Trial · NCT06768177
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in erectile function | 24 WEEKS | Change in erectile function defined as the % of patients in each group achieving MCID in the IIEF-EF domain from baseline to 24 weeks (i.e. 12 weeks after the end of full treatment): * MCID (Minimal clinically important differences) is based on the severity of ED at baseline as: * Improvement of 5 or points more in IIEF score for patients with moderate ED (8-11) at baseline * Improvement of 2 or more points in IIEF score for patients with severe ED (5-7) at baseline |
| Secondary | EHS | 24 WEEKS | Time frame: change from baseline and at 8 weeks, 16 weeks, and 24 weeks Any value above 0 (0 = The penis does not enlarge) |
| Secondary | The percentage of patients in each group who achieve MCID in the IIEF-EF domain from baseline after treatment with PRP | 24 WEEKS | MCID (Minimal Clinically Important Differences) is defined on the severity of ED at baseline as: * An improvement of 5 or more points in the IIEF score for patients with moderate ED (8-11) at baseline * An improvement of 2 or more points in the IIEF score for patients with severe ED (5-7) at baseline |
| Secondary | The percentage of patients in each group who achieve MCID in the IIEF-EF domain from baseline after treatment with prostaglandin | 24 WEEKS | MCID (Minimal Clinically Important Differences) is defined on the severity of ED at baseline as: * An improvement of 5 or more points in the IIEF score for patients with moderate ED (8-11) at baseline * An improvement of 2 or more points |
| Secondary | The difference in the IIEF score from baseline to the end of treatment between the PRP group and the prostaglandin-treated group. | 24 WEEKS | The difference in the IIEF score from baseline to the end of treatment between the PRP group and the prostaglandin-treated group. |
| Secondary | SEP | 24 WEEKS | Change in SEP: * Response to questions 2 and 3 (SEP-Q2: Were you able to insert your penis into your partner's vagina? / SEP-Q3: Did your erection last long enough to allow you to have successful intercourse?) * Change from baseline (= "YES" response) o At T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment) |
| Secondary | GAQ | 24 WEEKS | Response to GAQ questions 1 and 2 (GAQ-Q1: Has the treatment you are taking improved your erectile function? / GAQ-Q2: If yes, has the treatment improved your ability to engage in sexual activity?) Change at T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment) o Change from baseline (= "YES" response) |
| Secondary | QEQ | 24 WEEKS | At T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment) o Improvement of 2 or more in the score |
| Secondary | Change in EDITS between PRP vs. prostaglandins | At T1 (2 weeks after the end of the first cycle) and T2 (2 weeks after the end of the second cycle) | At T1 (2 weeks after the end of the first cycle) and T2 (2 weeks after the end of the second cycle) |
| Secondary | Change in TSS between PRP vs. prostaglandins | 3 months after the end of the complete treatment | Change in TSS between PRP vs. prostaglandins at T3 (3 months after the end of the complete treatment) |
| Secondary | Change in SHIM | 24 WEEKS | Change in SHIM * At T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment) * Improvement of 2 or more points in the score |
| Secondary | ECDPD - Peak Systolic Velocity (PSV) | 24 WEEKS | ECDPD - Peak Systolic Velocity (PSV): * To assess penile hemodynamics from baseline to T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment) * Recording of arterial penile velocity (cm/s) o Improvement in cm/s (any \> 30 cm/s) |
| Secondary | ECDPD - Resistance Index (RI) | 24 WEEKS | ECDPD - Resistance Index (RI): * To assess penile hemodynamics from baseline to T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment) * Penile vascular resistance index (ratio) o Improvement (any increase up to the normal value - 0.9) |
| Secondary | ECDPD - End-Diastolic Velocity (EDV) | 24 WEEKS | ECDPD - End-Diastolic Velocity (EDV): * To assess penile hemodynamics from baseline to T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment) * Recording of residual flow in a vessel at the end of the diastolic phase (cm/s) * Improvement in cm/s (any decrease in cm/s) |
| Secondary | Adverse events | 24 WEEKS | Adverse events: Number of participants who experienced treatment-related adverse events. Defined as: skin reaction (e.g., swelling, erythema, and warmth), discomfort at the injection site, penile pain, change in penile appearance, new sexual problems, and any systemic reaction observed by investigators or concerns expressed by patients o At T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment) |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT06768177/registered