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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 on March 7, 2006.   Last Updated on December 8, 2008   History of Changes
Results First Received: November 12, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Impotence
Intervention: Drug: Viagra (Sildenafil citrate)

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

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

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

Participant Flow for 2 periods

 Period 1:   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 2:   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)   [ Time Frame: Week 8 ]
  Show Outcome Measure 1

2.  Secondary:   Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index   [ Time Frame: 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   [ Time Frame: Week 8 ]
  Show Outcome Measure 3

4.  Secondary:   Patient Reported Erectile Function Assessment (PREFA) Total Score   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: Week 8 ]
  Show Outcome Measure 9

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

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

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

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

14.  Secondary:   International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction   [ Time Frame: 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   [ Time Frame: Week 8 ]
  Show Outcome Measure 15

16.  Secondary:   Erectile Distress Scale (EDS) Total Score   [ Time Frame: 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   [ Time Frame: Week 8 ]
  Show Outcome Measure 17

18.  Secondary:   Quality of Erection Questionnaire (QEQ) Total Score   [ Time Frame: 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)   [ Time Frame: 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)   [ Time Frame: 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)   [ Time Frame: Week 8, Week 14 ]
  Show Outcome Measure 21

22.  Secondary:   Percentage of Occasions of Successful Intercourse (Event Log)   [ Time Frame: Baseline to Week 8 ]
  Show Outcome Measure 22

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

24.  Secondary:   Percentage of Occasions of Successful Intercourse (Event Log)   [ Time Frame: Week 8 to Week 14 ]
  Show Outcome Measure 24

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

26.  Secondary:   Change From Baseline to Week 8 in Analog Scales- Firmness   [ Time Frame: baseline to Week 8 ]
  Show Outcome Measure 26

27.  Secondary:   Change From Baseline to Week 8 in Analog Scales- Maintenance   [ Time Frame: baseline to Week 8 ]
  Show Outcome Measure 27

28.  Secondary:   Change From Baseline to Week 8 in Analog Scales- Reliability   [ Time Frame: baseline to Week 8 ]
  Show Outcome Measure 28

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

30.  Secondary:   Analog Scales- Firmness   [ Time Frame: Week 8, Week 14 ]
  Show Outcome Measure 30

31.  Secondary:   Analog Scales- Maintenance   [ Time Frame: Week 8, Week 14 ]
  Show Outcome Measure 31

32.  Secondary:   Analog Scales- Reliability   [ Time Frame: Week 8, Week 14 ]
  Show Outcome Measure 32

33.  Secondary:   Analog Scales- General Sexual Performance   [ Time Frame: 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   [ Time Frame: Week 8 to Week 14 ]
  Show Outcome Measure 34

35.  Secondary:   Shift in Responder Rate From Week 8 to Week 14 for GEQ2   [ Time Frame: Week 8 to Week 14 ]
  Show Outcome Measure 35

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


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





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