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This is a safety extension study of DR-OXY-301 at pre-selected sites. Subjects who complete the DR-OXY-301 study are eligible to participate. The duration of this extension study will be up to approximately 42 weeks. Subjects will have physical and laboratory exams, including blood draws at each scheduled visit and colposcopic examination of the vagina and cervix. As in DR-OXY-301, subjects will be required to insert a vaginal ring; replacing it every 4 weeks. Subjects will also be required to keep a daily record of the number of times and the total amount of time the ring was outside the body each day and the reason for voluntary removal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxybutinyn Vaginal Ring 4mg | Experimental | inserted daily and replaced every 4 weeks |
|
| Oxybutinyn Vaginal Ring 6mg | Experimental | inserted daily and replaced every 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxybutinyn Vaginal Ring 4mg | Drug |
|
| |
| Oxybutinyn Vaginal Ring 6mg |
| Measure | Description | Time Frame |
|---|---|---|
| Safety, by investigating post void residual volume, physical exams, vital signs, and clinical laboratory values. The outcome of any pregnancy will be followed and reported | Duration of Study |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Duramed Research Protocol Chair | Duramed Research, Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duramed Investigational Site | Phoenix | Arizona | 85015 | United States | ||
| Duramed Investigational Site |
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| Drug |
|
|
| San Diego |
| California |
| 92103 |
| United States |
| Duramed Investigational Site | San Diego | California | 92108 | United States |
| Duramed Investigational Site | Miami | Florida | 33143 | United States |
| Duramed Investigational Site | Tampa | Florida | 33607 | United States |
| Duramed Investigational Site | Augusta | Georgia | 30901 | United States |
| Duramed Investigational Site | Savannah | Georgia | 31406 | United States |
| Duramed Investigational Site | Boise | Idaho | 83712 | United States |
| Duramed Investigational Site | Chicago | Illinois | 60661-3095 | United States |
| Duramed Investigational Site | Wichita | Kansas | 67207 | United States |
| Duramed Investigational Site | Louisville | Kentucky | 40291 | United States |
| Duramed Investigational Site | Watertown | Massachusetts | 02472 | United States |
| Duramed Investigational Site | Las Vegas | Nevada | 89030 | United States |
| Duramed Investigational Site | Las Vegas | Nevada | 89109 | United States |
| Duramed Investigational Site | Las Vegas | Nevada | 89128 | United States |
| Duramed Investigational Site | Moorestown | New Jersey | 08057 | United States |
| Duramed Investigational Site | Albuquerque | New Mexico | 87102 | United States |
| Duramed Investigational Site | Port Jefferson | New York | 11777 | United States |
| Duramed Investigational Site | New Bern | North Carolina | 28562 | United States |
| Duramed Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| Duramed Investigational Site | Eugene | Oregon | 97401 | United States |
| Duramed Investigational Site | Medford | Oregon | 97504 | United States |
| Duramed Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Duramed Investigational Site | Philadelphia | Pennsylvania | 19114 | United States |
| Duramed Investigational Site | Pittsburgh | Pennsylvania | 15206 | United States |
| Duramed Investigational Site | Pottstown | Pennsylvania | 19464 | United States |
| Duramed Investigational Site | Columbia | South Carolina | 29201 | United States |
| Duramed Investigational Site | Hilton Head Island | South Carolina | 29926 | United States |
| Duramed Investigational Site | Jackson | Tennessee | 38305 | United States |
| Duramed Investigational Site | Houston | Texas | 77024 | United States |
| Duramed Investigational Site | Waco | Texas | 76712 | United States |
| Duramed Investigational Site | Williston | Vermont | 05495 | United States |
| Duramed Investigational Site | Norfolk | Virginia | 23507 | United States |
| Duramed Investigational Site | Seattle | Washington | 98105 | United States |
| Duramed Investigational Site | Tacoma | Washington | 98405 | United States |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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