.346
95% Confidence Interval ( 3.676 to 6.772 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).



11.  Secondary:   International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function   [ Week 8, Week 14 ]

Measure Type Secondary
Measure Title International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function
Measure Description Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).
Time Frame Week 8, Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Week 8 No text entered.
DB Viagra/OL Viagra Week 14 No text entered.
DB Placebo Week 8 No text entered.
DB Placebo/OL Viagra Week 14 No text entered.

Measured Values
  DB Viagra Week 8 DB Viagra/OL Viagra Week 14 DB Placebo Week 8 DB Placebo/OL Viagra Week 14
Number of Participants Analyzed
[units: participants] 		89 80 73 67
International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function
[units: scores on a scale]
Mean ± Standard Deviation 		8.62 ± 1.812 8.95 ± 1.598 7.81 ± 2.564 9.21 ± 1.213


Statistical Analysis 1 for International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function
Groups [1] DB Viagra Week 8 vs. DB Viagra/OL Viagra Week 14
Method [2] paired t-test
P Value [3] 0.2581
Mean Difference (Net) [4] 0.20
Standard Deviation ± 1.570
95% Confidence Interval ( -0.149 to 0.549 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2 for International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function
Groups [1] DB Placebo Week 8 vs. DB Placebo/OL Viagra Week 14
Method [2] paired t-test
P Value [3] <0.0001
Mean Difference (Net) [4] 1.39
Standard Deviation ± 2.582
95% Confidence Interval ( 0.758 to 2.018 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).



12.  Secondary:   International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire   [ Week 8, Week 14 ]

Measure Type Secondary
Measure Title International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire
Measure Description Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).
Time Frame Week 8, Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Week 8 No text entered.
DB Viagra/OL Viagra Week 14 No text entered.
DB Placebo Week 8 No text entered.
DB Placebo/OL Viagra Week 14 No text entered.

Measured Values
  DB Viagra Week 8 DB Viagra/OL Viagra Week 14 DB Placebo Week 8 DB Placebo/OL Viagra Week 14
Number of Participants Analyzed
[units: participants] 		89 80 73 67
International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire
[units: scores on a scale]
Mean ± Standard Deviation 		7.90 ± 1.665 8.10 ± 1.539 7.37 ± 1.712 8.18 ± 1.230


Statistical Analysis 1 for International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire
Groups [1] DB Viagra Week 8 vs. DB Viagra/OL Viagra Week 14
Method [2] paired t-test
P Value [3] 0.2857
Mean Difference (Net) [4] 0.18
Standard Deviation ± 1.456
95% Confidence Interval ( -0.149 to 0.499 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2 for International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire
Groups [1] DB Placebo Week 8 vs. DB Placebo/OL Viagra Week 14
Method [2] paired t-test
P Value [3] 0.0005
Mean Difference (Net) [4] 0.76
Standard Deviation ± 1.706
95% Confidence Interval ( 0.345 to 1.177 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).



13.  Secondary:   International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction   [ Week 8, Week 14 ]

Measure Type Secondary
Measure Title International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction
Measure Description Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).
Time Frame Week 8, Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Week 8 No text entered.
DB Viagra/OL Viagra Week 14 No text entered.
DB Placebo Week 8 No text entered.
DB Placebo/OL Viagra Week 14 No text entered.

Measured Values
  DB Viagra Week 8 DB Viagra/OL Viagra Week 14 DB Placebo Week 8 DB Placebo/OL Viagra Week 14
Number of Participants Analyzed
[units: participants] 		89 80 73 67
International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction
[units: scores on a scale]
Mean ± Standard Deviation 		11.82 ± 2.806 12.64 ± 2.367 10.84 ± 2.635 13.12 ± 1.943


Statistical Analysis 1 for International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction
Groups [1] DB Viagra Week 8 vs. DB Viagra/OL Viagra Week 14
Method [2] paired t-test
P Value [3] 0.0102
Mean Difference (Net) [4] 0.75
Standard Deviation ± 2.548
95% Confidence Interval ( 0.183 to 1.317 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2 for International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction
Groups [1] DB Placebo Week 8 vs. DB Placebo/OL Viagra Week 14
Method [2] paired t-test
P Value [3] <0.0001
Mean Difference (Net) [4] 2.28
Standard Deviation ± 2.979
95% Confidence Interval ( 1.557 to 3.010 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).



14.  Secondary:   International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction   [ Week 8, Week 14 ]

Measure Type Secondary
Measure Title International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction
Measure Description Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).
Time Frame Week 8, Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Week 8 No text entered.
DB Viagra/OL Viagra Week 14 No text entered.
DB Placebo Week 8 No text entered.
DB Placebo/OL Viagra Week 14 No text entered.

Measured Values
  DB Viagra Week 8 DB Viagra/OL Viagra Week 14 DB Placebo Week 8 DB Placebo/OL Viagra Week 14
Number of Participants Analyzed
[units: participants] 		89 80 73 67
International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction
[units: scores on a scale]
Mean ± Standard Deviation 		8.19 ± 1.827 8.94 ± 1.656 7.25 ± 2.178 9.12 ± 1.332


Statistical Analysis 1 for International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction
Groups [1] DB Viagra Week 8 vs. DB Viagra/OL Viagra Week 14
Method [2] paired t-test
P Value [3] 0.0016
Mean Difference (Net) [4] 0.68
Standard Deviation ± 1.847
95% Confidence Interval ( 0.264 to 1.086 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2 for International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction
Groups [1] DB Placebo Week 8 vs. DB Placebo/OL Viagra Week 14
Method [2] paired t-test
P Value [3] <0.0001
Mean Difference (Net) [4] 1.90
Standard Deviation ± 2.297
95% Confidence Interval ( 1.335 to 2.456 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).



15.  Secondary:   Change From Baseline to End of DB Phase (Week 8) in Erectile Distress Scale (EDS) Total Score   [ Week 8 ]

Measure Type Secondary
Measure Title Change From Baseline to End of DB Phase (Week 8) in Erectile Distress Scale (EDS) Total Score
Measure Description adjusted mean change - Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.
Time Frame Week 8  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra No text entered.
DB Placebo No text entered.

Measured Values
  DB Viagra DB Placebo
Number of Participants Analyzed
[units: participants] 		89 73
Change From Baseline to End of DB Phase (Week 8) in Erectile Distress Scale (EDS) Total Score
[units: scores on a scale]
Least Squares Mean ± Standard Error 		5.14 ± 0.870 2.36 ± 0.926


Statistical Analysis 1 for Change From Baseline to End of DB Phase (Week 8) in Erectile Distress Scale (EDS) Total Score
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0083
Mean Difference (Final Values) [4] 2.78
Standard Error of the mean ± 1.038
95% Confidence Interval ( 0.73 to 4.83 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.



