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A Study in Erectile Dysfunction

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ClinicalTrials.gov Identifier: NCT01130532
Recruitment Status : Completed
First Posted : May 26, 2010
Results First Posted : January 4, 2013
Last Update Posted : January 4, 2013
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Erectile Dysfunction
Interventions Drug: Tadalafil
Drug: Placebo
Enrollment 623

Recruitment Details  
Pre-assignment Details This study consisted of 4 periods. Period I was a 4-week, as needed, run-in period. Period II was a 4-week, non-drug, wash-out period. Period III was a 12-week (Weeks 0-12), double-blind treatment. Period IV was a 4-week (Weeks 13-16), open-label treatment extension. Only participants completing Period III were eligible to continue into Period IV.
Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil 5 mg Tadalafil Placebo 5 mg Tadalafil Open-Label Extension
Hide Arm/Group Description 2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period. 5.0 mg Tadalafil for 12 weeks during double-blind treatment period. Placebo for 12 weeks during double-blind treatment period. 5 mg Tadalafil for 4 weeks during open-label treatment extension period.
Period Title: Period III (Weeks 0-12)
Started 207 207 209 0
Received at Least 1 Dose of Study Drug 205 205 207 0
Completed 186 189 190 0
Not Completed 21 18 19 0
Reason Not Completed
Adverse Event             3             3             2             0
Entry Criteria Not Met             4             2             4             0
Lack of Efficacy             2             0             1             0
Lost to Follow-up             2             2             3             0
Protocol Violation             0             0             1             0
Sponsor Decision             3             4             2             0
Withdrawal by Subject             7             7             6             0
Period Title: Period IV (Weeks 13-16)
Started 0 0 0 562 [1]
Received at Least 1 Dose of Study Drug 0 0 0 546
Completed 0 0 0 552
Not Completed 0 0 0 10
Reason Not Completed
Adverse Event             0             0             0             1
Entry Criteria Not Met             0             0             0             1
Lost to Follow-up             0             0             0             5
Withdrawal by Subject             0             0             0             3
[1]
Three participants who completed Period III chose not to continue into Period IV.
Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil 5 mg Tadalafil Placebo Total
Hide Arm/Group Description 2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period. 5.0 mg Tadalafil for 12 weeks during double-blind treatment period. Placebo for 12 weeks during double-blind treatment period. Total of all reporting groups
Overall Number of Baseline Participants 207 207 209 623
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 207 participants 207 participants 209 participants 623 participants
57.3  (10.68) 58.1  (10.36) 57.6  (10.17) 57.6  (10.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 207 participants 207 participants 209 participants 623 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
207
 100.0%
207
 100.0%
209
 100.0%
623
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 207 participants 207 participants 209 participants 623 participants
Hispanic or Latino
8
   3.9%
10
   4.8%
9
   4.3%
27
   4.3%
Not Hispanic or Latino
199
  96.1%
197
  95.2%
200
  95.7%
596
  95.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 207 participants 207 participants 209 participants 623 participants
American Indian or Alaska Native
0
   0.0%
2
   1.0%
0
   0.0%
2
   0.3%
Asian
2
   1.0%
2
   1.0%
4
   1.9%
8
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   0.5%
1
   0.2%
Black or African American
29
  14.0%
24
  11.6%
35
  16.7%
88
  14.1%
White
173
  83.6%
177
  85.5%
167
  79.9%
517
  83.0%
More than one race
3
   1.4%
1
   0.5%
2
   1.0%
6
   1.0%
Unknown or Not Reported
0
   0.0%
1
   0.5%
0
   0.0%
1
   0.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 207 participants 207 participants 209 participants 623 participants
United States 199 195 191 585
Canada 8 11 18 37
Puerto Rico 0 1 0 1
1.Primary Outcome
Title Percentage of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint (Double-Blind Treatment Period)
Hide Description Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of double-blind treatment period (Period III).
