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

PHASE2CompletedINTERVENTIONAL
Enrollment

226

Participants

Timeline

Start Date

March 18, 2022

Primary Completion Date

July 23, 2024

Study Completion Date

November 15, 2024

Conditions
Erectile Dysfunction
Interventions
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."

Trial Locations (1)

92380

Neuro-Urology-Andrology, Physical Medicine and Rehabilitation Department, Raymond Poincaré Hospital, APHP, Garches

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER