Trial · NCT01037218
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward) | Baseline and Week 12 | Erectile Function domain: 0 - 5 scoring scale for each of 6 questions (scale: 0/min/poor - 30/max/good). Over last month: How often were you able to get erection? When you had erections with stimulation, how often were your erections hard enough for penetration? When you attempted intercourse, how often were you able to penetrate your partner? How often were you able to maintain your erection after penetrating your partner? How difficult was it to maintain your erection to completion of intercourse? How do you rate your confidence that you can get \& keep your erection? |
| Primary | Changes in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT | Baseline and Weeks 1-12 | Question 2 SEP: Were you able to insert your penis into your partner's vagina? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period. |
| Primary | Changes in Sexual Encounter Profile (SEP), Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT | Baseline and Weeks 1-12 | Question 3 SEP: Did your erection last long enough for you to have successful completion of intercourse? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period. |
| Secondary | Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Baseline and Week 12 | Satisfaction of Intercourse domain: 0 (poor) - 5/(good) scoring scale for each of 3 questions (0-15/good). Over last month: How many times have you attempted sexual intercourse? When you attempted intercourse, how often was it satisfactory for you? How much have you enjoyed sexual intercourse? |
| Secondary | Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Baseline and Week 12 | Orgasmic Function domain: 0/poor - 5/good scoring scale for each of 2 questions (0-10/good). Over last month, when you had sexual stimulation or intercourse how often did you ejaculate? When you had sexual stimulation or intercourse how often did you have the feeling of orgasm (with or without ejaculation)? |
| Secondary | Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Baseline and Week 12 | Sexual Desire domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how often have you felt sexual desire? How would you rate your level of sexual desire? |
| Secondary | Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Baseline and Week 12 | Overall Satisfaction domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how satisfied have you been with your overall sex life? How satisfied have you been with your sexual relationship with your partner? |
| Secondary | Global Assessment Questionnaire (GAQ), Week 12/Final Visit, mITT Population | Week 12 | While Using the Study Medication, Did You Feel That Your Erections Improved (Yes Responders) |
| Secondary | Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/Final Visit, LOCF, mITT | Baseline and Week 12 | EDITS -sum of responses (mapped to 0/bad-4/good scale, 11 questions standardized to scale of 100): How satisfied are you w/treatment? How likely to continue?, During past 4 wks, has treatment met expectations? How easy to use ? How satisfied w/how quickly it works? How long it lasts? How confident has it made you feel about ability to engage in sex? How satisfied is partner is with treatment effects? How does your partner feel about continuing use? How natural did process of achieving erection feel? Compared to before erection problem, how natural did erection feel in terms of hardness? |
| Secondary | Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population | Baseline and Week 12 | PASE: Chose one: 1) No evidence of tumescence or erection 2) partial tumescence or erection (not likely to be sufficient for penetration) 3) greater tumescence or erection sufficient for vaginal penetration, but not fully rigid 4) full rigidity; scale 1/poor, no evidence of erection - 4/good, full rigidity |
| Secondary | Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT | Baseline and Weeks 1-12 | SEP Question 1: Were you able to achieve at least some erection (some enlargement of the penis)? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period. |
| Secondary | Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT | Baseline and Weeks 1-12 | SEP Question 4: Were you satisfied with the hardness of your erection? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period. |
| Secondary | Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT | Baseline and Weeks 1-12 | SEP Question 5: Were you satisfied with this overall sexual experience? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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