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This is an open-label, single treatment study. All subjects will receive 6 months of oral contraceptive therapy with DR-1021. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.
The overall study duration for each patient will be approximately 8 months, which includes a screening period of approximately 4 weeks; a treatment period of approximately six months (six,28-day cycles); and a follow-up visit approximately 4 weeks after completion of study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DR-1021 | Drug | 1 tablet daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of pregnancy rates | Duration of study |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events reported by patients and investigators | Duration of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Duramed Medical Monitor | Duramed Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duramed Investigational Site | Huntsville | Alabama | 35801 | United States | ||
| Duramed Investigational Site |
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| Mobile |
| Alabama |
| 36608 |
| United States |
| Duramed Investigational Site | Phoenix | Arizona | 85015 | United States |
| Duramed Investigational Site | Phoenix | Arizona | 85031 | United States |
| Duramed Investigational Site | Carmichael | California | 95608 | United States |
| Duramed Investigational Site | Irvine | California | 92618 | United States |
| Duramed Investigational Site | San Diego | California | 92108 | United States |
| Duramed Investigational Site | San Diego | California | 92123 | United States |
| Duramed Investigational Site | San Ramon | California | 94583 | United States |
| Duramed Investigational Site | Colorado Springs | Colorado | 80909 | United States |
| Duramed Investigational Site | Lakewood | Colorado | 80228 | United States |
| Duramed Investigational Site | Wilmington | Delaware | 19805 | United States |
| Duramed Investigational Site | Washington D.C. | District of Columbia | 20006 | United States |
| Duramed Investigational Site | Aventura | Florida | 33180 | United States |
| Duramed Investigational Site | Boynton Beach | Florida | 33437 | United States |
| Duramed Investigational Site | Brooksville | Florida | 33613 | United States |
| Duramed Investigational Site | Clearwater | Florida | 33761 | United States |
| Duramed Investigational Site | Coral Gables | Florida | 33134 | United States |
| Duramed Investigational Site | Fort Meyers | Florida | 33918 | United States |
| Duramed Investigational Site | Leesburg | Florida | 34748 | United States |
| Duramed Investigational Site | Longwood | Florida | 32779 | United States |
| Duramed Investigational Site | Miami | Florida | 33173 | United States |
| Duramed Investigational Site | Pinellas Park | Florida | 33781 | United States |
| Duramed Investigational Site | Sarasota | Florida | 34239 | United States |
| Duramed Investigational Site | St. Petersburg | Florida | 33702 | United States |
| Duramed Investigational Site | St. Petersburg | Florida | 33709 | United States |
| Duramed Investigational Site | Tampa | Florida | 33613 | United States |
| Duramed Investigational Site | West Palm Beach | Florida | 33409 | United States |
| Duramed Investigational Site | Atlanta | Georgia | 30328 | United States |
| Duramed Investigational Site | Atlanta | Georgia | 30342 | United States |
| Duramed Investigational Site | Decatur | Georgia | 30034 | United States |
| Duramed Investigational Site | Roswell | Georgia | 30075 | United States |
| Duramed Investigational Site | Boise | Idaho | 83704 | United States |
| Duramed Investigational Site | Chicago | Illinois | 60611 | United States |
| Duramed Investigational Site | Chicago | Illinois | 60612 | United States |
| Duramed Investigational Site | Peoria | Illinois | 61602 | United States |
| Duramed Investigational Site | Shawnee Mission | Kansas | 66216 | United States |
| Duramed Investigational Site | Topeka | Kansas | 66614 | United States |
| Duramed Investigational Site | Lexington | Kentucky | 40509 | United States |
| Duramed Investigational Site | Louisville | Kentucky | 40291 | United States |
| Duramed Investigational Site | Mount Sterling | Kentucky | 40353 | United States |
| Duramed Investigational Site | Kansas City | Missouri | 64108 | United States |
| Duramed Investigational Site | Lincoln | Nebraska | 68510 | United States |
| Duramed Investigational Site | Las Vegas | Nevada | 89146 | 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 | Johnson City | New York | 13790 | United States |
| Duramed Investigational Site | Rochester | New York | 14609 | United States |
| Duramed Investigational Site | Charlotte | North Carolina | 28211 | United States |
| Duramed Investigational Site | Raleigh | North Carolina | 27612 | United States |
| Duramed Investigational Site | Wilmington | North Carolina | 28412 | United States |
| Duramed Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Duramed Investigational Site | Columbus | Ohio | 43210 | United States |
| Duramed Investigational Site | Columbus | Ohio | 43213 | United States |
| Duramed Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| Duramed Investigational Site | Medford | Oregon | 97504 | United States |
| Duramed Investigational Site | Philadelphia | Pennsylvania | 19114 | United States |
| Duramed Investigational Site | Reading | Pennsylvania | 19606 | United States |
| Duramed Investigational Site | Cranston | Rhode Island | 02920 | United States |
| Duramed Investigational Site | Greer | South Carolina | 29651 | United States |
| Duramed Investigational Site | Mt. Pleasant | South Carolina | 29464 | United States |
| Duramed Investigational Site | Bristol | Tennessee | 37620 | United States |
| Duramed Investigational Site | Chattanooga | Tennessee | 37404 | United States |
| Duramed Investigational Site | Clarksville | Tennessee | 37043 | United States |
| Duramed Investigational Site | Germantown | Tennessee | 38138 | United States |
| Duramed Investigational Site | Knoxville | Tennessee | 37920 | United States |
| Duramed Investigational Site | Nashville | Tennessee | 37203 | United States |
| Duramed Investigational Site | Austin | Texas | 78759 | United States |
| Duramed Investigational Site | Dallas | Texas | 75234 | United States |
| Duramed Investigational Site | Houston | Texas | 77030 | United States |
| Duramed Investigational Site | San Antonio | Texas | 78229 | United States |
| Duramed Investigational Site | Waco | Texas | 76712 | United States |
| Duramed Investigational Site | Magna | Utah | 84044 | United States |
| Duramed Investigational Site | Pleasant Grove | Utah | 84062 | United States |
| Duramed Investigational Site | Salt Lake City | Utah | 84124 | United States |
| Duramed Investigational Site | Sandy City | Utah | 84070 | United States |
| Duramed Investigational Site | Arlington | Virginia | 22203 | United States |
| Duramed Investigational Site | Newport News | Virginia | 23602 | United States |
| Duramed Investigational Site | Norfolk | Virginia | 23507 | United States |
| Duramed Investigational Site | Richmond | Virginia | 23233 | United States |
| Duramed Investigational Site | Lakewood | Washington | 98499 | United States |
| Duramed Investigational Site | Seattle | Washington | 98105 | United States |
| Duramed Investigational Site | Spokane | Washington | 99207 | United States |
| Duramed Investigational Site | Tacoma | Washington | 98405 | United States |