16.  Secondary:   Erectile Distress Scale (EDS) Total Score   [ Week 8, Week 14 ]

Measure Type Secondary
Measure Title Erectile Distress Scale (EDS) Total Score
Measure Description Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.
Time Frame Week 8, Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Week 8 No text entered.
DB Viagra/OL Viagra Week 14 No text entered.
DB Placebo Week 8 No text entered.
DB Placebo/OL Viagra Week 14 No text entered.

Measured Values
  DB Viagra Week 8 DB Viagra/OL Viagra Week 14 DB Placebo Week 8 DB Placebo/OL Viagra Week 14
Number of Participants Analyzed
[units: participants] 		89 80 73 67
Erectile Distress Scale (EDS) Total Score
[units: scores on a scale]
Mean ± Standard Deviation 		24.58 ± 6.039 24.55 ± 6.552 21.23 ± 6.246 26.58 ± 4.717


Statistical Analysis 1 for Erectile Distress Scale (EDS) Total Score
Groups [1] DB Viagra Week 8 vs. DB Viagra/OL Viagra Week 14
Method [2] paired t-test
P Value [3] 0.9146
Mean Difference (Net) [4] -0.06
Standard Deviation ± 5.193
95% Confidence Interval ( -1.218 to 1.093 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2 for Erectile Distress Scale (EDS) Total Score
Groups [1] DB Placebo Week 8 vs. DB Placebo/OL Viagra Week 14
Method [2] paired t-test
P Value [3] <0.0001
Mean Difference (Net) [4] 5.54
Standard Deviation ± 6.463
95% Confidence Interval ( 3.961 to 7.114 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).



17.  Secondary:   Change From Baseline to End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score   [ Week 8 ]

Measure Type Secondary
Measure Title Change From Baseline to End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score
Measure Description adjusted mean change - QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).
Time Frame Week 8  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra No text entered.
DB Placebo No text entered.

Measured Values
  DB Viagra DB Placebo
Number of Participants Analyzed
[units: participants] 		89 73
Change From Baseline to End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score
[units: scores on a scale]
Least Squares Mean ± Standard Error 		24.04 ± 3.260 5.62 ± 3.558


Statistical Analysis 1 for Change From Baseline to End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0002
Mean Difference (Final Values) [4] 18.42
Standard Error of the mean ± 4.826
95% Confidence Interval ( 8.88 to 27.96 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.



18.  Secondary:   Quality of Erection Questionnaire (QEQ) Total Score   [ Week 8, Week 14 ]

Measure Type Secondary
Measure Title Quality of Erection Questionnaire (QEQ) Total Score
Measure Description QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).
Time Frame Week 8, Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set

Reporting Groups
  Description
DB Viagra Week 8 No text entered.
DB Viagra/OL Viagra Week 14 No text entered.
DB Placebo Week 8 No text entered.
DB Placebo/OL Viagra Week 14 No text entered.

Measured Values
  DB Viagra Week 8 DB Viagra/OL Viagra Week 14 DB Placebo Week 8 DB Placebo/OL Viagra Week 14
Number of Participants Analyzed
[units: participants] 		89 80 73 67
Quality of Erection Questionnaire (QEQ) Total Score
[units: scores on a scale]
Mean ± Standard Deviation 		80.20 ± 23.954 86.46 ± 20.918 63.64 ± 28.559 89.74 ± 17.473


Statistical Analysis 1 for Quality of Erection Questionnaire (QEQ) Total Score
Groups [1] DB Viagra Week 8 vs. DB Viagra/OL Viagra Week 14
Method [2] paired t-test
P Value [3] 0.0064
Mean Difference (Net) [4] 6.41
Standard Deviation ± 20.444
95% Confidence Interval ( 1.857 to 10.956 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2 for Quality of Erection Questionnaire (QEQ) Total Score
Groups [1] DB Placebo Week 8 vs. DB Placebo/OL Viagra Week 14
Method [2] paired t-test
P Value [3] <0.0001)
Mean Difference (Net) [4] 26.80
Standard Deviation ± 29.384
95% Confidence Interval ( 19.636 to 33.971 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).



19.  Secondary:   Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)   [ Week 8, Week 14 ]

Measure Type Secondary
Measure Title Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)
Measure Description GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections?Responder was defined as answering “Yes”. % of responders/non-responders was calculated based on subjects who attempted intercourse.
Time Frame Week 8, Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
Week 8 DB Viagra No text entered.
Week 8 DB Placebo No text entered.
Week 14 DB Viagra/OL Viagra No text entered.
Week 14 DB Placebo/OL Viagra No text entered.

Measured Values
  Week 8 DB Viagra Week 8 DB Placebo Week 14 DB Viagra/OL Viagra Week 14 DB Placebo/OL Viagra
Number of Participants Analyzed
[units: participants] 		88 73 80 67
Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)
[units: percentage of subjects]
 		       
GEQ1 Responder 81.8 43.8 90.0 94.0
GEQ1 Non-Responder 18.2 56.2 10.0 6.0


Statistical Analysis 1 for Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)
Groups [1] Week 8 DB Viagra vs. Week 8 DB Placebo
Method [2] Regression, Logistic
P Value [3] 0.0001
Odds Ratio (OR) [4] 6.491
95% Confidence Interval ( 3.042 to 13.851 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



20.  Secondary:   Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)   [ Week 8, Week 14 ]

Measure Type Secondary
Measure Title Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)
Measure Description GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering “Yes”. % of responders/non-responders was calculated based on subjects who attempted intercourse.
Time Frame Week 8, Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
Week 8 DB Viagra No text entered.
Week 8 DB Placebo No text entered.
Week 14 DB Viagra/OL Viagra No text entered.
Week 14 DB Placebo/OL Viagra No text entered.

Measured Values
  Week 8 DB Viagra Week 8 DB Placebo Week 14 DB Viagra/OL Viagra Week 14 DB Placebo/OL Viagra
Number of Participants Analyzed
[units: participants] 		88 73 80 67
Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)
[units: percentage of subjects]
 		       
GEQ2 Responder 79.3 45.2 86.3 92.5
GEQ2 Non-Responder 20.7 54.8 13.8 7.5


Statistical Analysis 1 for Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)
Groups [1] Week 8 DB Viagra vs. Week 8 DB Placebo
Method [2] Regression, Logistic
P Value [3] <0.0001
Odds Ratio (OR) [4] 4.915
95% Confidence Interval ( 2.396 to 10.080 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



21.  Secondary:   Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)   [ Week 8, Week 14 ]

Measure Type Secondary
Measure Title Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)
Measure Description GEQ 3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Resp. was defined as answering almost always or always, most times, or sometimes, and non-resp was defined as answering a few times or almost never or never.
Time Frame Week 8, Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
Week 8 DB Viagra No text entered.
Week 8 DB Placebo No text entered.
Week 14 DB Viagra/OL Viagra No text entered.
Week 14 DB Placebo/OL Viagra No text entered.

