NCT01037244

Treatment of Erectile Dysfunction I

Randomized, Placebo-controlled, Double-Blind, Parallel Design, Phase 3 Study to Assess the Safety and Efficacy of Udenafil Tablets in Male Subjects With Erectile Dysfunction

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 618 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Randomized, placebo-controlled, double-blind, parallel design, Phase 3 study to evaluate the safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of PDE-5 versus placebo for the treatment of subjects with erectile dysfunction (ED).

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	Udenafil	Tablets via oral administration before an attempt at sexual intercourse.
DRUG	Placebo	Tablets via oral administration before an attempt at sexual intercourse.

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2009-12-22
• Last updated: 2011-12-22
• Results posted: 2011-12-22

Locations

36 sites across 1 country: United States