Time Frame Baseline through 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-EF measurement, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period III) 5 mg Tadalafil (Period III) Placebo (Period III)
Hide Arm/Group Description:
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
Placebo for 12 weeks during double-blind treatment period (Period III).
Overall Number of Participants Analyzed 194 197 199
Measure Type: Number
Unit of Measure: percentage of participants
38.7 39.6 12.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score
Hide Description Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
Time Frame Baseline, 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-EF measurement, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period III) 5 mg Tadalafil (Period III) Placebo (Period III)
Hide Arm/Group Description:
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
Placebo for 12 weeks during double-blind treatment period (Period III).
Overall Number of Participants Analyzed 194 197 199
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
7.9  (0.49) 8.1  (0.49) 1.8  (0.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 6.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.69
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 6.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.68
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Intercourse Satisfaction (IIEF-IS) Domain Score
Hide Description Self-reported intercourse satisfaction over the past 4 weeks. IIEF-IS is the sum of Questions 6, 7 and 8 of the IIEF. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
Time Frame Baseline, 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-IS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period III) 5 mg Tadalafil (Period III) Placebo (Period III)
Hide Arm/Group Description:
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
Placebo for 12 weeks during double-blind treatment period (Period III).
Overall Number of Participants Analyzed 194 197 198
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.8  (0.21) 2.6  (0.21) 0.6  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.29
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.29
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Overall Satisfaction (IIEF-OS) Domain Score
Hide Description Self-reported overall satisfaction over the past 4 weeks. IIEF-OS is the sum of Questions 13 and 14; each question scored as 1 (low/no satisfaction) through 5 (high satisfaction) with total subscore for the 2 questions of 2 to 10. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
Time Frame Baseline, 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-OS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period III) 5 mg Tadalafil (Period III) Placebo (Period III)
Hide Arm/Group Description:
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
Placebo for 12 weeks during double-blind treatment period (Period III).
Overall Number of Participants Analyzed 194 197 199
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.4  (0.16) 2.4  (0.16) 0.6  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.23
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.22
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to 12-Week in Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 1-5
Hide Description Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Questions 1-5. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
Time Frame Baseline, 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline SEP Questions assessment, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period III) 5 mg Tadalafil (Period III) Placebo (Period III)
Hide Arm/Group Description:
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
Placebo for 12 weeks during double-blind treatment period (Period III).
Overall Number of Participants Analyzed 193 195 196
Least Squares Mean (Standard Error)
Unit of Measure: percentage of "yes" responses
Question 1: Able to Achieve Erection 12.2  (1.63) 11.4  (1.62) 1.8  (1.62)
Question 2: Able to Insert 26.2  (2.25) 26.1  (2.23) 6.9  (2.23)
Question 3: Successful Intercourse 37.3  (2.52) 39.4  (2.50) 12.6  (2.51)
Question 4: Satisfied with Hardness 44.2  (2.73) 42.8  (2.70) 11.5  (2.71)
Question 5: Overall Satisfaction with Experience 43.6  (2.70) 41.2  (2.68) 10.6  (2.68)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Question 1. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 10.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.28
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Question 1. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 9.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.26
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Question 2. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 19.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.14
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Question 2. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 19.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.12
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Question 3. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 24.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.53
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Question 3. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 26.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.50
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Question 4. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 32.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.82
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Question 4. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 31.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.79
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Question 5. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 33.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.78
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Question 5. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 30.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.75
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Patient
Hide Description The TSS measured participant satisfaction with treatment based on a 13-item questionnaire. The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
Time Frame Baseline, 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline TSS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period III) 5 mg Tadalafil (Period III) Placebo (Period III)
Hide Arm/Group Description:
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
Placebo for 12 weeks during double-blind treatment period (Period III).
