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Re-assessment of study
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WC3036-11F/Alprostadil in Vehicle 2.5% | Active Comparator | Treatment A |
|
| WC3036-12F/Alprostadil in Vehicle 0.5% | Experimental | Treatment B |
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| WC3036-13P/Vehicle Only 0.5% | Placebo Comparator | Treatment C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WC3036-11F/Alprostadil in Vehicle 2.5% | Drug | 330 mcg alprostadil in 2.5% vehicle |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vilma Sniukiene, MD | Warner Chilcott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warner Chilcott Investigational Study Site | Purchase | New York | 10755 | United States |
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| WC3036-12F/Alprostadil in Vehicle 0.5% | Drug | 330 mcg alprostadil in 0.5% vehicle |
|
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| WC3036-13P/Vehicle Only 0.5% | Drug | 100 mg cream vehicle 0.5%. |
|
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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 |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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