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| ID | Type | Description | Link |
|---|---|---|---|
| 304742 | Other Identifier | Company internal |
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The purpose of this study is to determine whether the study drug is safe and effective in the prevention of pregnancies in a large group of volunteers.
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals Inc.. Bayer HealthCare Pharmaceuticals Inc. is the sponsor of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EV/DNG (Qlaira, BAY86-5027) | Experimental | Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV/DNG (Qlaira, BAY86-5027, SH T00658ID) | Drug | GA: Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral) Tablet, p.o. (oral) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of unintended pregnancies after 1 year | Throughout 1 year of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding pattern and cycle control parameters after 1 year | Throughout 1 year of treatment |
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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 |
|---|---|---|---|---|---|---|
| Women and Children's Hospital, Los Angeles | Los Angeles | California | 90033 | United States | ||
| Lifespan Research |
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| Palo Alto |
| California |
| 94301 |
| United States |
| Genesis Center for Clinical Research | San Diego | California | 92103 | United States |
| Medical Center for Clinical Research | San Diego | California | 92108 | United States |
| Harbor - UCLA Medical Center | Torrance | California | 90509 | United States |
| Clinical Trial Center of Colorado | Castle Rock | Colorado | 80108 | United States |
| New Age Medical Research Corp. | Miami | Florida | 33186 | United States |
| Visions Clinical Research | Palm Springs | Florida | 33461 | United States |
| Insignia Care for Women, P.A. | Tampa | Florida | 33607 | United States |
| Comprehensive Clinical Trials | West Palm Beach | Florida | 33409 | United States |
| Physicians Research Group | Indianapolis | Indiana | 46250 | United States |
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
| Women's Clinic of Lincoln, PC | Lincoln | Nebraska | 68510 | United States |
| Women's Care Source | Morristown | New Jersey | 07960 | United States |
| OB/GYN Health Center | Medford | Oregon | 97504 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Clinical Research of Philadelphia, LLC | Philadelphia | Pennsylvania | 19114 | United States |
| University of Pittsburgh Medical Center Health System | Pittsburgh | Pennsylvania | 15213-2582 | United States |
| Eastern Virginia Medical School | Norfolk | Virginia | 23507 | United States |
| Seattle Women's: Health, Research, Gynecology | Seattle | Washington | 98105 | United States |
| Total Concept Health Care Inc. | Kitchener | Ontario | N2C 2N9 | Canada |
| Temple Green Clinic | Waterloo | Ontario | N2L 6H6 | Canada |
| Rhodin Recherche Clinique | Drummondville | Quebec | J2B 1H8 | Canada |
| Centre d'étude clinique de Montréal Inc. | Montreal | Quebec | H1T 1P6 | Canada |
| Les Gynecologues Associes | Montreal | Quebec | H2X 1N8 | Canada |
| Clinique Recherche en Sante des Femmes Inc. | Québec | Quebec | G1S 2L6 | Canada |
| Clinique de Gynecologie | Shawinigan | Quebec | G9N 2H6 | Canada |
| Diex Recherche Inc. | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| Clinique Médicale des Campus | Ste-Foy | Quebec | G1V 4X7 | Canada |