Overall Number of Participants Analyzed 189 189 192
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Confidence to complete sexual activity 27.0  (1.78) 29.2  (1.78) 3.8  (1.77)
Ease of erection 24.0  (1.69) 24.7  (1.69) 4.1  (1.68)
Pleasure from sexual activity 22.6  (1.58) 22.7  (1.58) 3.3  (1.57)
Erectile function satisfaction 31.0  (1.82) 33.6  (1.81) 4.9  (1.81)
Satisfaction with orgasm 25.6  (1.90) 26.3  (1.89) 6.2  (1.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 23.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.49
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 25.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.48
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 19.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.36
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 20.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.35
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 19.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.21
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 19.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.20
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 26.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.54
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 28.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.53
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 19.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.65
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 20.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.64
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Treatment Satisfaction Scale (TSS) - Patient Satisfaction With Medication Score at Week 12 Endpoint
Hide Description The TSS - patient satisfaction with medication measured participant satisfaction with treatment based on a 13-item questionnaire. The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Satisfaction with medication was analyzed using analysis of covariance (ANOVA). The model included factors of study, treatment group, and pooled site within study.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline participant's satisfaction with medication measurement, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period III) 5 mg Tadalafil (Period III) Placebo (Period III)
Hide Arm/Group Description:
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
Placebo for 12 weeks during double-blind treatment period (Period III).
Overall Number of Participants Analyzed 189 189 192
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
53.7  (1.98) 55.9  (1.98) 24.8  (1.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 28.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.77
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 31.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.76
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function (IIEF) Question 15 (Sexual Confidence)
Hide Description Self-reported erectile function over the past 4 weeks. Question 15, confidence in the ability to get an erection, is scored from 1 (very low confidence) to 5 (very high confidence). Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
Time Frame Baseline, 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF question 15 (Sexual Confidence) assessment, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period III) 5 mg Tadalafil (Period III) Placebo (Period III)
Hide Arm/Group Description:
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
Placebo for 12 weeks during double-blind treatment period (Period III).
Overall Number of Participants Analyzed 194 197 199
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.2  (0.08) 1.3  (0.08) 0.3  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Partner
Hide Description The TSS measured participant's partner satisfaction with treatment based on a 13-item questionnaire. The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
Time Frame Baseline, 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline partner's TSS measurement, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period III) 5 mg Tadalafil (Period III) Placebo (Period III)
Hide Arm/Group Description:
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
Placebo for 12 weeks during double-blind treatment period (Period III).
Overall Number of Participants Analyzed 184 186 187
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Confidence to complete sexual activity 23.7  (2.01) 27.2  (1.99) 2.0  (1.99)
Ease of erection 23.1  (1.76) 25.3  (1.75) 0.7  (1.75)
Pleasure from sexual activity 18.2  (1.69) 18.5  (1.68) 1.3  (1.68)
Erectile function satisfaction 28.6  (1.84) 28.5  (1.83) 3.4  (1.83)
Satisfaction with orgasm 18.7  (2.06) 21.0  (2.05) 3.6  (2.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 21.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.81
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 25.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.78
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 22.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.46
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 24.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.44
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 16.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.37
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 17.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.35
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 25.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.57
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 25.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.56
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 15.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.88
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 17.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.86
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Treatment Satisfaction Scale (TSS) – Partner Satisfaction With Medication Score at Week 12 Endpoint
Hide Description The TSS - partner satisfaction with medication measured participant's partner satisfaction with treatment based on a 13-item questionnaire. The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Satisfaction with medication was analyzed using analysis of covariance (ANOVA). The model included factors of study, treatment group, and pooled site within study.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline partner's satisfaction with medication measurement, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period III) 5 mg Tadalafil (Period III) Placebo (Period III)
Hide Arm/Group Description:
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
Placebo for 12 weeks during double-blind treatment period (Period III).
Overall Number of Participants Analyzed 184 186 187
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
52.5  (1.97) 55.7  (1.96) 27.5  (1.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 25.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.76
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 28.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.74
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants Having International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 From 12 to 16 Weeks
Hide Description Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of open-label extension treatment period (Period IV).
