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NCT Number: NCT00468650

A Multicenter, Open Label, To Evaluate The Efficacy And Satisfaction Of Patrex® In Men With Erectile Dysfunction.

A multicenter open label study to assess the efficacy of sildenafil rapid dose titration to 100 mg in men with erectile dysfunction, based on the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) questionnaire.

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Key information

Conditions

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, México, D.F., Mexico

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Documented Clinical diagnosis of Erectile Dysfunction (ED) by International Index of Erectile Function (IIEF) Erectile Function (EF) Domain score less than or equal to 25.
  • Subjects must be in a stable relationship

Exclusion criteria

  • Subject with resting sitting hypotension (BP <90/50 mmHg) or hypertension (BP>170/110 mmHg) and orthostatic hypotension.
  • Subjects receiving any PDE (Phosphodiesterase)-5 inhibitors within 4 weeks prior to the date of screening.
  • Subjects with severe hepatic impairment, a known history of retinitis pigmentare.
  • Subjects with significant cardiovascular disease in the last 3 months (per medical history.

Treatment and study plan

sildenafil citrate

Drug

Tablets, 50mg and 100mg , Medication will be taken orally with a glass of water approximately one hour (30 min to 4 hours) before sexual activity. Subjects are to take one dose in any calendar day.Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil 100 mg PRN for the following four weeks.

Primary outcomes

  1. International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Baseline to Week 6 Last Observation Carried Forward (LOCF)

    Time frame: Week 6 LOCF

    IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.

Secondary outcomes

  1. International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score - Change From Baseline at Weeks 2, 4 and 6

    Time frame: Week 2, Week 4 and Week 6

    IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.

  2. International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Week 2

    Time frame: Week 4 and Week 6

    IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.

  3. International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Baseline

    Time frame: Week 2, Week 4 and Week 6

    IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is orgasmic function. IIEF Orgasmic Function Domain was sum of scores for Questions 9 and 10 from the IIEF. Score range: 0 to 5; total 0 to 10. Higher score indicates better outcome.

  4. International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Week 2

    Time frame: Week 4 and Week 6

    IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is orgasmic function. IIEF Orgasmic Function Domain was sum of scores for Questions 9 and 10 from the IIEF. Score range: 0 to 5; total 0 to 10. Higher score indicates better outcome.

  5. International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Baseline

    Time frame: Week 2, Week 4 and Week 6

    IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one of which is sexual desire. IIEF Sexual Desire Domain was sum of scores for Questions 11 and 12 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.

  6. International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Week 2

    Time frame: Week 4 and Week 6

    IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one of which is sexual desire. IIEF Sexual Desire Domain was sum of scores for Questions 11 and 12 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.

  7. International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Baseline

    Time frame: Week 2, Week 4, and Week 6

    IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is intercourse satisfaction. IIEF Intercourse Satisfaction Domain: sum of scores for Questions 6, 7 and 8 from IIEF. Score range: 0 to 5; total 0 to 15. Higher score indicates better outcome.

  8. International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Week 2

    Time frame: Week 4 and Week 6

    IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is intercourse satisfaction. IIEF Intercourse Satisfaction Domain: sum of scores for Questions 6, 7 and 8 from IIEF. Score range: 0 to 5; total 0 to 15. Higher score indicates better outcome.

  9. International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Baseline

    Time frame: Week 2, Week 4 and Week 6

    IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is overall satisfaction. IIEF Overall Satisfaction Domain was sum of scores for Questions 13 and 14 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.

  10. International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Week 2

    Time frame: Week 4 and Week 6

    IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is overall satisfaction. IIEF Overall Satisfaction Domain was sum of scores for Questions 13 and 14 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.

  11. Quality of Erection Questionnaire (QEQ): Total Score - Change From Baseline

    Time frame: Week 2, Week 4, and Week 6

    QEQ is a self-administered scale used to assess erection hardness and overall quality of erections. The QEQ total score is defined as the sum of the scores from QEQ Questions 1-6. Score range: 1 to 5. Higher score indicates better outcome. Raw QEQ score ranges from 6-30 and is transformed onto a 0-100 scale.

