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The purpose of this study is to determine whether NEA TDS is effective in the prevention of pregnancy. The safety of this product will also be evaluated.
An Open Label Study to Evaluate the Contraceptive Efficacy and Safety of Norethindrone Acetate Transdermal Delivery System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment | Experimental | Norethindrone Acetate Transdermal Delivery System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norethindrone Acetate | Drug | Norethindrone Acetate Transdermal Delivery System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy Rate | The pregnancy rate will be calculated using the Pearl Index that defined as 1300*Number of pregnancies/Number of cycles of treatment. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim E Caramelli, MS | Watson Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Watson Investigational Site | Birmingham | Alabama | United States | |||
| Watson Investigational Site |
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| Mobile |
| Alabama |
| United States |
| Watson Investigational Site | Montgomery | Alabama | United States |
| Watson Investigational Site | Chandler | Arizona | United States |
| Watson Investigational Site | Little Rock | Arkansas | United States |
| Watson Investigational Site | Garden Grove | California | United States |
| Watson Investigational Site | La Mesa | California | United States |
| Watson Investigational Site | San Diego | California | United States |
| Watson Investigational Site | Denver | Colorado | United States |
| Watson Investigational Site | Newark | Delaware | United States |
| Watson Investigational Site | Washington D.C. | District of Columbia | United States |
| Watson Investigational Site | Aventura | Florida | United States |
| Watson Investigational Site | Daytona Beach | Florida | United States |
| Watson Investigational Site | Jacksonville | Florida | United States |
| Watson Investigational Site | Lake Worth | Florida | United States |
| Watson Investigational Site | Miami | Florida | United States |
| Watson Investigational Site | North Miami | Florida | United States |
| Watson Investigational Site | Pinellas Park | Florida | United States |
| Watson Investigational Site | Sarasota | Florida | United States |
| Watson Investigational Site | Atlanta | Georgia | United States |
| Watson Investigational Site | Decatur | Georgia | United States |
| Watson Investigational Site | Sandy Springs | Georgia | United States |
| Watson Investigational Site | Savannah | Georgia | United States |
| Watson Investigational Site | Chicago | Illinois | United States |
| Watson Investigational Site | Overland Park | Kansas | United States |
| Watson Investigational Site | Marrero | Louisiana | United States |
| Watson Investigational Site | New Orleans | Louisiana | United States |
| Watson Investigational Site | Haverhill | Massachusetts | United States |
| Watson Investigational Site | Ann Arbor | Michigan | United States |
| Watson Investigational Site | Kalamazoo | Michigan | United States |
| Watson Investigational Site | Edina | Minnesota | United States |
| Watson Investigational Site | Las Vegas | Nevada | United States |
| Watson Investigational Site | Lawrenceville | New Jersey | United States |
| Watson Investigational Site | Albuquerque | New Mexico | United States |
| Watson Investigational Site | New York | New York | United States |
| Watson Investigational Site | Chapel Hill | North Carolina | United States |
| Watson Investigational Site | New Bern | North Carolina | United States |
| Watson Investigational Site | Raleigh | North Carolina | United States |
| Watson Investigational Site | Cleveland | Ohio | United States |
| Watson Investigational Site | Columbus | Ohio | United States |
| Watson Investigational Site | Medford | Oregon | United States |
| Watson Investigational Site | Philadelphia | Pennsylvania | United States |
| Watson Investigational Site | Columbia | South Carolina | United States |
| Watson Investigational Site | Greer | South Carolina | United States |
| Watson Investigational Site | Hilton Head Island | South Carolina | United States |
| Watson Investigational Site | Nashville | Tennessee | United States |
| Watson Investigational Site | Austin | Texas | United States |
| Watson Investigational Site | Dallas | Texas | United States |
| Watson Investigational Site | Houston | Texas | United States |
| Watson Investigational Site | San Antonio | Texas | United States |
| Watson Investigational Site | Salt Lake City | Utah | United States |
| Watson Investigational Site | Norfolk | Virginia | United States |
| Watson Investigational Site | Seattle | Washington | United States |
| ID | Term |
|---|---|
| D003268 | Contraception Behavior |
| ID | Term |
|---|---|
| D043762 | Reproductive Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000077563 | Norethindrone Acetate |
| ID | Term |
|---|---|
| D009640 | Norethindrone |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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