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| ID | Type | Description | Link |
|---|---|---|---|
| 310802 | Other Identifier | Company internal |
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This study is examining a birth control patch for 13 cycles (1 year).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gestodene/EE Patch (BAY86-5016) | Drug | 55 mg ethinyl estradiol & 2.1 mg gestodene, 21 days for 13 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of pregnancy (yes/no) while on treatment | 13 treatment cycles each consisting of 28 days and follow-up period of 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Vital signs | 13 treatment cycles each consisting of 28 days | |
| Physical and gynecological examinations | 13 treatment cycles each consisting of 28 days | |
| Laboratory assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35235 | United States | |||
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| 13 treatment cycles each consisting of 28 days |
| Adverse events (AE monitoring) | 13 treatment cycles each consisting of 28 days |
| Glendale |
| Arizona |
| 85304 |
| United States |
| Precision Trials | Phoenix | Arizona | 85032 | United States |
| Visions Clinical Research - Tucson | Tucson | Arizona | 85712 | United States |
| Carmichael | California | 95608 | United States |
| Pacific Palisades | California | 90272 | United States |
| Paramount | California | 90723 | United States |
| Genesis Center for Clinical Research | San Diego | California | 92103 | United States |
| San Diego | California | 92108 | United States |
| San Diego | California | 92123 | United States |
| Santa Ana | California | 92705 | United States |
| Torrance | California | 90502 | United States |
| Denver | Colorado | 80218 | United States |
| Littleton | Colorado | 80122 | United States |
| New London | Connecticut | 06320 | United States |
| Visions Clinical Research | Boynton Beach | Florida | 33472-2952 | United States |
| Jacksonville | Florida | 32207 | United States |
| Miami | Florida | 33186 | United States |
| Pembroke Pines | Florida | 33024 | United States |
| Meridien Research | St. Petersburg | Florida | 33709 | United States |
| Atlanta | Georgia | 30328 | United States |
| Decatur | Georgia | 30034 | United States |
| Roswell | Georgia | 30075 | United States |
| Research Associates | Boise | Idaho | 83702 | United States |
| Rosemark Women Care Specialist | Idaho Falls | Idaho | 83404 | United States |
| Chicago | Illinois | 60612 | United States |
| Newburgh | Indiana | 47630 | United States |
| South Bend | Indiana | 46601 | United States |
| Marrero | Louisiana | 70072 | United States |
| Boston | Massachusetts | 02118 | United States |
| Chaska | Minnesota | 55318 | United States |
| Lincoln | Nebraska | 68510 | United States |
| Las Vegas | Nevada | 89030 | United States |
| Las Vegas | Nevada | 89106 | United States |
| Office of Dr. R. Garn Mabey, MD | Las Vegas | Nevada | 89128 | United States |
| Lawrenceville | New Jersey | 08648 | United States |
| Moorestown | New Jersey | 08057 | United States |
| Albuquerque | New Mexico | 87102 | United States |
| New York | New York | 10032 | United States |
| New Bern | North Carolina | 28562 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Cincinnati | Ohio | 45267-0457 | United States |
| Cleveland | Ohio | 44122 | United States |
| Columbus | Ohio | 43213 | United States |
| York Clinical Consulting | Oklahoma City | Oklahoma | 73120 | United States |
| Eugene | Oregon | 97401 | United States |
| Portland | Oregon | 97239-3011 | United States |
| Philadelphia | Pennsylvania | 19114 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Warwick | Rhode Island | 02886 | United States |
| Columbia | South Carolina | 29201 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Chattanooga | Tennessee | 37404 | United States |
| Knoxville | Tennessee | 37920 | United States |
| Women's Care Center, PLC | Memphis | Tennessee | 38119 | United States |
| Nashville | Tennessee | 37203 | United States |
| Nashville | Tennessee | 37205 | United States |
| Corpus Christi | Texas | 78414 | United States |
| Practice Research Organization | Dallas | Texas | 75230 | United States |
| Advances in Health, inc. | Houston | Texas | 77030 | United States |
| The Woman's Hospital of Texas | Houston | Texas | 77054 | United States |
| Norfolk | Virginia | 23507 | United States |
| Women's Clinical Research Center | Seattle | Washington | 98105 | United States |