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

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT05196308
Phase
PHASE2
Status
Completed

Conditions

  • Erectile Dysfunction

Eligibility Criteria

Sex
MALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Investigational product administration Xeomin® (MERZ PHARMACEUTICALS GMBH) — DRUG
    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.
  • Placebo administration — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 18, 2022
Status verified
Nov 2024
Primary completion
Jul 23, 2024
Completion
Nov 15, 2024

Study Design

Enrollment
226 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Xeomin® receivers
    Patients will receive Xeomin®.
  • Placebo Comparator: Placebo receivers
    Patients will receive placebo injection instead of Xeomin®.

Primary Outcome Measure

Change in the erectile function [ Time Frame: at baseline and month 3 ]

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