Time Frame 12 weeks through 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were entered the open-label treatment, received at least 1 dose of study drug during open-label treatment, had Week 12 and at least 1 IIEF-EF measurement during open-label treatment, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period IV) 5 mg Tadalafil (Period IV) Placebo (Period IV)
Hide Arm/Group Description:
5.0 milligram (mg) Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
Overall Number of Participants Analyzed 178 179 183
Measure Type: Number
Unit of Measure: percentage of participants
54.5 59.8 62.8
12.Secondary Outcome
Title Change From 12 Weeks to 16 Weeks in Participant's International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score
Hide Description Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function.
Time Frame 12 weeks and 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were entered the open-label treatment, received at least 1 dose of study drug during open-label treatment, had Week 12 and at least 1 IIEF-EF measurement during open-label treatment, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period IV) 5 mg Tadalafil (Period IV) Placebo (Period IV)
Hide Arm/Group Description:
5.0 milligram (mg) Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
Overall Number of Participants Analyzed 178 179 183
Mean (Standard Deviation)
Unit of Measure: units on a scale
End of Week 12 22.4  (6.71) 22.5  (7.07) 16.0  (7.39)
End of Week 16 24.1  (6.44) 24.2  (6.46) 24.4  (6.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period IV)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period IV)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (Period IV)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method Paired t-test
Comments [Not Specified]
13.Secondary Outcome
Title Change From Week 12 to Week 16 Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 3
Hide Description Assessed the percentage of Yes responses to the SEP diary Question 3 "Did your erection last long enough for you to have successful intercourse?" from Week 12 (end of double-Blind treatment) to Week 16 (end of open-label treatment).
Time Frame 12 weeks and 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were entered the open-label treatment, received at least 1 dose of study drug during open-label treatment, had Week 12 and at least 1 SEP diary Question 3 measurement during open-label treatment, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period IV) 5 mg Tadalafil (Period IV) Placebo (Period IV)
Hide Arm/Group Description:
5.0 milligram (mg) Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
Overall Number of Participants Analyzed 176 177 181
Mean (Standard Deviation)
Unit of Measure: percentage of "yes" responses
End of Week 12 68.3  (38.25) 69.0  (37.88) 43.1  (39.03)
End of Week 16 75.0  (34.49) 75.5  (34.89) 80.0  (34.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period IV)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period IV)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (Period IV)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
Method Paired t-test
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil 5 mg Tadalafil Placebo 5 mg Tadalafil Open-Label Extension
Hide Arm/Group Description 2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period. 5.0 mg Tadalafil for 12 weeks during double-blind treatment period. Placebo for 12 weeks during double-blind treatment period. 5 mg Tadalafil for 4 weeks during open-label treatment extension period.