Measured Values
  Week 8 DB Viagra Week 8 DB Placebo Week 14 DB Viagra/OL Viagra Week 14 DB Placebo/OL Viagra
Number of Participants Analyzed
[units: participants] 		88 73 80 67
Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)
[units: percentage of subjects]
 		       
GEQ3 Responders 94.3 81.7 95.0 98.5
GEQ3 Non-Responders 5.7 18.3 5.0 1.5


Statistical Analysis 1 for Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)
Groups [1] Week 8 DB Viagra vs. Week 8 DB Placebo
Method [2] Regression, Logistic
P Value [3] 0.0187
Odds Ratio (OR) [4] 3.676
95% Confidence Interval ( 1.242 to 10.875 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



22.  Secondary:   Percentage of Occasions of Successful Intercourse (Event Log)   [ Baseline to Week 8 ]

Measure Type Secondary
Measure Title Percentage of Occasions of Successful Intercourse (Event Log)
Measure Description Percentage of occasions at which subjects answered “yes” to the question “Did your erection last long enough to have successful intercourse?”. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.
Time Frame Baseline to Week 8  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
DB Placebo Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).

Measured Values
  DB Viagra DB Placebo
Number of Participants Analyzed
[units: participants] 		88 73
Percentage of Occasions of Successful Intercourse (Event Log)
[units: percentage of occasions]
Mean ± Standard Deviation 		73.64 ± 26.689 59.73 ± 33.332


Statistical Analysis 1 for Percentage of Occasions of Successful Intercourse (Event Log)
Groups [1] All groups
Method [2] independent-samples t-test
P Value [3] 0.0037
Mean Difference (Net) [4] 13.90
Standard Error of the mean ± 4.716
95% Confidence Interval ( 4.59 to 23.22 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.



23.  Secondary:   Percentage of Occasions of Ejaculation and/or Orgasm (Event Log)   [ Baseline to Week 8 ]

Measure Type Secondary
Measure Title Percentage of Occasions of Ejaculation and/or Orgasm (Event Log)
Measure Description Percentage of occasions at which subjects answered “yes” to the question “Did you ejaculate and/or have an orgasm?”. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.
Time Frame Baseline to Week 8  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
DB Placebo Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).

Measured Values
  DB Viagra DB Placebo
Number of Participants Analyzed
[units: participants] 		88 73
Percentage of Occasions of Ejaculation and/or Orgasm (Event Log)
[units: Percentage of occasions]
Mean ± Standard Deviation 		74.31 ± 25.300 64.60 ± 31.903


Statistical Analysis 1 for Percentage of Occasions of Ejaculation and/or Orgasm (Event Log)
Groups [1] All groups
Method [2] independent-samples t-test
P Value [3] 0.0321
Mean Difference (Net) [4] 9.72
Standard Error of the mean ± 4.496
95% Confidence Interval ( 0.84 to 18.60 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Mean Difference = Week 8 - Baseline



24.  Secondary:   Percentage of Occasions of Successful Intercourse (Event Log)   [ Week 8 to Week 14 ]

Measure Type Secondary
Measure Title Percentage of Occasions of Successful Intercourse (Event Log)
Measure Description Percentage of occasions at which subjects answered “yes” to the question “Did your erection last long enough to have successful intercourse?”. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.
Time Frame Week 8 to Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra / OL Viagra Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
DB Placebo/OL Viagra Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).

Measured Values
  DB Viagra / OL Viagra DB Placebo/OL Viagra
Number of Participants Analyzed
[units: participants] 		80 67
Percentage of Occasions of Successful Intercourse (Event Log)
[units: percentage of occasions]
Mean ± Standard Deviation 		79.65 ± 25.309 87.63 ± 21.936


Statistical Analysis 1 for Percentage of Occasions of Successful Intercourse (Event Log)
Groups [1] All groups
Method [2] independent-samples t-test
P Value [3] 0.0427
Mean Difference (Net) [4] -7.97
Standard Error of the mean ± 3.901
95% Confidence Interval ( -15.68 to -0.27 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.



25.  Secondary:   Percentage of Occasions of Ejaculation and/or Orgasm (Event Log)   [ Week 8 to Week 14 ]

Measure Type Secondary
Measure Title Percentage of Occasions of Ejaculation and/or Orgasm (Event Log)
Measure Description Percentage of occasions at which subjects answered “yes” to the question “Did you ejaculate and/or have an orgasm?”. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.
Time Frame Week 8 to Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra / OL Viagra Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
DB Placebo/OL Viagra Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).

Measured Values
  DB Viagra / OL Viagra DB Placebo/OL Viagra
Number of Participants Analyzed
[units: participants] 		80 67
Percentage of Occasions of Ejaculation and/or Orgasm (Event Log)
[units: percentage of occasions]
Mean ± Standard Deviation 		77.69 ± 25.099 85.29 ± 22.257


Statistical Analysis 1 for Percentage of Occasions of Ejaculation and/or Orgasm (Event Log)
Groups [1] All groups
Method [2] independent-samples t-test
P Value [3] 0.0533
Mean Difference (Net) [4] -7.60
Standard Error of the mean ± 3.903
95% Confidence Interval ( -15.32 to 0.11 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.



26.  Secondary:   Change From Baseline to Week 8 in Analog Scales- Firmness   [ baseline to Week 8 ]

Measure Type Secondary
Measure Title Change From Baseline to Week 8 in Analog Scales- Firmness
Measure Description mean change - scale of 0 (worst) to 10 (best).
Time Frame baseline to Week 8  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra No text entered.
DB Placebo No text entered.

Measured Values
  DB Viagra DB Placebo
Number of Participants Analyzed
[units: participants] 		89 73
Change From Baseline to Week 8 in Analog Scales- Firmness
[units: units on a scale]
Mean ± Standard Deviation 		1.55 ± 2.023 0.38 ± 1.800


Statistical Analysis 1 for Change From Baseline to Week 8 in Analog Scales- Firmness
Groups [1] All groups
Method [2] 2-sample independent t-test
P Value [3] 0.0002
Mean Difference (Net) [4] 1.1670
Standard Error of the mean ± 0.3041
95% Confidence Interval ( 0.566 to 1.768 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).



27.  Secondary:   Change From Baseline to Week 8 in Analog Scales- Maintenance   [ baseline to Week 8 ]

Measure Type Secondary
Measure Title Change From Baseline to Week 8 in Analog Scales- Maintenance
Measure Description mean change - scale of 0 (worst) to 10 (best).
Time Frame baseline to Week 8  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
DB Placebo Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).

Measured Values
  DB Viagra DB Placebo
Number of Participants Analyzed
[units: participants] 		89 73
Change From Baseline to Week 8 in Analog Scales- Maintenance
[units: units on a scale]
Mean ± Standard Deviation 		1.84 ± 2.421 0.40 ± 2.152


Statistical Analysis 1 for Change From Baseline to Week 8 in Analog Scales- Maintenance
Groups [1] All groups
Method [2] 2-sample independent t-test
P Value [3] 0.0001
Mean Difference (Net) [4] 1.4454
Standard Error of the mean ± 0.3638
95% Confidence Interval ( 0.727 to 2.164 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).



