Trial information
A Study of MC4 Agonist in Patients With Male Erectile Dysfunction
Status: Completed
Protocol number: NU18390
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind study of the safety and efficacy of MC4 Agonist, compared to that of sildenafil, in patients with male erectile dysfunction
Brief summary: This study will evaluate the efficacy, safety, and tolerability of MC4 Agonist, compared to placebo and sildenafil, in patients with male erectile dysfunction (MED). The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
Target sample size is
48.
Study phase: II
Study type: Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety/Efficacy study
Condition: Erectile Dysfunction
Intervention type: Drug
Intervention name: MC4 Agonist
Primary outcome: 1. Safety: Vital signs, ECGs, clinical laboratory tests, observed and self-reported adverse events
Efficacy: Cumulative duration of rigidity greater than or equal to 60% at the base of the penis from 15 minutes postdose through 140 minutes postdose
Key secondary outcomes: 1. Efficacy: Cumulative duration of rigidity greater than or equal to 80% at the base of the penis, cumulative duration of rigidity greater than or equal to 60% and 80% at the tip of the penis
Inclusion criteria:
- male patients 21-65 years of age;
- MED of a continual duration of >=6 months;
- mild to moderate MED documented at screening.
Exclusion criteria:
- participation in an investigational drug or medical device study within the last 30 days;
- if capable of reproduction, unwillingness to use an effective form of contraception;
- conditions that predispose to priapism.
Gender: Males
Age limits: Min: 21 Years Max: 65 Years
Accepts healthy volunteers: No
Trial registration date: 08/17/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
United States
- Huntsville, AL
- Tarzana, CA
- Waterbury, CT
- Piscataway, NJ