All-Cause Mortality
2.5 mg Titrated to 5 mg Tadalafil 5 mg Tadalafil Placebo 5 mg Tadalafil Open-Label Extension
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
2.5 mg Titrated to 5 mg Tadalafil 5 mg Tadalafil Placebo 5 mg Tadalafil Open-Label Extension
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/205 (0.49%)      1/205 (0.49%)      1/207 (0.48%)      3/546 (0.55%)    
Gastrointestinal disorders         
Small intestinal obstruction  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
General disorders         
Chest discomfort  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Hepatobiliary disorders         
Cholecystitis acute  1  0/205 (0.00%)  0 0/205 (0.00%)  0 0/207 (0.00%)  0 1/546 (0.18%)  1
Infections and infestations         
Meningitis viral  1  0/205 (0.00%)  0 0/205 (0.00%)  0 0/207 (0.00%)  0 1/546 (0.18%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Prostate cancer  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Nervous system disorders         
Syncope  1  0/205 (0.00%)  0 0/205 (0.00%)  0 0/207 (0.00%)  0 1/546 (0.18%)  1
Respiratory, thoracic and mediastinal disorders         
Dyspnoea exertional  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
2.5 mg Titrated to 5 mg Tadalafil 5 mg Tadalafil Placebo 5 mg Tadalafil Open-Label Extension
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   46/205 (22.44%)      68/205 (33.17%)      50/207 (24.15%)      23/546 (4.21%)    
Blood and lymphatic system disorders         
Anaemia  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 1/546 (0.18%)  1
Cardiac disorders         
Palpitations  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Supraventricular tachycardia  1  0/205 (0.00%)  0 0/205 (0.00%)  0 0/207 (0.00%)  0 1/546 (0.18%)  1
Tachycardia  1  0/205 (0.00%)  0 0/205 (0.00%)  0 0/207 (0.00%)  0 1/546 (0.18%)  1
Ear and labyrinth disorders         
Hearing impaired  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Motion sickness  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Vertigo  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Vertigo positional  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Eye disorders         
Cataract  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Ocular hyperaemia  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Vision blurred  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 1/546 (0.18%)  1
Vitreous floaters  1  0/205 (0.00%)  0 0/205 (0.00%)  0 0/207 (0.00%)  0 1/546 (0.18%)  1
Gastrointestinal disorders         
Abdominal discomfort  1  0/205 (0.00%)  0 0/205 (0.00%)  0 0/207 (0.00%)  0 1/546 (0.18%)  1
Abdominal hernia  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Abdominal pain lower  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Abdominal pain upper  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Dental caries  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Diarrhoea  1  2/205 (0.98%)  2 3/205 (1.46%)  3 3/207 (1.45%)  3 0/546 (0.00%)  0
Dry mouth  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Dyspepsia  1  2/205 (0.98%)  2 6/205 (2.93%)  6 1/207 (0.48%)  1 0/546 (0.00%)  0
Gastrooesophageal reflux disease  1  0/205 (0.00%)  0 2/205 (0.98%)  2 0/207 (0.00%)  0 0/546 (0.00%)  0
Haematochezia  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Nausea  1  0/205 (0.00%)  0 1/205 (0.49%)  1 2/207 (0.97%)  2 0/546 (0.00%)  0
Oesophageal ulcer  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Retching  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Toothache  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
General disorders         
Chest pain  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Fatigue  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Hernia  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Impaired healing  1  0/205 (0.00%)  0 0/205 (0.00%)  0 0/207 (0.00%)  0 1/546 (0.18%)  1
Influenza like illness  1  0/205 (0.00%)  0 0/205 (0.00%)  0 0/207 (0.00%)  0 1/546 (0.18%)  1
Irritability  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Non-cardiac chest pain  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Oedema peripheral  1  2/205 (0.98%)  2 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Pyrexia  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Suprapubic pain  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Immune system disorders         
Seasonal allergy  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Infections and infestations         
Abdominal abscess  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Acute tonsillitis  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Bronchitis  1  3/205 (1.46%)  3 2/205 (0.98%)  2 0/207 (0.00%)  0 0/546 (0.00%)  0
Cellulitis  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Device related infection  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Furuncle  1  0/205 (0.00%)  0 0/205 (0.00%)  0 0/207 (0.00%)  0 1/546 (0.18%)  1
Gastroenteritis  1  0/205 (0.00%)  0 1/205 (0.49%)  1 1/207 (0.48%)  1 0/546 (0.00%)  0
