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This is a multicenter study to evaluate the efficacy and safety of 2 different doses of DR-3001. For eligible subjects the duration of the study will be approximately 20 weeks; this will consist of a 4-week screening period, a 12-week treatment period and a 4-week follow-up period. Subjects will have physical and laboratory exams, including blood draws at each scheduled visit. Subjects will be required to insert a vaginal ring (replacing it every 4 weeks) and to keep a daily record of their toilet voids (including time,type and volume) for 3 days at several specified time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DR-3001 | Drug | 4mg/day vaginal ring inserted vaginally and replaced every 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in total weekly number of incontinence (urge and stress)episodes | Baseline to end-of-treamtent (Week 12/Early withdrawal) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in average daily urinary frequency and average void volume | Baseline to end-of-treamtent (Week 12/Early withdrawal) | |
| Proportion of subjects with no incontinence episodes recorded in the final 3-day diary | Final 3-day diary |
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Inclusion Criteria:
Exclusion 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 | Huntsville | Alabama | 35801 | United States | ||
| Duramed Investigational Site |
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| DR-3001 | Drug | 6mg/day vaginal ring inserted vaginally and replaced every 4 weeks |
|
|
| Placebo | Drug | Placebo vaginal ring inserted vaginally and replaced every 4 weeks |
|
| 3 subject-reported outcome measures: visual analogue scale of OAB symptoms, Urogenital Distress Inventory, Incontinence Impact Question | Baseline to end-of-treatment (Week 12/Early Withdrawal) |
| Adverse events (AEs) reported by subjects or identified by the investigator | Basline to end-of-treatment (Week 12/Early Withdrawal) |
| Mobile |
| Alabama |
| 36608 |
| United States |
| Duramed Investigational Site | Montgomery | Alabama | 36116 | United States |
| Duramed Investigational Site | Phoenix | Arizona | 85015 | United States |
| Duramed Investigational Site | Tucson | Arizona | 85712 | United States |
| Duramed Investigational Site | Tucson | Arizona | 85741 | United States |
| Duramed Investigational Site | Little Rock | Arkansas | 72205 | United States |
| Duramed Investigational Site | Encinitas | California | 92024 | United States |
| Duramed Investigational Site | Los Angeles | California | 90036 | United States |
| Duramed Investigational Site | San Diego | California | 92103 | United States |
| Duramed Investigational Site | San Diego | California | 92108 | United States |
| Duramed Investigational Site | San Diego | California | 92123 | United States |
| Duramed Investigational Site | Colorado Springs | Colorado | 80909 | United States |
| Duramed Investigational Site | Denver | Colorado | 80220 | United States |
| Duramed Investigational Site | Danbury | Connecticut | 06810 | United States |
| Duramed Investigational Site | Milford | Connecticut | 06460 | United States |
| Duramed Investigational Site | New London | Connecticut | 06320 | United States |
| Duramed Investigational Site | Aventura | Florida | 33180 | United States |
| Duramed Investigational Site | Gainesville | Florida | 32607 | United States |
| Duramed Investigational Site | Jacksonville | Florida | 32207 | United States |
| Duramed Investigational Site | Miami | Florida | 33143 | United States |
| Duramed Investigational Site | New Port Richey | Florida | 34655 | United States |
| Duramed Investigational Site | Tampa | Florida | 33607 | United States |
| Duramed Investigational Site | West Palm Beach | Florida | 33407 | United States |
| Duramed Investigational Site | West Palm Beach | Florida | 33409 | United States |
| Duramed Investigational Site | Atlanta | Georgia | 30308 | United States |
| Duramed Investigational Site | Augusta | Georgia | 30901 | United States |
| Duramed Investigation Site | Decatur | Georgia | 30034 | United States |
| Duramed Investigational Site | Savannah | Georgia | 31406 | United States |
| Duramed Investigational Site | Boise | Idaho | 83704 | United States |
| Duramed Investigational Site | Boise | Idaho | 83712 | United States |
| Duramed Investigational Site | Coeur d'Alene | Idaho | 83814 | United States |
| Duramed Investigational Site | Meridian | Idaho | 83642 | United States |
| Duramed Investigational Site | Fort Wayne | Indiana | 46825 | United States |
| Duramed Investigational Site | Jeffersonville | Indiana | 47130 | United States |
| Duramed Investigational Site | South Bend | Indiana | 46601 | United States |
| Duramed Investigational Site | Newton | Kansas | 67114 | United States |
| Duramed Investigational Site | Wichita | Kansas | 67207 | United States |
| Duramed Investigational Site | Louisville | Kentucky | 40291 | United States |
| Duramed Investigational Site | Lafayette | Louisiana | 70503 | United States |
| Duramed Investigational Site | Marrero | Louisiana | 70072 | United States |
| Duramed Investigational Site | Shreveport | Louisiana | 71106 | United States |
| Duramed Investigational Site | Watertown | Massachusetts | 02472 | United States |
| Duramed Investigational Site | Las Vegas | Nevada | 89109 | United States |
| Duramed Investigational Site | Las Vegas | Nevada | 89128 | United States |
| Duramed Investigational Site | North Las Vegas | Nevada | 89030 | United States |
| Duramed Investigational Site | Lebanon | New Hampshire | 03756 | United States |
| Duramed Investigational Site | Lawrenceville | New Jersey | 08648 | United States |
| Duramed Investigational Site | Moorestown | New Jersey | 08057 | United States |
| Duramed Investigational Site | New Brunswick | New Jersey | 08901 | 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 | Winston-Salem | North Carolina | 27103 | United States |
| Duramed Investigational Site | Cleveland | Ohio | 44122 | United States |
| Duramed Investigational Site | Mayfield Heights | Ohio | 44124 | United States |
| Duramed Investigational Site | Bethany | Oklahoma | 73008 | 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 | Charlestown | South Carolina | 29425 | United States |
| Duramed Investigational Site | Columbia | South Carolina | 29201 | United States |
| Duramed Investigational Site | Greensville | South Carolina | 29605 | United States |
| Duramed Investigational Site | Hilton Head Island | South Carolina | 29926 | United States |
| Duramed Investigational Site | Jackson | Tennessee | 38305 | United States |
| Duramed Investigational Site | Dallas | Texas | 75234 | United States |
| Duramed Investigational Site | Dallas | Texas | 75390 | United States |
| Duramed Investigational Site | Dallas | Texas | 78229 | United States |
| Duramed Investigational Site | Houston | Texas | 77024 | United States |
| Duramed Investigational Site | San Antonio | Texas | 78209 | United States |
| Duramed Investigational Site | San Antonio | Texas | 78229 | United States |
| Duramed Investigational Site | Waco | Texas | 76712 | United States |
| Duramed Investigational Site | Salt Lake City | Utah | 84107 | 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 |
| Duramed Investigatinal Site | Vancouver | British Columbia | V6T 2B5 | Canada |
| Duramed Investigational Site | Oshawa | Ontario | L1H 7K4 | Canada |
| Duramed Investigational Site | Thunder Bay | Ontario | P7E 6E7 | Canada |
| 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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