28.  Secondary:   Change From Baseline to Week 8 in Analog Scales- Reliability   [ baseline to Week 8 ]

Measure Type Secondary
Measure Title Change From Baseline to Week 8 in Analog Scales- Reliability
Measure Description mean change - scale of 0 (worst) to 10 (best).
Time Frame baseline to Week 8  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
DB Placebo Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).

Measured Values
  DB Viagra DB Placebo
Number of Participants Analyzed
[units: participants] 		89 73
Change From Baseline to Week 8 in Analog Scales- Reliability
[units: units on a scale]
Mean ± Standard Deviation 		1.61 ± 2.795 0.42 ± 2.081


Statistical Analysis 1 for Change From Baseline to Week 8 in Analog Scales- Reliability
Groups [1] All groups
Method [2] 2-sample independent t-test
P Value [3] 0.0032
Mean Difference (Net) [4] 1.1821
Standard Error of the mean ± 0.3946
95% Confidence Interval ( 0.403 to 1.961 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).



29.  Secondary:   Change From Baseline to Week 8 in Analog Scales- General Sexual Performance   [ baseline to week 8 ]

Measure Type Secondary
Measure Title Change From Baseline to Week 8 in Analog Scales- General Sexual Performance
Measure Description mean change - scale of 0 (worst) to 10 (best)
Time Frame baseline to week 8  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
DB Placebo Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).

Measured Values
  DB Viagra DB Placebo
Number of Participants Analyzed
[units: participants] 		89 73
Change From Baseline to Week 8 in Analog Scales- General Sexual Performance
[units: units on a scale]
Mean ± Standard Deviation 		1.72 ± 2.355 0.51 ± 2.109


Statistical Analysis 1 for Change From Baseline to Week 8 in Analog Scales- General Sexual Performance
Groups [1] All groups
Method [2] 2-sample independent t-test
P Value [3] 0.0008
Mean Difference (Net) [4] 1.2123
Standard Error of the mean ± 0.3549
95% Confidence Interval ( 0.511 to 1.913 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).



30.  Secondary:   Analog Scales- Firmness   [ Week 8, Week 14 ]

Measure Type Secondary
Measure Title Analog Scales- Firmness
Measure Description mean - scale of 0 (worst) to 10 (best)
Time Frame Week 8, Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Week 8 No text entered.
DB Viagra/OL Viagra Week 14 No text entered.
DB Placebo Week 8 No text entered.
DB Placebo/OL Viagra Week 14 No text entered.

Measured Values
  DB Viagra Week 8 DB Viagra/OL Viagra Week 14 DB Placebo Week 8 DB Placebo/OL Viagra Week 14
Number of Participants Analyzed
[units: participants] 		89 80 73 67
Analog Scales- Firmness
[units: units on a scale]
Mean ± Standard Deviation 		7.87 ± 1.872 8.25 ± 1.932 6.60 ± 2.171 8.64 ± 1.264


Statistical Analysis 1 for Analog Scales- Firmness
Groups [1] DB Viagra Week 8 vs. DB Viagra/OL Viagra Week 14
Method [2] paired t-test
P Value [3] 0.0195
Mean Difference (Net) [4] 0.39
Standard Deviation ± 1.454
95% Confidence Interval ( 0.064 to 0.711 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2 for Analog Scales- Firmness
Groups [1] DB Placebo Week 8 vs. DB Placebo/OL Viagra Week 14
Method [2] paired t-test
P Value [3] <0.0001
Mean Difference (Net) [4] 2.09
Standard Deviation ± 2.207
95% Confidence Interval ( 1.551 to 2.628 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).



31.  Secondary:   Analog Scales- Maintenance   [ Week 8, Week 14 ]

Measure Type Secondary
Measure Title Analog Scales- Maintenance
Measure Description mean - scale of 0 (worst) to 10 (best)
Time Frame Week 8, Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Week 8 No text entered.
DB Viagra/OL Viagra Week 14 No text entered.
DB Placebo Week 8 No text entered.
DB Placebo/OL Viagra Week 14 No text entered.

Measured Values
  DB Viagra Week 8 DB Viagra/OL Viagra Week 14 DB Placebo Week 8 DB Placebo/OL Viagra Week 14
Number of Participants Analyzed
[units: participants] 		89 80 73 67
Analog Scales- Maintenance
[units: units on a scale]
Mean ± Standard Deviation 		7.65 ± 2.138 8.01 ± 2.155 5.99 ± 2.519 8.55 ± 1.617


Statistical Analysis 1 for Analog Scales- Maintenance
Groups [1] DB Viagra Week 8 vs. DB Viagra/OL Viagra Week 14
Method [2] paired t-test
P Value [3] 0.0186
Mean Difference (Net) [4] 0.40
Standard Deviation ± 1.489
95% Confidence Interval ( 0.069 to 0.731 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2 for Analog Scales- Maintenance
Groups [1] DB Placebo Week 8 vs. DB Placebo/OL Viagra Week 14
Method [2] paired t-test
P Value [3] <0.0001
Mean Difference (Net) [4] 2.67
Standard Deviation ± 2.573
95% Confidence Interval ( 2.044 to 3.299 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).



32.  Secondary:   Analog Scales- Reliability   [ Week 8, Week 14 ]

Measure Type Secondary
Measure Title Analog Scales- Reliability
Measure Description mean - scale of 0 (worst) to 10 (best)
Time Frame Week 8, Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Week 8 No text entered.
DB Viagra/OL Viagra Week 14 No text entered.
DB Placebo Week 8 No text entered.
DB Placebo/OL Viagra Week 14 No text entered.

Measured Values
  DB Viagra Week 8 DB Viagra/OL Viagra Week 14 DB Placebo Week 8 DB Placebo/OL Viagra Week 14
Number of Participants Analyzed
[units: participants] 		89 80 73 67
Analog Scales- Reliability
[units: units on a scale]
Mean ± Standard Deviation 		7.35 ± 2.360 7.96 ± 2.292 6.04 ± 2.306 8.55 ± 1.550


Statistical Analysis 1 for Analog Scales- Reliability
Groups [1] DB Viagra Week 8 vs. DB Viagra/OL Viagra Week 14
Method [2] paired t-test
P Value [3] 0.0033
Mean Difference (Net) [4] 0.65
Standard Deviation ± 1.917
95% Confidence Interval ( 0.223 to 1.077 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2 for Analog Scales- Reliability
Groups [1] DB Placebo Week 8 vs. DB Placebo/OL Viagra Week 14
Method [2] paired t-test
P Value [3] <0.0001
Mean Difference (Net) [4] 2.61
Standard Deviation ± 2.335
95% Confidence Interval ( 2.042 to 3.182 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).



33.  Secondary:   Analog Scales- General Sexual Performance   [ Week 8, Week 14 ]

Measure Type Secondary
Measure Title Analog Scales- General Sexual Performance
Measure Description mean - scale of 0 (worst) to 10 (best)
Time Frame Week 8, Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Week 8 No text entered.
DB Viagra/OL Viagra Week 14 No text entered.
DB Placebo Week 8 No text entered.
DB Placebo/OL Viagra Week 14 No text entered.

