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Sponsored by: |
Population Council |
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Information provided by: | Population Council |
ClinicalTrials.gov Identifier: | NCT00791297 |
The purpose of this study is to to determine pharmacodynamic effects of a vaginal ring delivering either 1,500 or 2,500 μg of CDB-2914 per day during 6 months of treatment on:
Condition | Intervention | Phase |
---|---|---|
Contraception |
Drug: CDB-2914 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Randomized Study to Evaluate the Safety and Efficacy of Two Contraceptive Vaginal Rings Delivering a Daily Dose of 1500 or 2500 μg of CDB-2914 on Inhibition of Ovulation, Endometrial Changes and Bleeding Patterns in Normal Cycling Women |
Estimated Enrollment: | 60 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Contraceptive Vaginal Ring delivering a daily dose of 1500 μg of CDB-2914
|
Drug: CDB-2914
Contraceptive Vaginal Rings delivering a daily dose of 1500 or 2500 μg of CDB-2914
|
2: Active Comparator
Contraceptive Vaginal Ring delivering a daily dose of 2500 μg of CDB-2914
|
Drug: CDB-2914
Contraceptive Vaginal Rings delivering a daily dose of 1500 or 2500 μg of CDB-2914
|
Ages Eligible for Study: | 21 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Regine Sitruk-Ware | 212-327-7045 | rsitrukware@popcouncil.org |
Contact: Ruth Merkatz | 212-327-8647 | rmerkatz@popcouncil.org |
United States, Oregon | |
Oregon Health & Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Jeffrey Jensen, MD, MPH 503-494-5113 jensenje@ohsu.edu | |
Principal Investigator: Jeffrey Jensen, MD, MPH | |
Chile | |
Instituto Chileno de Medicina Reproductiva | Recruiting |
Santiago, Chile | |
Contact: Horacio Croxatto, MD 011-56-2-632 7788 hcroxatto@icmer.org | |
Principal Investigator: Horacio Croxatto, MD | |
Dominican Republic | |
PROFAMILIA | Recruiting |
Santo Domingo, Dominican Republic | |
Contact: Vivian Brache, Lic. 809-681-8357 biomedica@codetel.net.do | |
Principal Investigator: Vivian Brache, Lic. |
Responsible Party: | Population Council ( Regine Sitruk-Ware, Study Coordinator ) |
Study ID Numbers: | Population Council #422 |
Study First Received: | November 13, 2008 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00791297 |
Health Authority: | United States: Food and Drug Administration |
CDB-2914 Contraceptive Vaginal Rings ovulation endometrial changes |
bleeding patterns normal cycling women Inhibition of ovulation, endometrial changes and bleeding patterns in normal cycling women |
Hemorrhage |