Treatment of Erectile Dysfunction - Long Term Safety and Efficacy

Phase 3

Completed

• Conditions: Erectile Dysfunction
• Interventions: Drug: Udenafil 150 mg; Drug: Udenafil 50 mg; Drug: Udenafil 100 mg; Drug: Placebo Matching 100 mg Udenafil; Drug: Placebo Matching 50 mg Udenafil; Drug: Placebo Matching 150 mg Udenafil

• Registration Number: NCT01065012
• Lead Sponsor: Warner Chilcott

Brief 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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-05
• Study First Submitted QC: 2010-02-05
• Study First Posted: 2010-02-09
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Disposition First Submitted: 2012-04-11
• Disposition First Submitted QC: 2012-04-11
• Disposition First Posted: 2012-04-16
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1027

Inclusion Criteria

• Subject has completed Study PR-01209 or PR-01309
• Continues in a stable monogamous relationship with a consenting female partner who is at least 19 years of age.
• Partner is not pregnant or lactating

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Exclusion Criteria

• Symptomatic coronary artery disease, myocardial infarction or cardiac surgical procedure.
• Cardiac arrhythmias requiring antiarrhythmic treatment
• Symptomatic congestive heart failure
• Taking nitrate medication in any form
• Uncontrolled diabetes (HbA1c ≥ 13%)
• Hypersensitivity to phosphodiesterase type 5 (PDE-5) inhibitors

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Udenafil 50 mg	Placebo Matching 100 mg Udenafil	50 mg Udenafil
Udenafil 150 mg	Udenafil 150 mg	150 mg Udenafil
Udenafil 50 mg	Placebo Matching 150 mg Udenafil	50 mg Udenafil
Placebo	Placebo Matching 150 mg Udenafil	Placebo Tablets matching Udenafil tablets
Udenafil 100 mg	Placebo Matching 150 mg Udenafil	100 mg Udenafil
Udenafil 50 mg	Udenafil 50 mg	50 mg Udenafil
Udenafil 100 mg	Udenafil 100 mg	100 mg Udenafil
Udenafil 100 mg	Placebo Matching 50 mg Udenafil	100 mg Udenafil
Udenafil 150 mg	Placebo Matching 50 mg Udenafil	150 mg Udenafil
Udenafil 150 mg	Placebo Matching 100 mg Udenafil	150 mg Udenafil
Placebo	Placebo Matching 100 mg Udenafil	Placebo Tablets matching Udenafil tablets
Placebo	Placebo Matching 50 mg Udenafil	Placebo Tablets matching Udenafil tablets

Primary Outcome Measures

Name	Time	Method
International Index of Erectile Function (IIEF) score	Assessment will be made after each use of the study drug over a 36 week use period.

Secondary Outcome Measures

Name	Time	Method
Changes in the satisfaction of intercourse, orgasmic function, sexual desire and overall satisfaction	Assessment will be made after each use of the study drug over a 36 week use period.

Trial Locations

Locations (2)

Warner Chilcott Investigational Site; 🇺🇸 Spokane, Washington, United States

Warner Chilcott Investigative Site; 🇺🇸 Wilmington, North Carolina, United States