Gastroenteritis viral  1  1/205 (0.49%)  1 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Infected bites  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Influenza  1  0/205 (0.00%)  0 0/205 (0.00%)  0 0/207 (0.00%)  0 1/546 (0.18%)  1
Laryngitis  1  1/205 (0.49%)  1 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Nasopharyngitis  1  2/205 (0.98%)  2 3/205 (1.46%)  3 1/207 (0.48%)  1 0/546 (0.00%)  0
Otitis externa  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Otitis media  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Perirectal abscess  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Pharyngitis streptococcal  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Pneumonia  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Pneumonia bacterial  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Pneumonia primary atypical  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Prostate infection  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Sinusitis  1  1/205 (0.49%)  1 3/205 (1.46%)  3 1/207 (0.48%)  1 2/546 (0.37%)  2
Tonsillitis  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Tooth abscess  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Upper respiratory tract infection  1  3/205 (1.46%)  3 2/205 (0.98%)  2 3/207 (1.45%)  3 0/546 (0.00%)  0
Viral infection  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Wound infection  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Injury, poisoning and procedural complications         
Arthropod bite  1  1/205 (0.49%)  1 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Arthropod sting  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Contusion  1  0/205 (0.00%)  0 2/205 (0.98%)  2 0/207 (0.00%)  0 0/546 (0.00%)  0
Craniocerebral injury  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Excoriation  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Exposure via father  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Foot fracture  1  0/205 (0.00%)  0 2/205 (0.98%)  2 0/207 (0.00%)  0 0/546 (0.00%)  0
Laceration  1  0/205 (0.00%)  0 1/205 (0.49%)  1 1/207 (0.48%)  1 0/546 (0.00%)  0
Ligament sprain  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Limb injury  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Muscle strain  1  0/205 (0.00%)  0 0/205 (0.00%)  0 2/207 (0.97%)  2 0/546 (0.00%)  0
Overdose  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 1/546 (0.18%)  1
Procedural pain  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Rib fracture  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Investigations         
Cytology abnormal  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Heart rate increased  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Prostatic specific antigen increased  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Weight increased  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Metabolism and nutrition disorders         
Gout  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Hypercholesterolaemia  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Hyperkalaemia  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Hypokalaemia  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/205 (0.00%)  0 0/205 (0.00%)  0 3/207 (1.45%)  3 0/546 (0.00%)  0
Back pain  1  3/205 (1.46%)  3 6/205 (2.93%)  6 1/207 (0.48%)  1 2/546 (0.37%)  2
Exostosis  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Groin pain  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Joint hyperextension  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Metatarsalgia  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Muscle spasms  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Musculoskeletal chest pain  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Musculoskeletal discomfort  1  0/205 (0.00%)  0 2/205 (0.98%)  2 0/207 (0.00%)  0 0/546 (0.00%)  0
Myalgia  1  1/205 (0.49%)  1 1/205 (0.49%)  1 1/207 (0.48%)  1 1/546 (0.18%)  1
Pain in extremity  1  1/205 (0.49%)  1 3/205 (1.46%)  3 0/207 (0.00%)  0 0/546 (0.00%)  0
Spinal osteoarthritis  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Tendonitis  1  0/205 (0.00%)  0 2/205 (0.98%)  2 1/207 (0.48%)  1 0/546 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Prostate cancer  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Skin papilloma  1  0/205 (0.00%)  0 1/205 (0.49%)  3 0/207 (0.00%)  0 0/546 (0.00%)  0
Squamous cell carcinoma of skin  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Nervous system disorders         
Balance disorder  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Dizziness  1  1/205 (0.49%)  1 3/205 (1.46%)  3 1/207 (0.48%)  1 1/546 (0.18%)  2
Headache  1  4/205 (1.95%)  4 9/205 (4.39%)  9 7/207 (3.38%)  8 4/546 (0.73%)  4
Nerve compression  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Paraesthesia  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Radiculopathy  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Restless legs syndrome  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Sciatica  1  0/205 (0.00%)  0 0/205 (0.00%)  0 0/207 (0.00%)  0 1/546 (0.18%)  1
