Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied - Study Results

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
Condition:	Impotence
Intervention:	Drug: Viagra (Sildenafil citrate)

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).

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

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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

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1. Primary:

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

Show Outcome Measure 1

2. Secondary:

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

Show Outcome Measure 2

3. Secondary:

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

Show Outcome Measure 3

4. Secondary:

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

Show Outcome Measure 4

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 ]

Show Outcome Measure 5

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 ]

Show Outcome Measure 6

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 ]

Show Outcome Measure 7

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 ]

Show Outcome Measure 8

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 ]

Hide Outcome Measure 9

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 ]

Show Outcome Measure 10

11. Secondary:

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

Show Outcome Measure 11

12. Secondary:

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

Show Outcome Measure 12

13. Secondary:

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

Show Outcome Measure 13

14. Secondary:

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

Show Outcome Measure 14

15. Secondary:

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

Show Outcome Measure 15

16. Secondary:

Erectile Distress Scale (EDS) Total Score [ Week 8, Week 14 ]

Show Outcome Measure 16

17. Secondary:

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

Show Outcome Measure 17

18. Secondary:

Quality of Erection Questionnaire (QEQ) Total Score [ Week 8, Week 14 ]

Show Outcome Measure 18

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 ]

Show Outcome Measure 19

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 ]

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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 ]

Show Outcome Measure 21

22. Secondary:

Percentage of Occasions of Successful Intercourse (Event Log) [ Baseline to Week 8 ]

Show Outcome Measure 22

23. Secondary:

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

Show Outcome Measure 23

24. Secondary:

Percentage of Occasions of Successful Intercourse (Event Log) [ Week 8 to Week 14 ]

Show Outcome Measure 24

25. Secondary:

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

Show Outcome Measure 25

26. Secondary:

Change From Baseline to Week 8 in Analog Scales- Firmness [ baseline to Week 8 ]

Show Outcome Measure 26

27. Secondary:

Change From Baseline to Week 8 in Analog Scales- Maintenance [ baseline to Week 8 ]

Show Outcome Measure 27

28. Secondary:

Change From Baseline to Week 8 in Analog Scales- Reliability [ baseline to Week 8 ]

Show Outcome Measure 28

29. Secondary:

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

Show Outcome Measure 29

30. Secondary:

Analog Scales- Firmness [ Week 8, Week 14 ]

Show Outcome Measure 30

31. Secondary:

Analog Scales- Maintenance [ Week 8, Week 14 ]

Show Outcome Measure 31

32. Secondary:

Analog Scales- Reliability [ Week 8, Week 14 ]

Show Outcome Measure 32

33. Secondary:

Analog Scales- General Sexual Performance [ Week 8, Week 14 ]

Show Outcome Measure 33

34. Secondary:

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

Show Outcome Measure 34

35. Secondary:

Shift in Responder Rate From Week 8 to Week 14 for GEQ2 [ Week 8 to Week 14 ]

Show Outcome Measure 35

36. Secondary:

Shift in Responder Rate From Week 8 to Week 14 for GEQ3 [ Week 8 to Week 14 ]

Show Outcome Measure 36

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 ]

Show Outcome Measure 37

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 ]

Show Outcome Measure 38

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 ]

Show Outcome Measure 39

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 ]

Show Outcome Measure 40

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 ]

Show Outcome Measure 41

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 ]

Show Outcome Measure 42

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 ]

Show Outcome Measure 43

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 ]

Show Outcome Measure 44

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 ]

Show Outcome Measure 45

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 ]

Show Outcome Measure 46

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 ]

Show Outcome Measure 47

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 ]

Show Outcome Measure 48

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 ]

Show Outcome Measure 49

Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.

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