  12. Quality of Erection Questionnaire (QEQ): Total Score- Change From Week 2

    Time frame: Week 4 and Week 6

    QEQ is a self-administered scale used to assess erection hardness and overall quality of erections. The QEQ total score is defined as the sum of the scores from QEQ Questions 1-6. Score range: 1 to 5. Higher score indicates better outcome. Raw QEQ score ranges from 6-30 and is transformed onto a 0-100 scale.

  13. Sexual Experience Questionnaire (Sex-Q): Erection Domain - Change From Baseline

    Time frame: Week 2, Week 4 and Week 6

    Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Erection domain: sum of scores for Questions 1, 2, 3, 4, 5 and 6 from the Sex-Q. Score range: 1 to 5; total 6 to 30. Higher score indicates better outcome.

  14. Sexual Experience Questionnaire (Sex-Q): Erection Domain- Change From Week 2

    Time frame: Week 4 and Week 6

    Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Erection domain: sum of scores for Questions 1, 2, 3, 4, 5 and 6 from the Sex-Q. Score range: 1 to 5; total 6 to 30. Higher score indicates better outcome.

  15. Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Baseline

    Time frame: Week 2, Week 4, and Week 6

    Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions (q). Sex-Q Satisfaction domain:sum of scores for q 10, 11, 12, 13, 14 and 15 from Sex-Q. Score range:1 to 5; total 6 to 30. Higher score indicates better outcome

  16. Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Week 2

    Time frame: Week 4 and Week 6

    Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions (q). Sex-Q Satisfaction domain:sum of scores for q 10, 11, 12, 13, 14 and 15 from Sex-Q. Score range:1 to 5; total 6 to 30. Higher score indicates better outcome

  17. Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Baseline

    Time frame: Week 2, Week 4, and Week 6

    Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Relationship domain was sum of scores for Questions 7, 8 and 9 from the Sex-Q. Score range: 1 to 5; total 3 to 15. Higher score indicates better outcome.

  18. Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Week 2

    Time frame: Week 4 and Week 6

    Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Relationship domain was sum of scores for Questions 7, 8 and 9 from the Sex-Q. Score range: 1 to 5; total 3 to 15. Higher score indicates better outcome.

  19. Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 on Occasions With Sexual Stimulation- Change From Baseline

    Time frame: Week 2, Week 4 and Week 6

    Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to Question 1 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 1 [Were you able to achieve at least some erection (some enlargement of the penis)?] = Yes) / (number of occasions where Question 1 was answered Yes or No)

  20. Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 Based on Occasions With Sexual Stimulation- Change From Week 2

    Time frame: Week 4 and Week 6

    Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to Question 1 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 1 [Were you able to achieve at least some erection (some enlargement of the penis)?] = Yes) / (number of occasions where Question 1 was answered Yes or No)

  21. Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Baseline

    Time frame: Week 2, Week 4 and Week 6

    Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 2 ["Were you able to insert your penis into your partner's vagina?"] = "Yes") / (number of occasions where SEP Question 2 was answered "Yes" or "No").

  22. Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Week 2

    Time frame: Week 4 and Week 6

    Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 2 ["Were you able to insert your penis into your partner's vagina?"] = "Yes") / (number of occasions where SEP Question 2 was answered "Yes" or "No").

  23. Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 on Occasions With Sexual Stimulation- Change From Baseline

    Time frame: Week 2, Week 4 and Week 6

    Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 3 [Did your erection last long enough for you to have successful intercourse?] = Yes) / (number of occasions where SEP Question 3 was answered Yes or No)

  24. Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 Based on Occasions With Sexual Stimulation- Change From Week 2

    Time frame: Week 4 and Week 6

    Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 3 [Did your erection last long enough for you to have successful intercourse?] = Yes) / (number of occasions where SEP Question 3 was answered Yes or No)

  25. Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Baseline

    Time frame: Week 2, Week 4 and Week 6

    Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Question 4 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 4 ["Were you satisfied with the hardness of your erection?"] = "Yes") / (number of occasions where SEP Question 4 was answered "Yes" or "No").