Measured Values
  DB Viagra Week 8 DB Viagra/OL Viagra Week 14 DB Placebo Week 8 DB Placebo/OL Viagra Week 14
Number of Participants Analyzed
[units: participants] 		89 80 73 67
Analog Scales- General Sexual Performance
[units: units on a scale]
Mean ± Standard Deviation 		7.58 ± 2.077 8.01 ± 1.978 6.53 ± 2.128 8.49 ± 1.319


Statistical Analysis 1 for Analog Scales- General Sexual Performance
Groups [1] DB Viagra Week 8 vs. DB Viagra/OL Viagra Week 14
Method [2] paired t-test
P Value [3] 0.0143
Mean Difference (Net) [4] 0.45
Standard Deviation ± 1.606
95% Confidence Interval ( 0.093 to 0.807 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2 for Analog Scales- General Sexual Performance
Groups [1] DB Placebo Week 8 vs. DB Placebo/OL Viagra Week 14
Method [2] paired t-test
P Value [3] <0.0001
Mean Difference (Net) [4] 1.99
Standard Deviation ± 2.178
95% Confidence Interval ( 1.454 to 2.516 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).



34.  Secondary:   Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1   [ Week 8 to Week 14 ]

Measure Type Secondary
Measure Title Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1
Measure Description GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections? Responder was defined as answering Yes to GEQ 1.
Time Frame Week 8 to Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation: Number of subjects with both Week 8 and Week 14 response to GEQ Question 1 under the treatment.

Reporting Groups
  Description
DB Viagra / OL Viagra No text entered.
DB Placebo/ OL Viagra No text entered.

Measured Values
  DB Viagra / OL Viagra DB Placebo/ OL Viagra
Number of Participants Analyzed
[units: participants] 		80 67
Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1
[units: subjects]
 		   
Responder at Week 8 / Responder at Week 14 61 27
Responder at Week 8 / Non-Responder at Week 14 3 0
Non-Responder at Week 8 / Responder at Week 14 11 36
Non-Responder at Week 8 / Non-Responder at Week 14 5 4


Statistical Analysis 1 for Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1
Groups [1] DB Viagra / OL Viagra
Method [2] McNemar
P Value [3] 0.0325
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1
Groups [1] DB Placebo/ OL Viagra
Method [2] McNemar
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



35.  Secondary:   Shift in Responder Rate From Week 8 to Week 14 for GEQ2   [ Week 8 to Week 14 ]

Measure Type Secondary
Measure Title Shift in Responder Rate From Week 8 to Week 14 for GEQ2
Measure Description GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering Yes to GEQ 2.
Time Frame Week 8 to Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation: Number of subjects with both Week 8 and Week 14 response to GEQ Question 2 under the treatment.

Reporting Groups
  Description
DB Viagra / OL Viagra No text entered.
DB Placebo / OL Viagra No text entered.

Measured Values
  DB Viagra / OL Viagra DB Placebo / OL Viagra
Number of Participants Analyzed
[units: participants] 		79 67
Shift in Responder Rate From Week 8 to Week 14 for GEQ2
[units: subjects]
 		   
Responder at Week 8 / Responder at Week 14 60 29
Responder at Week 8 / Non-Responder at Week 14 1 0
Non-Responder at Week 8 / Responder at Week 14 8 33
Non-Responder at Week 8 / Non-Responder at Week 14 10 5


Statistical Analysis 1 for Shift in Responder Rate From Week 8 to Week 14 for GEQ2
Groups [1] DB Viagra / OL Viagra
Method [2] McNemar
P Value [3] 0.0196
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Shift in Responder Rate From Week 8 to Week 14 for GEQ2
Groups [1] DB Placebo / OL Viagra
Method [2] McNemar
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



36.  Secondary:   Shift in Responder Rate From Week 8 to Week 14 for GEQ3   [ Week 8 to Week 14 ]

Measure Type Secondary
Measure Title Shift in Responder Rate From Week 8 to Week 14 for GEQ3
Measure Description GEQ3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Responder = almost always or always, most times, or sometimes. Non-responder = a few times (much less than half the time) or almost never or never.
Time Frame Week 8 to Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation: Number of subjects with both Week 8 and Week 14 response to GEQ Question 3 under the treatment.

Reporting Groups
  Description
DB Viagra / OL Viagra No text entered.
DB Placebo / OL Viagra No text entered.

Measured Values
  DB Viagra / OL Viagra DB Placebo / OL Viagra
Number of Participants Analyzed
[units: participants] 		79 65
Shift in Responder Rate From Week 8 to Week 14 for GEQ3
[units: subjects]
 		   
Responder at Week 8 / Responder at Week 14 74 54
Responder at Week 8 / Non-Responder at Week 14 0 0
Non-Responder at Week 8 / Responder at Week 14 1 10
Non-Responder at Week 8 / Non-Responder at Week 14 4 1


Statistical Analysis 1 for Shift in Responder Rate From Week 8 to Week 14 for GEQ3
Groups [1] DB Viagra / OL Viagra
Method [2] McNemar
P Value [3] 0.3173
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Shift in Responder Rate From Week 8 to Week 14 for GEQ3
Groups [1] DB Placebo / OL Viagra
Method [2] McNemar
P Value [3] 0.0016
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



37.  Secondary:   Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0   [ Baseline to <Week 8 and Week 8 to <=Week 14 ]

Measure Type Secondary
Measure Title Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0
Measure Description Per-patient percentage of hardness of erections:Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.
Time Frame Baseline to <Week 8 and Week 8 to <=Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Baseline < Week 8 No text entered.
DB Placebo Baseline to < Week 8 No text entered.
DB Viagra/OL Viagra Week 8 to <=Week 14 No text entered.
DB Placebo/OL Viagra Week 8 to <=Week 14 No text entered.

Measured Values
  DB Viagra Baseline < Week 8 DB Placebo Baseline to < Week 8 DB Viagra/OL Viagra Week 8 to <=Week 14 DB Placebo/OL Viagra Week 8 to <=Week 14
Number of Participants Analyzed
[units: participants] 		88 74 83 68
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0
[units: percentage of occasions]
Mean ± Standard Deviation 		7.09 ± 13.041 12.64 ± 23.834 4.50 ± 12.217 3.12 ± 9.855


Statistical Analysis 1 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0
Groups [1] DB Viagra Baseline < Week 8 vs. DB Placebo Baseline to < Week 8
Method [2] Independent-samples t-test
P Value [3] 0.0624
Mean Difference (Net) [4] -5.55
Standard Error of the mean ± 2.958
95% Confidence Interval ( -11.39 to 0.29 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0
Groups [1] DB Viagra/OL Viagra Week 8 to <=Week 14 vs. DB Placebo/OL Viagra Week 8 to <=Week 14
Method [2] Independent-samples t-test
P Value [3] 0.4523
Mean Difference (Net) [4] 1.38
Standard Error of the mean ± 1.835
95% Confidence Interval ( -2.24 to 5.01 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.



