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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).
Patients completing the double-blind phase will be entered into Study 01409 at the intermediate dose. Up and down dose adjustments will be allowed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Udenafil 50 mg | Experimental | 50 mg Udenafil |
|
| Udenafil 100 mg | Experimental | 100 mg Udenafil |
|
| Udenafil 150 mg | Experimental | 150 mg Udenafil |
|
| Placebo | Placebo Comparator | Placebo Tablets matching Udenafil tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Udenafil 50 mg | Drug | 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. |
| 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. |
| 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. |
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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 | Birmingham | Alabama | 35209 | United States | ||
| Warner Chilcott Investigational Site |
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|
| Udenafil 100 mg | Drug | 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. |
|
|
| Udenafil 150 mg | Drug | 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. |
|
|
| Placebo Matching 50 mg Udenafil | Drug | 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. |
|
|
| Placebo Matching 100 mg Udenafil | Drug | 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. |
|
|
| Placebo Matching 150 mg Udenafil | Drug | 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. |
|
|
| Homewood |
| Alabama |
| 35209 |
| United States |
| Warner Chilcott Investigational Site | Huntsville | Alabama | 35801 | United States |
| Warner Chilcott Investigational Site | Mesa | Arizona | 85213 | United States |
| Warner Chilcott Investigational Site | Phoenix | Arizona | 85023 | United States |
| Warner Chilcott Investigational Site | Tempe | Arizona | 85282 | United States |
| Warner Chilcott Investigational Site | Tucson | Arizona | 85741 | United States |
| Warner Chilcott Investigational Site | Chino | California | 91710 | United States |
| Warner Chilcott Investigational Site | Laguna Hills | California | 92653 | United States |
| Warner Chilcott Investigational Site | Newport Beach | California | 92660 | United States |
| Warner Chilcott Investigational Site | San Diego | California | 92103 | United States |
| Warner Chilcott Investigational Site | Tarzana | California | 91356 | United States |
| Warner Chilcott Investigative Site | Torrance | California | 90505 | United States |
| Warner Chilcott Investigational Site | Denver | Colorado | 80211 | United States |
| Warner Chilcott Investigational Site | Englewood | Colorado | 80113 | United States |
| Warner Chilcott Investigational Site | Middlebury | Connecticut | 06762 | United States |
| Warner Chilcott Investigational Site | Milford | Connecticut | 06460 | United States |
| Warner Chilcott Investigative Site | New Britain | Connecticut | 06052 | United States |
| Warner Chilcott Investigational Site | Waterbury | Connecticut | 06708 | United States |
| Warner Chilcott Investigational Site | Aventura | Florida | 33180 | United States |
| Warner Chilcott Investigational Site | Clearwater | Florida | 33761 | United States |
| Warner Chilcott Investigational Site | Daytona Beach | Florida | 32114 | United States |
| Warner Chilcott Investigational Site | DeLand | Florida | 32720 | United States |
| Warner Chilcott Investigational Site | Miami | Florida | 33143 | United States |
| Warner Chilcott Investigational Site | Ocala | Florida | 34471 | United States |
| Warner Chilcott Investigational Site | Ocala | Florida | 34474 | United States |
| Warner Chilcott Investigational Site | Tampa | Florida | 33607 | United States |
| Warner Chilcott Investigational Site | Columbus | Georgia | 31904 | United States |
| Warner Chilcott Investigational Site | Dawsonville | Georgia | 30534 | United States |
| Warner Chilcott Investigational Site | Sandy Springs | Georgia | 30328 | United States |
| Warner Chilcott Investigational Site | Melrose Park | Illinois | 60160 | United States |
| Warner Chilcott Investigational Site | Fort Wayne | Indiana | 46825 | United States |
| Warner Chilcott Investigational Site | Greenwood | Indiana | 46143 | United States |
| Warner Chilcott Investigational Site | Jeffersonville | Indiana | 47130 | United States |
| Warner Chilcott Investigational Site | West Des Moines | Iowa | 50266 | United States |
| Warner Chilcott Investigational Site | Elkridge | Maryland | 21075 | United States |
| Warner Chilcott Investigational Site | Omaha | Nebraska | 68114 | United States |
| Warner Chilcott Investigational Site | Las Vegas | Nevada | 89106 | United States |
| Warner Chilcott Investigational Site | Lawrenceville | New Jersey | 08648 | United States |
| Warner Chilcott Investigational Site | Bay Shore | New York | 11706 | United States |
| Warner Chilcott Investigational Site | Garden City | New York | 11530 | United States |
| Warner Chilcott Investigational Site | Kingston | New York | 12401 | United States |
| Warner Chilcott Investigational Site | New York | New York | 10016 | United States |
| Warner Chilcott Investigational Site | Poughkeepsie | New York | 12601 | United States |
| Warner Chilcott Investigational Site | Rochester | New York | 14609 | United States |
| Warner Chilcott Investigational Site | Williamsville | New York | 14221 | United States |
| Warner Chilcott Investigational Site | Cary | North Carolina | 27518 | United States |
| Warner Chilcott Investigational Site | Concord | North Carolina | 28025 | United States |
| Warner Chilcott Investigational Site | Harrisburg | North Carolina | 28075 | United States |
| Warner Chilcott Investigational Site | Raleigh | North Carolina | 27609 | United States |
| Warner Chilcott Investigational Site | Raleigh | North Carolina | 27612 | United States |
| Warner Chilcott Investigational Site | Salisbury | North Carolina | 28144 | United States |
| Warner Chilcott Investigational Site | Wilmington | North Carolina | 28401 | United States |
| Warner Chilcott Investigative Site | Wilmington | North Carolina | 28401 | United States |
| Warner Chilcott Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Warner Chilcott Investigational Site | Cincinnati | Ohio | 45212 | United States |
| Warner Chilcott Investigational Site | Cleveland | Ohio | 44122 | United States |
| Warner Chilcott Investigational Site | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Warner Chilcott Investigational Site | Jenkintown | Pennsylvania | 19046 | United States |
| Warner Chilcott Investigational Site | Lancaster | Pennsylvania | 17604 | United States |
| Warner Chilcott Investigational Site | Greer | South Carolina | 29650 | United States |
| Warner Chilcott Investigational Site | Mt. Pleasant | South Carolina | 29464 | United States |
| Warner Chilcott Investigational Site | Myrtle Beach | South Carolina | 29572 | United States |
| Warner Chilcott Investigational Site | Arlington | Texas | 76017 | United States |
| Warner Chilcott Investigational Site | San Antonio | Texas | 78229 | United States |
| Warner Chilcott Investigational Site | Sugar Land | Texas | 77479 | United States |
| Warner Chilcott Investigational Site | Salt Lake City | Utah | 84107 | United States |
| Warner Chilcott Investigational Site | Norfolk | Virginia | 23502 | United States |
| Warner Chilcott Investigational Site | Richmond | Virginia | 23294 | United States |
| Warner Chilcott Investigational Site | Mountlake Terrace | Washington | 98043 | United States |
| Warner Chilcott Investigational Site | Spokane | Washington | 99204 | United States |
| Warner Chilcott Investigational Site | Spokane | Washington | 99208 | 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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