  26. Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Week 2

    Time frame: Week 4 and Week 6

    Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Question 4 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 4 ["Were you satisfied with the hardness of your erection?"] = "Yes") / (number of occasions where SEP Question 4 was answered "Yes" or "No").

  27. Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Baseline

    Time frame: Week 2, Week 4 and Week 6

    Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Question 5 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 5 ["Were you satisfied with this sexual encounter?"] = "Yes") / (number of occasions where SEP Question 5 was answered "Yes" or "No")

  28. Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Week 2

    Time frame: Week 4 and Week 6

    Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Question 5 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 5 ["Were you satisfied with this sexual encounter?"] = "Yes") / (number of occasions where SEP Question 5 was answered "Yes" or "No")

  29. Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Baseline

    Time frame: Week 2, Week 4, and Week 6

    Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Q3 based on attempts with sexual stimulation (SS): 100* (number of attempts with SS where SEP Q3 [Did your erection last long enough for you to have successful intercourse?] = Yes)/(number of attempts with SS where SEP Q3 was answered Yes or No)

  30. Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Week 2

    Time frame: Week 4 and Week 6

    Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Q3 based on attempts with sexual stimulation (SS): 100* (number of attempts with SS where SEP Q3 [Did your erection last long enough for you to have successful intercourse?] = Yes)/(number of attempts with SS where SEP Q3 was answered Yes or No)

  31. Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Baseline

    Time frame: Week 2, Week 4 and Week 6

    Mean change: mean change at each visit minus mean at baseline. Percent of Grade 1 (1=increase in size, but not hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 1)/(number of occasions where Erection Hardness Scale was answered)

  32. Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Week 2

    Time frame: Week 4 and Week 6

    Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 1 (1=increase in size, but not hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 1)/(number of occasions where Erection Hardness Scale was answered)

  33. Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline

    Time frame: Week 2, Week 4 and Week 6

    Mean change: mean change at each visit minus mean at baseline. Percent of Grade 2 (2= hard, but not hard enough for penetration) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 2)/(number of occasions where Erection Hardness Scale was answered)

  34. Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2

    Time frame: Week 4 and Week 6

    Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 2 (2= hard, but not hard enough for penetration) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 2)/(number of occasions where Erection Hardness Scale was answered)

  35. Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline

    Time frame: Week 2, Week 4 and Week 6

    Mean change: mean change at each visit minus mean at baseline. Percent of Grade 3 (3= hard enough for penetration [but not completely hard]) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3)/(number of occasions where Erection Hardness Scale was answered)

  36. Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2

    Time frame: Week 4 and Week 6

    Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 3 (3= hard enough for penetration [but not completely hard]) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3)/(number of occasions where Erection Hardness Scale was answered)

  37. Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline

    Time frame: Week 2, Week 4 and Week 6

    Mean change: mean change at each visit minus mean at baseline. Percent of Grade 4 (4= completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 4)/(number of occasions where Erection Hardness Scale was answered)

  38. Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2

    Time frame: Week 4 and Week 6

    Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 4 (4= completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 4)/(number of occasions where Erection Hardness Scale was answered)

  39. Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline

    Time frame: Week 2, Week 4 and Week 6

    Mean change: mean change at each visit minus mean at baseline. Percent of Grade 3 (hard enough for penetration [but not completely hard]) or 4 (completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3 or 4)/ (number of occasions where Erection Hardness Scale was answered)

  40. Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2

    Time frame: Week 4 and Week 6

    Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 3 (hard enough for penetration [but not completely hard]) or 4 (completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3 or 4)/ (number of occasions where Erection Hardness Scale was answered)

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A Multicenter, Open Label, High Dose (100mg) Rapid Titration Study, To Evaluate The Efficacy And Satisfaction Of Patrex® (Sildenafil Citrate) In Men With Erectile Dysfunction In Mexico.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 3, 2007
Registry last updated
Feb 18, 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.

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