38.  Secondary:   Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1   [ Baseline to <= Week 14 ]

Measure Type Secondary
Measure Title Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1
Measure Description Per-patient percentage of hardness of erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.
Time Frame Baseline to <= Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Baseline < Week 8 No text entered.
DB Placebo Baseline < Week 8 No text entered.
DB Viagra/OL Viagra Week 8 to <=Week 14 No text entered.
DB Placebo/OL Viagra Week 8 to <=Week 14 No text entered.

Measured Values
  DB Viagra Baseline < Week 8 DB Placebo Baseline < Week 8 DB Viagra/OL Viagra Week 8 to <=Week 14 DB Placebo/OL Viagra Week 8 to <=Week 14
Number of Participants Analyzed
[units: participants] 		88 74 83 68
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1
[units: percentage of occasions]
Mean ± Standard Deviation 		3.83 ± 9.600 6.31 ± 15.144 3.48 ± 14.300 1.88 ± 8.269


Statistical Analysis 1 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1
Groups [1] DB Viagra Baseline < Week 8 vs. DB Placebo Baseline < Week 8
Method [2] Independent-samples t-test
P Value [3] 0.2081
Mean Difference (Net) [4] -2.48
Standard Error of the mean ± 1.962
95% Confidence Interval ( -6.35 to 1.40 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1
Groups [1] DB Viagra/OL Viagra Week 8 to <=Week 14 vs. DB Placebo/OL Viagra Week 8 to <=Week 14
Method [2] Independent-samples t-test
P Value [3] 0.4131
Mean Difference (Net) [4] 1.61
Standard Error of the mean ± 1.958
95% Confidence Interval ( -2.26 to 5.48 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.



39.  Secondary:   Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2   [ Baseline to <Week 8 and Week 8 to <=Week 14 ]

Measure Type Secondary
Measure Title Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2
Measure Description Per-patient percentage of hardness of erections: Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.
Time Frame Baseline to <Week 8 and Week 8 to <=Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Baseline < Week 8 No text entered.
DB Placebo Baseline < Week 8 No text entered.
DB Viagra/OL Viagra Week 8 to <=Week 14 No text entered.
DB Placebo/OL Viagra Week 8 to <=Week 14 No text entered.

Measured Values
  DB Viagra Baseline < Week 8 DB Placebo Baseline < Week 8 DB Viagra/OL Viagra Week 8 to <=Week 14 DB Placebo/OL Viagra Week 8 to <=Week 14
Number of Participants Analyzed
[units: participants] 		88 74 83 68
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2
[units: percentage of occasions]
Mean ± Standard Deviation 		6.96 ± 11.858 8.72 ± 15.190 4.62 ± 10.038 2.26 ± 7.813


Statistical Analysis 1 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2
Groups [1] DB Viagra Baseline < Week 8 vs. DB Placebo Baseline < Week 8
Method [2] Independent-samples t-test
P Value [3] 0.4069
Mean Difference (Net) [4] -1.77
Standard Error of the mean ± 2.126
95% Confidence Interval ( -5.97 to 2.43 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2
Groups [1] DB Viagra/OL Viagra Week 8 to <=Week 14 vs. DB Placebo/OL Viagra Week 8 to <=Week 14
Method [2] Independent-samples t-test
P Value [3] 0.1137
Mean Difference (Net) [4] 2.37
Standard Error of the mean ± 1.489
95% Confidence Interval ( -0.57 to 5.31 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.



40.  Secondary:   Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3   [ Baseline to <Week 8 and Week 8 to <=Week 14 ]

Measure Type Secondary
Measure Title Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3
Measure Description Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.
Time Frame Baseline to <Week 8 and Week 8 to <=Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Baseline < Week 8 No text entered.
DB Placebo Baseline < Week 8 No text entered.
DB Viagra/OL Viagra Week 8 to <=Week 14 No text entered.
DB Placebo/OL Viagra Week 8 to <=Week 14 No text entered.

Measured Values
  DB Viagra Baseline < Week 8 DB Placebo Baseline < Week 8 DB Viagra/OL Viagra Week 8 to <=Week 14 DB Placebo/OL Viagra Week 8 to <=Week 14
Number of Participants Analyzed
[units: participants] 		88 74 83 68
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3
[units: percentage of occasions]
Mean ± Standard Deviation 		34.94 ± 29.253 47.17 ± 32.167 29.50 ± 28.515 30.12 ± 31.412


Statistical Analysis 1 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3
Groups [1] DB Viagra Baseline < Week 8 vs. DB Placebo Baseline < Week 8
Method [2] Independent-samples t-test
P Value [3] 0.0123
Mean Difference (Net) [4] -12.23
Standard Error of the mean ± 4.829
95% Confidence Interval ( -21.77 to -2.70 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3
Groups [1] DB Viagra/OL Viagra Week 8 to <=Week 14 vs. DB Placebo/OL Viagra Week 8 to <=Week 14
Method [2] Independent-samples t-test
P Value [3] 0.8993
Mean Difference (Net) [4] -0.62
Standard Error of the mean ± 4.883
95% Confidence Interval ( -10.27 to 9.03 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.



41.  Secondary:   Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4   [ Baseline to <Week 8 and Week 8 to <=Week 14 ]

Measure Type Secondary
Measure Title Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4
Measure Description Per-patient percentage of hardness of erections: Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.
Time Frame Baseline to <Week 8 and Week 8 to <=Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Baseline < Week 8 No text entered.
DB Placebo Baseline < Week 8 No text entered.
DB Viagra/OL Viagra Week 8 to <=Week 14 No text entered.
DB Placebo/OL Viagra Week 8 to <=Week 14 No text entered.

Measured Values
  DB Viagra Baseline < Week 8 DB Placebo Baseline < Week 8 DB Viagra/OL Viagra Week 8 to <=Week 14 DB Placebo/OL Viagra Week 8 to <=Week 14
Number of Participants Analyzed
[units: participants] 		88 74 83 68
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4
[units: percentage of occasions]
Mean ± Standard Deviation 		47.19 ± 35.293 25.16 ± 33.764 57.89 ± 35.934 62.63 ± 35.112


Statistical Analysis 1 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4
Groups [1] DB Viagra Baseline < Week 8 vs. DB Placebo Baseline < Week 8
Method [2] Independent-samples t-test
P Value [3] <0.0001
Mean Difference (Net) [4] 22.03
Standard Error of the mean ± 5.458
95% Confidence Interval ( 11.25 to 32.81 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4
Groups [1] DB Viagra/OL Viagra Week 8 to <=Week 14 vs. DB Placebo/OL Viagra Week 8 to <=Week 14
Method [2] Independent-samples t-test
P Value [3] 0.4165
Mean Difference (Net) [4] -4.74
Standard Error of the mean ± 5.818
95% Confidence Interval ( -16.24 to 6.76 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.



