NCT01037218

Treatment of Erectile Dysfunction II

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: 601 (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).

Detailed description

Multi-center, randomized, double-blind, placebo-controlled, parallel-group design, Phase 3 pivotal study to investigate the efficacay and safety of 50 mg, 100 mg and 150 mg udenafil tablets compared with placebo in men with ED. This study consisted of a 4-week, treatment free run-in period followed by a treatment period of 12 weeks, with an on-demand dosing regimen.

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: 2010-04-01
• Completion: 2010-04-01
• First posted: 2009-12-22
• Last updated: 2015-06-19
• Results posted: 2011-12-22

Locations

40 sites across 1 country: United States