- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00468650
A Multicenter, Open Label, To Evaluate The Efficacy And Satisfaction Of Patrex® In Men With Erectile Dysfunction.
January 28, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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.
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
117
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aguascalientes, Mexico, 20000
- Pfizer Investigational Site
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Durango, Mexico, 34300
- Pfizer Investigational Site
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Naucalpan Edo. De Mexico, Mexico
- Pfizer Investigational Site
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D.f.
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Mexico, D.f., Mexico, 11520
- Pfizer Investigational Site
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Mexico, D.f., Mexico, 11850
- Pfizer Investigational Site
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DF
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Mexico, DF, Mexico, 11850
- Pfizer Investigational Site
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Distrito Federal
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Mexico, Distrito Federal, Mexico, 11850
- Pfizer Investigational Site
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Edo. De México
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Naucalpan, Edo. De México, Mexico, 53100
- Pfizer Investigational Site
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Jalisco
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Zapopan, Jalisco, Mexico, 45040
- Pfizer Investigational Site
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Zapopan, Jalisco, Mexico, 45200
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Open label
Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive Patrex® 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 Patrex® 100 mg PRN for the following four weeks.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Week 6 LOCF
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Week 2, Week 4 and Week 6
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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.
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Week 4 and Week 6
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International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Baseline
Time Frame: Week 2, Week 4 and Week 6
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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.
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Week 2, Week 4 and Week 6
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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.
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Week 4 and Week 6
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International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Baseline
Time Frame: Week 2, Week 4 and Week 6
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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.
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Week 2, Week 4 and Week 6
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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.
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Week 4 and Week 6
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International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Baseline
Time Frame: Week 2, Week 4, and Week 6
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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.
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Week 2, Week 4, and Week 6
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International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Week 2
Time Frame: Week 4 and Week 6
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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.
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Week 4 and Week 6
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International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Baseline
Time Frame: Week 2, Week 4 and Week 6
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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.
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Week 2, Week 4 and Week 6
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International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Week 2
Time Frame: Week 4 and Week 6
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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.
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Week 4 and Week 6
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Quality of Erection Questionnaire (QEQ): Total Score - Change From Baseline
Time Frame: Week 2, Week 4, and Week 6
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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.
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Week 2, Week 4, and Week 6
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Quality of Erection Questionnaire (QEQ): Total Score- Change From Week 2
Time Frame: Week 4 and Week 6
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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.
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Week 4 and Week 6
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Sexual Experience Questionnaire (Sex-Q): Erection Domain - Change From Baseline
Time Frame: Week 2, Week 4 and Week 6
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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.
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Week 2, Week 4 and Week 6
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Sexual Experience Questionnaire (Sex-Q): Erection Domain- Change From Week 2
Time Frame: Week 4 and Week 6
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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.
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Week 4 and Week 6
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Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Baseline
Time Frame: Week 2, Week 4, and Week 6
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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
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Week 2, Week 4, and Week 6
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Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Week 2
Time Frame: Week 4 and Week 6
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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
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Week 4 and Week 6
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Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Baseline
Time Frame: Week 2, Week 4, and Week 6
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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.
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Week 2, Week 4, and Week 6
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Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Week 2
Time Frame: Week 4 and Week 6
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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.
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Week 4 and Week 6
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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
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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)
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Week 2, Week 4 and Week 6
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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
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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)
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Week 4 and Week 6
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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
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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").
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Week 2, Week 4 and Week 6
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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
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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").
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Week 4 and Week 6
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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
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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)
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Week 2, Week 4 and Week 6
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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
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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)
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Week 4 and Week 6
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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
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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").
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Week 2, Week 4 and Week 6
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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
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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").
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Week 4 and Week 6
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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
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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")
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Week 2, Week 4 and Week 6
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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
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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")
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Week 4 and Week 6
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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
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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)
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Week 2, Week 4, and Week 6
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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
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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)
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Week 4 and Week 6
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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
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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)
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Week 2, Week 4 and Week 6
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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
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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)
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Week 4 and Week 6
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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
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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)
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Week 2, Week 4 and Week 6
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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
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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)
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Week 4 and Week 6
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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
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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)
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Week 2, Week 4 and Week 6
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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
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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)
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Week 4 and Week 6
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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
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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)
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Week 2, Week 4 and Week 6
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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
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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)
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Week 4 and Week 6
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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
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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)
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Week 2, Week 4 and Week 6
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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
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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)
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Week 4 and Week 6
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
February 1, 2008
Study Completion (Actual)
February 1, 2008
Study Registration Dates
First Submitted
May 1, 2007
First Submitted That Met QC Criteria
May 1, 2007
First Posted (Estimate)
May 3, 2007
Study Record Updates
Last Update Posted (Actual)
February 18, 2021
Last Update Submitted That Met QC Criteria
January 28, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A1481251
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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