Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Baseline to Week 6 Last Observation Carried Forward (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. |
Week 6 LOCF |
|
Secondary |
International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score - Change From Baseline at Weeks 2, 4 and 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. |
Week 2, Week 4 and Week 6 |
|
Secondary |
International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Week 2 |
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. |
Week 4 and Week 6 |
|
Secondary |
International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Baseline |
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. |
Week 2, Week 4 and Week 6 |
|
Secondary |
International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Week 2 |
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. |
Week 4 and Week 6 |
|
Secondary |
International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Baseline |
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. |
Week 2, Week 4 and Week 6 |
|
Secondary |
International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Week 2 |
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. |
Week 4 and Week 6 |
|
Secondary |
International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Baseline |
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. |
Week 2, Week 4, and Week 6 |
|
Secondary |
International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Week 2 |
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. |
Week 4 and Week 6 |
|
Secondary |
International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Baseline |
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. |
Week 2, Week 4 and Week 6 |
|
Secondary |
International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Week 2 |
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. |
Week 4 and Week 6 |
|
Secondary |
Quality of Erection Questionnaire (QEQ): Total Score - Change From Baseline |
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. |
Week 2, Week 4, and Week 6 |
|
Secondary |
Quality of Erection Questionnaire (QEQ): Total Score- Change From Week 2 |
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. |
Week 4 and Week 6 |
|
Secondary |
Sexual Experience Questionnaire (Sex-Q): Erection Domain - Change From Baseline |
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. |
Week 2, Week 4 and Week 6 |
|
Secondary |
Sexual Experience Questionnaire (Sex-Q): Erection Domain- Change From Week 2 |
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. |
Week 4 and Week 6 |
|
Secondary |
Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Baseline |
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 |
Week 2, Week 4, and Week 6 |
|
Secondary |
Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Week 2 |
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 |
Week 4 and Week 6 |
|
Secondary |
Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Baseline |
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. |
Week 2, Week 4, and Week 6 |
|
Secondary |
Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Week 2 |
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. |
Week 4 and Week 6 |
|
Secondary |
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 on Occasions With Sexual Stimulation- Change From Baseline |
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) |
Week 2, Week 4 and Week 6 |
|
Secondary |
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 Based on Occasions With Sexual Stimulation- Change From Week 2 |
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) |
Week 4 and Week 6 |
|
Secondary |
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Baseline |
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"). |
Week 2, Week 4 and Week 6 |
|
Secondary |
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Week 2 |
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"). |
Week 4 and Week 6 |
|
Secondary |
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 on Occasions With Sexual Stimulation- Change From Baseline |
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) |
Week 2, Week 4 and Week 6 |
|
Secondary |
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 Based on Occasions With Sexual Stimulation- Change From Week 2 |
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) |
Week 4 and Week 6 |
|
Secondary |
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Baseline |
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"). |
Week 2, Week 4 and Week 6 |
|
Secondary |
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Week 2 |
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"). |
Week 4 and Week 6 |
|
Secondary |
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Baseline |
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") |
Week 2, Week 4 and Week 6 |
|
Secondary |
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Week 2 |
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") |
Week 4 and Week 6 |
|
Secondary |
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Baseline |
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) |
Week 2, Week 4, and Week 6 |
|
Secondary |
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 |
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) |
Week 4 and Week 6 |
|
Secondary |
Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Baseline |
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) |
Week 2, Week 4 and Week 6 |
|
Secondary |
Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Week 2 |
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) |
Week 4 and Week 6 |
|
Secondary |
Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline |
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) |
Week 2, Week 4 and Week 6 |
|
Secondary |
Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 |
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) |
Week 4 and Week 6 |
|
Secondary |
Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline |
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) |
Week 2, Week 4 and Week 6 |
|
Secondary |
Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 |
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) |
Week 4 and Week 6 |
|
Secondary |
Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline |
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) |
Week 2, Week 4 and Week 6 |
|
Secondary |
Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 |
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) |
Week 4 and Week 6 |
|
Secondary |
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 |
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) |
Week 2, Week 4 and Week 6 |
|
Secondary |
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 |
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) |
Week 4 and Week 6 |
|