NCT01065012

Treatment of Erectile Dysfunction - Long Term Safety and Efficacy

Open-Label Phase 3 Study to Evaluate the Long-Term Safety and Efficacy of Udenafil Tablets in Male Subjects With Erectile Dysfunction

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,027 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Open-Label Phase 3 study to evaluate the long-term safety and efficacy of udenafil, an orally administered selective inhibitor of PDE-5 for the treatment of subjects with erectile dysfunction (ED).

Detailed description

Patients completing the double-blind phase will be entered into Study 01409 at the intermediate dose. Up and down dose adjustments will be allowed.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	Udenafil 50 mg	Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
DRUG	Udenafil 100 mg	Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
DRUG	Udenafil 150 mg	Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
DRUG	Placebo Matching 50 mg Udenafil	Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
DRUG	Placebo Matching 100 mg Udenafil	Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
DRUG	Placebo Matching 150 mg Udenafil	Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2010-02-09
• Last updated: 2015-04-20

Locations

72 sites across 1 country: United States