Sensory disturbance  1  0/205 (0.00%)  0 0/205 (0.00%)  0 0/207 (0.00%)  0 1/546 (0.18%)  1
Sinus headache  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Syncope  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Psychiatric disorders         
Abnormal dreams  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Anxiety  1  0/205 (0.00%)  0 0/205 (0.00%)  0 2/207 (0.97%)  2 0/546 (0.00%)  0
Depression  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Insomnia  1  0/205 (0.00%)  0 0/205 (0.00%)  0 0/207 (0.00%)  0 1/546 (0.18%)  1
Libido decreased  1  0/205 (0.00%)  0 0/205 (0.00%)  0 2/207 (0.97%)  2 0/546 (0.00%)  0
Nightmare  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Renal and urinary disorders         
Chromaturia  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Dysuria  1  1/205 (0.49%)  1 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Haematuria  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Reproductive system and breast disorders         
Benign prostatic hyperplasia  1  0/205 (0.00%)  0 1/205 (0.49%)  1 1/207 (0.48%)  1 0/546 (0.00%)  0
Genital rash  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Nipple pain  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Organic erectile dysfunction  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Paraesthesia of genital male  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Penile discharge  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Spermatocele  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Testicular pain  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Asthma  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Chronic obstructive pulmonary disease  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Cough  1  2/205 (0.98%)  2 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Dyspnoea  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Epistaxis  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Nasal congestion  1  2/205 (0.98%)  2 0/205 (0.00%)  0 3/207 (1.45%)  3 0/546 (0.00%)  0
Oropharyngeal pain  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Pharyngeal inflammation  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Respiratory tract congestion  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Sinus congestion  1  1/205 (0.49%)  1 1/205 (0.49%)  1 1/207 (0.48%)  1 1/546 (0.18%)  1
Upper-airway cough syndrome  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Skin and subcutaneous tissue disorders         
Dermatitis  1  0/205 (0.00%)  0 0/205 (0.00%)  0 0/207 (0.00%)  0 1/546 (0.18%)  1
Dermatitis allergic  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Eczema  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Hyperhidrosis  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Night sweats  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Pruritus  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Psoriasis  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Rash  1  0/205 (0.00%)  0 0/205 (0.00%)  0 0/207 (0.00%)  0 1/546 (0.18%)  1
Rosacea  1  0/205 (0.00%)  0 0/205 (0.00%)  0 0/207 (0.00%)  0 1/546 (0.18%)  1
Surgical and medical procedures         
Anal polypectomy  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Blepharoplasty  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Cataract operation  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  2 0/546 (0.00%)  0
Dental care  1  0/205 (0.00%)  0 0/205 (0.00%)  0 0/207 (0.00%)  0 1/546 (0.18%)  1
Endodontic procedure  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Knee operation  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Medical device removal  1  0/205 (0.00%)  0 1/205 (0.49%)  1 0/207 (0.00%)  0 0/546 (0.00%)  0
Tooth extraction  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Tooth repair  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Umbilical hernia repair  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Vasectomy  1  1/205 (0.49%)  1 0/205 (0.00%)  0 0/207 (0.00%)  0 0/546 (0.00%)  0
Vascular disorders         
Flushing  1  1/205 (0.49%)  1 3/205 (1.46%)  3 0/207 (0.00%)  0 0/546 (0.00%)  0
Hypertension  1  2/205 (0.98%)  2 2/205 (0.98%)  2 3/207 (1.45%)  3 1/546 (0.18%)  1
Hypotension  1  0/205 (0.00%)  0 1/205 (0.49%)  1 1/207 (0.48%)  1 0/546 (0.00%)  0
Orthostatic hypertension  1  0/205 (0.00%)  0 0/205 (0.00%)  0 1/207 (0.48%)  1 0/546 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
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.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01130532     History of Changes
Other Study ID Numbers: 13461
H6D-US-LVIP ( Other Identifier: Eli Lilly and Company )
First Submitted: May 24, 2010
First Posted: May 26, 2010
Results First Submitted: December 3, 2012
Results First Posted: January 4, 2013
Last Update Posted: January 4, 2013