Treatment of Erectile Dysfunction - Long Term Safety and Efficacy

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

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

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Drug: Udenafil 50 mg
* Drug: Udenafil 100 mg
* Drug: Udenafil 150 mg
* Drug: Placebo Matching 50 mg Udenafil
* Drug: Placebo Matching 100 mg Udenafil
* Drug: Placebo Matching 150 mg Udenafil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Udenafil 50 mg<br>50 mg Udenafil | Drug: Udenafil 50 mg<br>* 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.<br>* Other names: WC3043;Drug: Placebo Matching 100 mg Udenafil<br>* 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.<br>* Other names: Placebo 100 mg;Drug: Placebo Matching 150 mg Udenafil<br>* 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.<br>* Other names: Placebo 150 mg;|
| Experimental: Udenafil 100 mg<br>100 mg Udenafil | Drug: Udenafil 100 mg<br>* 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.<br>* Other names: WC3043;Drug: Placebo Matching 50 mg Udenafil<br>* 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.<br>* Other names: Placebo 50 mg;Drug: Placebo Matching 150 mg Udenafil<br>* 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.<br>* Other names: Placebo 150 mg;|
| Experimental: Udenafil 150 mg<br>150 mg Udenafil | Drug: Udenafil 150 mg<br>* 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.<br>* Other names: WC3043;Drug: Placebo Matching 50 mg Udenafil<br>* 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.<br>* Other names: Placebo 50 mg;Drug: Placebo Matching 100 mg Udenafil<br>* 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.<br>* Other names: Placebo 100 mg;|
| Placebo Comparator: Placebo<br>Placebo Tablets matching Udenafil tablets | Drug: Placebo Matching 50 mg Udenafil<br>* 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.<br>* Other names: Placebo 50 mg;Drug: Placebo Matching 100 mg Udenafil<br>* 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.<br>* Other names: Placebo 100 mg;Drug: Placebo Matching 150 mg Udenafil<br>* 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.<br>* Other names: Placebo 150 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |