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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
16
330 mcg alprostadil in 2.5% vehicle
330 mcg alprostadil in 0.5% vehicle
100 mg cream vehicle 0.5%.
Warner Chilcott Investigational Study Site
Purchase, New York, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: Visit 3 / Up to 14 Days
Quality of erection
Subject description of quality of erection using non-validated questionnaire. Treatment visits will be separated by at least 2 days.
Time frame: 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.
Time frame: 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.
Time frame: Visit 3 / Up to 14 days
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