Efficacy of Intracavernosal as add-on Therapy to Sildenafil 100 mg on Demand Compared to Sildenafil 100 mg on Demand for the Treatment of Erectile Dysfunction (ED) Not Sufficiently Responsive to Standard Therapy With Phosphodiesterase Type 5 Inhibit

• Status: Not yet recruiting
• Trial end date: 2024-01-01

Summary

The primary objective of this study is to investigate the efficacy of intracavernosal (Xeomin®) (100U) as add-on therapy to sildenafil 100 mg on demand in men with ED and insufficient response to standard therapy with 100 mg sildenafil on demand during the 4-week open-label run-in phase.

The secondary objectives are to further describe the efficacy and safety of (Xeomin®) 100U IC as add-on therapy to sildenafil 100 mg on demand:

1. to further assess efficacy using.

• i) a log diary five-item questionnaire completed after each sexual attempt (Sexual Encounter Profile);

• ii) a self-reporting measure that scores erection hardness on a 4 point scale completed after each sexual attempt;

• iii) The Global Assessment Question.

2. to assess effect persistence at month 6 and month 9.

3. to assess safety of (Xeomin®) 100U IC in combination with sildenafil 100 mg on demand.

• Phase: Phase 2

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: incobotulinumtoxinA