42.  Secondary:   Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4   [ Baseline to <Week 8 and Week 8 to <=Week 14 ]

Measure Type Secondary
Measure Title Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4
Measure Description Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.
Time Frame Baseline to <Week 8 and Week 8 to <=Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Baseline < Week 8 No text entered.
DB Placebo Baseline < Week 8 No text entered.
DB Viagra/OL Viagra Week 8 to <=Week 14 No text entered.
DB Placebo/OL Viagra Week 8 to <=Week 14 No text entered.

Measured Values
  DB Viagra Baseline < Week 8 DB Placebo Baseline < Week 8 DB Viagra/OL Viagra Week 8 to <=Week 14 DB Placebo/OL Viagra Week 8 to <=Week 14
Number of Participants Analyzed
[units: participants] 		88 74 83 68
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4
[units: percentage of occasions]
Mean ± Standard Deviation 		82.13 ± 23.476 72.33 ± 31.798 87.39 ± 22.496 92.75 ± 15.386


Statistical Analysis 1 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4
Groups [1] DB Viagra Baseline < Week 8 vs. DB Placebo Baseline < Week 8
Method [2] Independent-samples t-test
P Value [3] 0.0257
Mean Difference (Net) [4] 9.80
Standard Error of the mean ± 4.351
95% Confidence Interval ( 1.21 to 18.39 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4
Groups [1] DB Viagra/OL Viagra Week 8 to <=Week 14 vs. DB Placebo/OL Viagra Week 8 to <=Week 14
Method [2] Independent-samples t-test
P Value [3] 0.0971
Mean Difference (Net) [4] -5.36
Standard Error of the mean ± 3.209
95% Confidence Interval ( -11.70 to 0.98 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.



43.  Secondary:   Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0   [ Baseline to <Week 8 and Week 8 to <=Week 14 ]

Measure Type Secondary
Measure Title Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0
Measure Description Per-patient percentage of hardness of second erections: Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.
Time Frame Baseline to <Week 8 and Week 8 to <=Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Baseline < Week 8 No text entered.
DB Placebo Baseline < Week 8 No text entered.
DB Viagra/OL Viagra Week 8 to <=Week 14 No text entered.
DB Placebo/OL Viagra Week 8 to <=Week 14 No text entered.

Measured Values
  DB Viagra Baseline < Week 8 DB Placebo Baseline < Week 8 DB Viagra/OL Viagra Week 8 to <=Week 14 DB Placebo/OL Viagra Week 8 to <=Week 14
Number of Participants Analyzed
[units: participants] 		73 38 61 51
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0
[units: percentage of occasions]
Mean ± Standard Deviation 		0.00 ± 0.000 3.18 ± 15.052 0.13 ± 0.985 2.17 ± 14.014


Statistical Analysis 1 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0
Groups [1] DB Viagra Baseline < Week 8 vs. DB Placebo Baseline < Week 8
Method [2] Independent-samples t-test
P Value [3] 0.0726
Mean Difference (Net) [4] -3.18
Standard Error of the mean ± 1.754
95% Confidence Interval ( -6.66 to 0.30 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0
Groups [1] DB Viagra/OL Viagra Week 8 to <=Week 14 vs. DB Placebo/OL Viagra Week 8 to <=Week 14
Method [2] Independent-samples t-test
P Value [3] 0.2581
Mean Difference (Net) [4] -2.04
Standard Error of the mean ± 1.798
95% Confidence Interval ( -5.61 to 1.52 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.



44.  Secondary:   Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1   [ Baseline to <Week 8 and Week 8 to <=Week 14 ]

Measure Type Secondary
Measure Title Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1
Measure Description Per-patient percentage of hardness of second erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.
Time Frame Baseline to <Week 8 and Week 8 to <=Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Baseline < Week 8 No text entered.
DB Placebo Baseline < Week 8 No text entered.
DB Viagra/OL Viagra Week 8 to <=Week 14 No text entered.
DB Placebo/OL Viagra Week 8 to <=Week 14 No text entered.

Measured Values
  DB Viagra Baseline < Week 8 DB Placebo Baseline < Week 8 DB Viagra/OL Viagra Week 8 to <=Week 14 DB Placebo/OL Viagra Week 8 to <=Week 14
Number of Participants Analyzed
[units: participants] 		73 38 61 51
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1
[units: percentage of occasions]
Mean ± Standard Deviation 		6.43 ± 22.211 7.47 ± 22.317 1.70 ± 9.143 2.03 ± 8.638


Statistical Analysis 1 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1
Groups [1] DB Viagra Baseline < Week 8 vs. DB Placebo Baseline < Week 8
Method [2] Independent-samples t-test
P Value [3] 0.8158
Mean Difference (Net) [4] -1.04
Standard Error of the mean ± 4.450
95% Confidence Interval ( -9.86 to 7.78 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1
Groups [1] DB Viagra/OL Viagra Week 8 to <=Week 14 vs. DB Placebo/OL Viagra Week 8 to <=Week 14
Method [2] Independent-samples t-test
P Value [3] 0.8464
Mean Difference (Net) [4] -0.33
Standard Error of the mean ± 1.692
95% Confidence Interval ( -3.68 to 3.02 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.



45.  Secondary:   Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2   [ Baseline to <Week 8 and Week 8 to <=Week 14 ]

Measure Type Secondary
Measure Title Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2
Measure Description Per-patient percentage of hardness of second erections:Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.
Time Frame Baseline to <Week 8 and Week 8 to <=Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Baseline < Week 8 No text entered.
DB Placebo Baseline < Week 8 No text entered.
DB Viagra/OL Viagra Week 8 to <=Week 14 No text entered.
DB Placebo/OL Viagra Week 8 to <=Week 14 No text entered.

Measured Values
  DB Viagra Baseline < Week 8 DB Placebo Baseline < Week 8 DB Viagra/OL Viagra Week 8 to <=Week 14 DB Placebo/OL Viagra Week 8 to <=Week 14
Number of Participants Analyzed
[units: participants] 		73 38 61 51
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2
[units: percentage of occasions]
Mean ± Standard Deviation 		14.93 ± 28.145 15.27 ± 30.431 11.96 ± 24.555 12.66 ± 28.294


Statistical Analysis 1 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2
Groups [1] DB Viagra Baseline < Week 8 vs. DB Placebo Baseline < Week 8
Method [2] Independent-samples t-test
P Value [3] 0.9529
Mean Difference (Net) [4] -0.34
Standard Error of the mean ± 5.789
95% Confidence Interval ( -11.82 to 11.13 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2
Groups [1] DB Viagra/OL Viagra Week 8 to <=Week 14 vs. DB Placebo/OL Viagra Week 8 to <=Week 14
Method [2] Independent-samples t-test
P Value [3] 0.8899
Mean Difference (Net) [4] -0.69
Standard Error of the mean ± 4.994
95% Confidence Interval ( -10.59 to 9.20 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.



46.  Secondary:   Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3   [ Baseline to <Week 8 and Week 8 to <=Week 14 ]

Measure Type Secondary
Measure Title Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3
Measure Description Per-patient percentage of hardness of second erections:Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.
Time Frame Baseline to <Week 8 and Week 8 to <=Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Baseline < Week 8 No text entered.
DB Placebo Baseline < Week 8 No text entered.
DB Viagra/OL Viagra Week 8 to <=Week 14 No text entered.
DB Placebo/OL Viagra Week 8 to <=Week 14 No text entered.

