Trial information
A Study of Intranasal MC4 Agonist in Patients With Male Erectile Dysfunction.
Status: Terminated
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 type: Interventional; Treatment; Randomized; Double Blind; Active; Crossover; Safety/Efficacy study
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:
- Part A: healthy males, 40-65 years of age;
- Part B: healthy males, 21-65 years of age;
- male erectile dysfunction of continual duration of >=6 months;
- PDE5 responder;
- mild to moderate erectile dysfunction.
Exclusion criteria:
- active nasal congestion, allergic rhinitis and anatomical abnormalities of the nasal cavity;
- tendency to epistaxis;
- current treatment with antihypertensive medication;
- clinically significant cardiovascular disease;
- orthostatic hypotension.
Gender: Males
Age limits: Min: 21 Years Max: 65 Years
Accepts healthy volunteers: No
Trial registration date: 10/17/2006
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
United States
