Trial · NCT00836693
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12 | Baseline, Week 12 | Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30. |
| Primary | Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses | Baseline, Week 12 | Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2. "Were you able to insert your penis into your partner's vagina?" Data are presented as the mean percentage of yes responses per participant. |
| Primary | Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses | Baseline, 12 weeks | Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3. "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per participant. |
| Secondary | Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night | Baseline, Week 12 | NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The man wears the device for three nights prior to visit 2 (baseline), visit 5 (end of randomised treatment) and visit 6 (end of follow-up). Data are entered for the 2 nights prior to the visit. During the night the man may have multiple erections. The number of erections is recorded. |
| Secondary | Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night | Baseline, Week 12 | NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The duration of erections are measured and recorded. Data presented are the duration of erectile events at baseline and the change from baseline to Week 12. |
| Secondary | Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change | Baseline, Week 12 | NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The percent of volume change of the penis during erections is measured and recorded for each erection. Data presented are mean percentage of volumetric change from baseline to Week 12. |
| Secondary | Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary | Baseline, 12 weeks | The morning erection diary allows the participant to record whether he experienced an erection on waking. The participant is to complete the morning erection diary every morning during the run-in, treatment and follow-up periods. The percentage of mornings the participant reported an erection is analysed. |
| Secondary | The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint | Week 12 | The subject questionnaire consists of 11 questions. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS summary score will be obtained by adding each individual result for all questions, dividing by the number of questions answered (mean satisfaction score), and multiplying by 25, thus obtaining a score that ranges from 0 (extremely low treatment satisfaction) to 100 (extremely high satisfaction). |
| Secondary | Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire | Baseline, Week 12 | SEAR measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). All questions except negatively worded questions 8 and 11 are scored from 1=almost never/never to 5=almost always/always. Questions 8 and 11 were reverse scored, thus a higher score signifies a more favorable response for all 14 items. Overall score is transformed into a 0 (least favorable) to 100 (most favorable) scale. |
| Secondary | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF) | Baseline, Week 12 | Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 2 questions of the IIEF-OF domain range from 0 to 10. |
| Secondary | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD) | Baseline, 12 weeks | Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-SD domain range from 0 to 10. |
| Secondary | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS) | Baseline, Week 12 | Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15. |
| Secondary | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS) | Baseline, 12 weeks | Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10. |
| Secondary | Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of "Yes" Responses | Baseline, 12 weeks | Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 1. "Were you able to achieve at least some erection (some enlargement of the penis)? " Data are presented as the mean percentage of yes responses per participant. |
| Secondary | Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of "Yes" Responses | Baseline, 12 weeks | Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4. "Were you satisfied with the hardness of your erection?" Data are presented as the mean percentage of yes responses per participant. |
| Secondary | Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of "Yes" Responses | Baseline, 12 weeks | Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5. "Were you satisfied overall with this sexual experience?" Data are presented as the mean percentage of yes responses per participant. |
| Secondary | Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint | Week 12 | GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from 1=very much better to 7=very much worse. |
| Secondary | Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint | Week 12 | GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from 1=very much better to 7=very much worse. |
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.
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