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

  Participant Flow
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  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 ]
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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 ]
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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 ]
  Show Outcome Measure 9

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 ]
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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 ]
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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 ]
  Show Outcome Measure 20

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 ]
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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 ]
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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 ]
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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 ]
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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:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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


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


No publications provided


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





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