Measured Values
  DB Viagra Baseline < Week 8 DB Placebo Baseline < Week 8 DB Viagra/OL Viagra Week 8 to <=Week 14 DB Placebo/OL Viagra Week 8 to <=Week 14
Number of Participants Analyzed
[units: participants] 		73 38 61 51
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3
[units: percentage of occasions]
Mean ± Standard Deviation 		37.41 ± 38.658 47.59 ± 41.025 42.97 ± 38.322 33.29 ± 31.633


Statistical Analysis 1 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3
Groups [1] DB Viagra Baseline < Week 8 vs. DB Placebo Baseline < Week 8
Method [2] Independent-samples t-test
P Value [3] 0.2001
Mean Difference (Net) [4] -10.18
Standard Error of the mean ± 7.897
95% Confidence Interval ( -25.83 to 5.47 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3
Groups [1] DB Viagra/OL Viagra Week 8 to <=Week 14 vs. DB Placebo/OL Viagra Week 8 to <=Week 14
Method [2] Independent-samples t-test
P Value [3] 0.1527
Mean Difference (Net) [4] 9.68
Standard Error of the mean ± 6.724
95% Confidence Interval ( -3.64 to 23.01 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.



47.  Secondary:   Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4   [ Baseline to <Week 8 and Week 8 to <=Week 14 ]

Measure Type Secondary
Measure Title Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4
Measure Description Per-patient percentage of hardness of second erections:Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.
Time Frame Baseline to <Week 8 and Week 8 to <=Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Baseline < Week 8 No text entered.
DB Placebo Baseline < Week 8 No text entered.
DB Viagra/OL Viagra Week 8 to <=Week 14 No text entered.
DB Placebo/OL Viagra Week 8 to <=Week 14 No text entered.

Measured Values
  DB Viagra Baseline < Week 8 DB Placebo Baseline < Week 8 DB Viagra/OL Viagra Week 8 to <=Week 14 DB Placebo/OL Viagra Week 8 to <=Week 14
Number of Participants Analyzed
[units: participants] 		73 38 61 51
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4
[units: percentage of occasions]
Mean ± Standard Deviation 		41.23 ± 41.013 26.49 ± 34.300 43.24 ± 39.891 49.86 ± 36.921


Statistical Analysis 1 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4
Groups [1] DB Viagra Baseline < Week 8 vs. DB Placebo Baseline < Week 8
Method [2] Independent-samples t-test
P Value [3] 0.0606
Mean Difference (Net) [4] 14.74
Standard Error of the mean ± 7.774
95% Confidence Interval ( -0.67 to 30.15 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4
Groups [1] DB Viagra/OL Viagra Week 8 to <=Week 14 vs. DB Placebo/OL Viagra Week 8 to <=Week 14
Method [2] Independent-samples t-test
P Value [3] 0.3678
Mean Difference (Net) [4] -6.62
Standard Error of the mean ± 7.318
95% Confidence Interval ( -21.12 to 7.88 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.



48.  Secondary:   Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4   [ Baseline to <Week 8 and Week 8 to <=Week 14 ]

Measure Type Secondary
Measure Title Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4
Measure Description Per-patient percentage of hardness of second erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.
Time Frame Baseline to <Week 8 and Week 8 to <=Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Baseline < Week 8 No text entered.
DB Placebo Baseline < Week 8 No text entered.
DB Viagra/OL Viagra Week 8 to <=Week 14 No text entered.
DB Placebo/OL Viagra Week 8 to <=Week 14 No text entered.

Measured Values
  DB Viagra Baseline < Week 8 DB Placebo Baseline < Week 8 DB Viagra/OL Viagra Week 8 to <=Week 14 DB Placebo/OL Viagra Week 8 to <=Week 14
Number of Participants Analyzed
[units: participants] 		73 38 61 51
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4
[units: percentage of occasions]
Mean ± Standard Deviation 		78.64 ± 35.395 74.08 ± 40.922 86.21 ± 27.647 83.14 ± 31.561


Statistical Analysis 1 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4
Groups [1] DB Viagra Baseline < Week 8 vs. DB Placebo Baseline < Week 8
Method [2] Independent-samples t-test
P Value [3] 0.5429
Mean Difference (Net) [4] 4.56
Standard Error of the mean ± 7.474
95% Confidence Interval ( -10.25 to 19.37 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4
Groups [1] DB Viagra/OL Viagra Week 8 to <=Week 14 vs. DB Placebo/OL Viagra Week 8 to <=Week 14
Method [2] Independent-samples t-test
P Value [3] 0.5849
Mean Difference (Net) [4] 3.07
Standard Error of the mean ± 5.595
95% Confidence Interval ( -8.02 to 14.15 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.



49.  Secondary:   Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections   [ Baseline to <Week 8 and Week 8 to <=Week 14 ]

Measure Type Secondary
Measure Title Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections
Measure Description Percentage of occasions at which second erection was achieved. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.
Time Frame Baseline to <Week 8 and Week 8 to <=Week 14  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
number of subjects in the FAS population with an observation

Reporting Groups
  Description
DB Viagra Baseline < Week 8 No text entered.
DB Placebo Baseline < Week 8 No text entered.
DB Viagra/OL Viagra Week 8 to <=Week 14 No text entered.
DB Placebo/OL Viagra Week 8 to <=Week 14 No text entered.

Measured Values
  DB Viagra Baseline < Week 8 DB Placebo Baseline < Week 8 DB Viagra/OL Viagra Week 8 to <=Week 14 DB Placebo/OL Viagra Week 8 to <=Week 14
Number of Participants Analyzed
[units: participants] 		88 74 83 68
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections
[units: percentage of occasions]
Mean ± Standard Deviation 		38.06 ± 33.287 19.20 ± 28.977 44.07 ± 38.632 39.15 ± 37.159


Statistical Analysis 1 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections
Groups [1] DB Viagra Baseline < Week 8 vs. DB Placebo Baseline < Week 8
Method [2] Independent-samples t-test
P Value [3] 0.0002
Mean Difference (Net) [4] 18.86
Standard Error of the mean ± 4.952
95% Confidence Interval ( 9.08 to 28.64 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2 for Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections
Groups [1] DB Viagra/OL Viagra Week 8 to <=Week 14 vs. DB Placebo/OL Viagra Week 8 to <=Week 14
Method [2] Independent-samples t-test
P Value [3] 0.4290
Mean Difference (Net) [4] 4.93
Standard Error of the mean ± 6.212
95% Confidence Interval ( -7.35 to 17.20 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.




  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


No publications provided


Study ID Numbers: A1481238
Study First Received: March 7, 2006
Results First Received: November 12, 2008
Last Updated: December 8, 2008
ClinicalTrials.gov Identifier: NCT00301262     History of Changes
Health Authority: Canada: Health Canada





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