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Study of udenafil daily in subjects with mild or no erectile dysfunction to evaluate effects on semen characteristics.
Safety Study in male subjects with no or mild ED (erectile dysfunction)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| Udenafil | Active Comparator | Udenafil daily tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Daily, oral tablet |
| |
| Udenafil |
| Measure | Description | Time Frame |
|---|---|---|
| Sperm Concentration Reduction greater than or equal to 50% at Week 26 | Percentage of Subjects with greater than or equal to 50% decrease from baseline in sperm concentration at 26 weeks | 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herman Ellman, MD | Warner Chilcott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warner Chilcott Investigational Site | Huntsville | Alabama | 35801 | United States | ||
| Warner Chilcott Investigational Site |
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| Drug |
Daily tablet |
|
| Anaheim |
| California |
| 92801 |
| United States |
| Warner Chilcott Investigational Site | San Diego | California | 92103 | United States |
| Warner Chilcott Investigational Site | San Diego | California | 92120 | United States |
| Warner Chilcott Investigational Site | Tarzana | California | 91356 | United States |
| Warner Chilcott Investigational Site | Middlebury | Connecticut | 06762 | United States |
| Warner Chilcott Investigational Site | Aventura | Florida | 33180 | United States |
| Warner Chilcott Investigational Site | Clearwater | Florida | 33759 | United States |
| Warner Chilcott Investigational Site | Doral | Florida | 33166 | United States |
| Warner Chilcott Investigational Site | Ocala | Florida | 34474 | United States |
| Warner Chilcott Investigational Site | Pinellas Park | Florida | 33782 | United States |
| Warner Chilcott Investigational Site | Atlanta | Georgia | 30342 | United States |
| Warner Chilcott Investigational Site | Shreveport | Louisiana | 71115 | United States |
| Warner Chilcott Investigational Site | Plainsboro | New Jersey | 08536 | United States |
| Warner Chilcott Investigational Site | Garden City | New York | 11530 | United States |
| Warner Chilcott Investigational Site | Great Neck | New York | 11021 | United States |
| Warner Chilcott Investigational Site | Purchase | New York | 10577 | United States |
| Warner Chilcott Investigational Site | Williamsville | New York | 14221 | United States |
| Warner Chilcott Investigational Site | Cincinnati | Ohio | 45212 | United States |
| Warner Chilcott Investigational Site | San Antonio | Texas | 78229 | United States |
| Warner Chilcott Investigational Site | Webster | Texas | 77598 | United States |
| Warner Chilcott Investigational Site | Norfolk | Virginia | 23507 | United States |
| Warner Chilcott Investigational Site | Spokane | Washington | 99204 | United States |
| 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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| ID | Term |
|---|---|
| C419664 | udenafil |
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