Treatment of Erectile Dysfunction - Long Term Safety and Efficacy

Warner Chilcott1,027 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,027

Conditions

Erectile Dysfunction

Interventions

Udenafil 50 mgDRUG

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.

Udenafil 100 mgDRUG

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.

Udenafil 150 mgDRUG

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.

Eligibility

Sex: MALEMin age: 19 Years

Medical Language ↔ Plain English

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 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

Locations (72)

Outcomes

Primary Outcomes

International Index of Erectile Function (IIEF) score

Time frame: Assessment will be made after each use of the study drug over a 36 week use period.

Secondary Outcomes

Changes in the satisfaction of intercourse, orgasmic function, sexual desire and overall satisfaction

Time frame: Assessment will be made after each use of the study drug over a 36 week use period.

Data from ClinicalTrials.gov

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