Trial Information

Summary: 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 Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double Blind
  • Control: Active
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

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: 06/17/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Huntsville, AL 35801
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: June 30, 2008 at 3:06:18 PM


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