Trial Information

Summary: A Study of Intranasal MC4 Agonist in Patients With Male Erectile Dysfunction.

Status: Completed

Protocol Number: PP20441

Sponsor: Hoffmann-La Roche Inc

Company Division: Pharmaceutical

Official Scientific Title: A randomized, observer-blinded study to evaluate the pharmacodynamic effects and overall safety of MC4 agonist in patients with male erectile dysfunction

Brief Summary: This study will assess the effect of MC4 agonist on blood pressure in healthy males, and its effect on erectile function in patients with male erectile dysfunction. In Part A of the study, healthy male subjects will receive single doses of MC4 agonist, 8mg intranasally, and placebo, and blood pressure changes will be assessed. In Part B, patients with male erectile dysfunction will receive single doses of MC4 agonist, 8mg intranasally, placebo, and sildenafil 50mg po, and pharmacodynamic effects and safety/tolerability will be assessed. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals. Target sample size is 54.

Study Phase: II

Study Design / Study Details:

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

Study Type:

Condition: Erectile Dysfunction

Intervention Type: Drug

Intervention Name: MC4 Agonist

Primary Outcome: 1. Cumulative duration of rigidity >=60% at base of penis from 20 minutes post-dose through 140 minutes post-dose.

Key Secondary Outcomes: 1. Efficacy: Cumulative duration of rigidity >=80% at base of penis; cumulative duration of rigidity >=60%, and >=80% at tip of penis. Safety: Vital signs, AEs, lab parameters.

Inclusion Criteria:

Exclusion Criteria:

Gender: Males

Age Limits: Min: 21 Years Max: 65 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 10/17/2006

Date Last Updated: 07/15/2008

Link To Trial Results

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: July 21, 2008 at 2:16:26 PM