NCT05196308

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 Inhibitors

Efficacy of Intracavernosal (Xeomin®) 100U 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 Inhibitors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This randomized, double-blind, placebo-controlled study will be conducted in 9 centers, study participants will be adult men with ED and insufficient response to standard therapy with 100 mg sildenafil on demand during the 4-week open label run-in-phase, follow-up in the study will be 10±2 months. This is a standard procedure to use placebo as control in studies assessing the efficacy of pharmacological treatment of ED. Furthermore the placebo group provides a benchmark for an objective analysis of safety and tolerability findings. The open-label run-in phase assures that only subjects who are true non-responders i.e. with insufficient response to standard therapy with 100 mg sildenafil prn during the 4-week open-label run-in phase are randomized and participate in the double-blind treatment phase. Participants distributed between groups at a ratio of 1:1.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	Investigational product administration Xeomin® (MERZ PHARMACEUTICALS GMBH)	Administration of the investigational product. For the double-blind treatment phase, experimental group : Patients will receive Xeomin® (MERZ PHARMACEUTICALS GMBH), 100 U, a paired intracavernosal injection to be performed by the investigator.
DRUG	Placebo administration	For the double-blind treatment phase, control group : Patients will receive placebo of Xeomin® 100 U, a paired intracavernosal injection is to be performed by the investigator.

Timeline

• Start date: 2022-03-18
• Primary completion: 2024-07-23
• Completion: 2024-11-15
• First posted: 2022-01-19
• Last updated: 2024-12-04

Locations

1 site across 1 country: France