Skip to main content
OpenTrials
Completed

NCT Number: NCT00301262

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

Men's quality of life (QoL) is potentially affected by mild erectile dysfunction (ED) to the same extent as it is by moderate and severe ED. This study will provide controlled clinical data measuring efficacy, QoL parameters and satisfaction changes in men with mild ED treated with Viagra versus those treated with a placebo. With an open-label extension, this study will also provide all study subjects the opportunity to receive the active drug treatment for 6 weeks.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Impotence Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men above age of majority
  • Mild erectile dysfunction (IIEF-EF 22-25) and sexual dissatisfaction (IIEF-OS 7 or less)

Exclusion criteria

  • Use of more than 4 doses of any PDE5 inhibitor in the past 12 weeks and use of any PDE5 inhibitor in the past 4 weeks
  • Subjects currently taking any other commercially available drug or non-drug treatment for ED

Treatment and study plan

Viagra (Sildenafil citrate)

Drug

Primary outcomes

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

    Time frame: Week 8

    adjusted mean : Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).

Secondary outcomes

  1. Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index

    Time frame: Week 8, Week 14

    Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).

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

    Time frame: Week 8

    adjusted mean change; PREFA Total Score: 8 = worst; 32 = best.

  3. Patient Reported Erectile Function Assessment (PREFA) Total Score

    Time frame: Week 8, Week 14

    PREFA Total Score: 8 = worst, 32 = best.

  4. 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

    adjusted mean change - Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).

  5. 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

    adjusted mean change - Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).

  6. 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

    adjusted mean change - Possible total scores for IIEF-SD range from 2 (worst) to 10 (best).

  7. 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

    adjusted mean - Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).

  8. 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

    adjusted mean change - Possible total scores for IIEF-OS range from 2 (worst) to 10 (best).

  9. International Index of Erectile Function (IIEF) Domain Scores- Erectile Function

    Time frame: Week 8, Week 14

    Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).

  10. International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function

    Time frame: Week 8, Week 14

    Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).

  11. International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire

    Time frame: Week 8, Week 14

    Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).

  12. International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction

    Time frame: Week 8, Week 14

    Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).

  13. International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction

    Time frame: Week 8, Week 14

    Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).

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

    Time frame: Week 8

    adjusted mean change - Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.

  15. Erectile Distress Scale (EDS) Total Score

    Time frame: Week 8, Week 14

    Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.

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

    Time frame: Week 8

    adjusted mean change - QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).

  17. Quality of Erection Questionnaire (QEQ) Total Score

    Time frame: Week 8, Week 14

    QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).

  18. 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

    GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections?Responder was defined as answering "Yes". % of responders/non-responders was calculated based on subjects who attempted intercourse.

  19. 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

    GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering "Yes". % of responders/non-responders was calculated based on subjects who attempted intercourse.

  20. 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

    GEQ 3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Resp. was defined as answering almost always or always, most times, or sometimes, and non-resp was defined as answering a few times or almost never or never.

  21. Percentage of Occasions of Successful Intercourse (Event Log)

    Time frame: Baseline to Week 8

    Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

  22. Percentage of Occasions of Ejaculation and/or Orgasm (Event Log)

    Time frame: Baseline to Week 8

    Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

  23. Percentage of Occasions of Successful Intercourse (Event Log)

    Time frame: Week 8 to Week 14

    Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

  24. Percentage of Occasions of Ejaculation and/or Orgasm Event Log

    Time frame: Week 8 to Week 14

    Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

  25. Change From Baseline to Week 8 in Analog Scales- Firmness

    Time frame: baseline to Week 8

    mean change - scale of 0 (worst) to 10 (best).

  26. Change From Baseline to Week 8 in Analog Scales- Maintenance

    Time frame: baseline to Week 8

    mean change - scale of 0 (worst) to 10 (best).

  27. Change From Baseline to Week 8 in Analog Scales- Reliability

    Time frame: baseline to Week 8

    mean change - scale of 0 (worst) to 10 (best).

  28. Change From Baseline to Week 8 in Analog Scales- General Sexual Performance

    Time frame: baseline to week 8

    mean change - scale of 0 (worst) to 10 (best)

  29. Analog Scales- Firmness

    Time frame: Week 8, Week 14

    mean - scale of 0 (worst) to 10 (best)

  30. Analog Scales- Maintenance

    Time frame: Week 8, Week 14

    mean - scale of 0 (worst) to 10 (best)

  31. Analog Scales- Reliability

    Time frame: Week 8, Week 14

    mean - scale of 0 (worst) to 10 (best)

  32. Analog Scales- General Sexual Performance

    Time frame: Week 8, Week 14

    mean - scale of 0 (worst) to 10 (best)

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

    Time frame: Week 8 to Week 14

    GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections? Responder was defined as answering Yes to GEQ 1.

  34. Shift in Responder Rate From Week 8 to Week 14 for GEQ2

    Time frame: Week 8 to Week 14

    GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering Yes to GEQ 2.

  35. Shift in Responder Rate From Week 8 to Week 14 for GEQ3

    Time frame: Week 8 to Week 14

    GEQ3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Responder = almost always or always, most times, or sometimes. Non-responder = a few times (much less than half the time) or almost never or never.

  36. 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

    Per-patient percentage of hardness of erections:Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

  37. 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

    Per-patient percentage of hardness of erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

  38. 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

    Per-patient percentage of hardness of erections: Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

  39. 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

    Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

  40. 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

    Per-patient percentage of hardness of erections: Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

  41. 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

    Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

  42. 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

    Per-patient percentage of hardness of second erections: Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

  43. 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

    Per-patient percentage of hardness of second erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

  44. 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

    Per-patient percentage of hardness of second erections:Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

  45. 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

    Per-patient percentage of hardness of second erections:Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

  46. 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

    Per-patient percentage of hardness of second erections:Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

  47. 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

    Per-patient percentage of hardness of second erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

  48. 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

    Percentage of occasions at which second erection was achieved. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Collaborators

  • Pfizer

Registry information

Official study title

A Multi-Center, Parallel Group, Flexible Dose Trial With A Double-Blind, Randomized, Placebo-Controlled Phase Followed By An Open-Label Phase To Assess The Impact Of Viagra On The Sexual Satisfaction Of Men With Mild Erectile Dysfunction

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Mar 10, 2006
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.