Efficacy & Safety of Single Dose Alprostadil Cream (2 Concentrations Enhancer) to Vehicle in Men w/Erectile Dysfunction

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety & efficacy of a single dose of alprostadil cream with 2 concentrations of WC3036 compared to vehicle alone in men with erectile dysfunction.

Official Title
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A Study to Assess the Relative Efficacy and Safety of a Single Dose of Alprostadil Cream Combined With 2 Concentrations of WC3036 Compared to Vehicle in Subjects With Erectile Dysfunction

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Drug: WC3036-11F/Alprostadil in Vehicle 2.5%
* Drug: WC3036-12F/Alprostadil in Vehicle 0.5%
* Drug: WC3036-13P/Vehicle Only 0.5%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subject aged 40 or older of any race History of ED (erectile dysfunction) of at least 3 months duration defined as inability to attain & maintain an erection of the penis sufficient to permit satisfactory sexual intercourse Completed and signed informed consent prior to any study related procedures Exclusion Criteria: History/presence any significant disease that Investigator feels will interfere with course of the study Anatomic deformity of penis History/presence alcoholism or drug abuse/dependence within past 2 years (discretion of Investigator) Participation in investigational study drug trial within 30 days prior to randomization

Ages Eligible for Study
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Minimum Age: 40 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: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: WC3036-11F/Alprostadil in Vehicle 2.5%<br>Treatment A | Drug: WC3036-11F/Alprostadil in Vehicle 2.5%<br>* 330 mcg alprostadil in 2.5% vehicle<br>* Other names: 11F;|
| Experimental: WC3036-12F/Alprostadil in Vehicle 0.5%<br>Treatment B | Drug: WC3036-12F/Alprostadil in Vehicle 0.5%<br>* 330 mcg alprostadil in 0.5% vehicle<br>* Other names: 12F;|
| Placebo Comparator: WC3036-13P/Vehicle Only 0.5%<br>Treatment C | Drug: WC3036-13P/Vehicle Only 0.5%<br>* 100 mg cream vehicle 0.5%.<br>* Other names: Vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penile rigidity | ≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days. | Visit 1 / Up to 5 days ± 3 days | 
| Penile rigidity | ≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days. | Visit 2 / Up to 9 days ± 3 days | 
| Penile rigidity | ≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days. | Visit 3 / Up to 14 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of erection | Subject description of quality of erection using non-validated questionnaire. Treatment visits will be separated by at least 2 days. | Visit 1 / Up to 5 days ± 3 days | 
| Quality of erection | Subject description of quality of erection using non-validated questionnaire. Treatment visits will be separated by at least 2 days. | Visit 2 / Up to 9 days ± 3 days | 
| Quality of erection | Subject description of quality of erection using non-validated questionnaire. Treatment visits will be separated by at least 2 days. | Visit 3 / Up to 14 days |