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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

NCT05196308 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2024-12-04

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • François GIULIANO, MD, PhD · Neuro-Urology-Andrology, Raymond Poincaré Hospital, APHP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-18
Primary Completion
2024-07-23
Completion
2024-11-15

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05196308 on ClinicalTrials.gov