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Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Population Council |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00455156 |
The purpose of this study is to evaluate the one-year data on the contraceptive efficacy and safety of the 150/15 NES/EE CVR as the basis for regulatory approvals of this CVR as a new delivery system for contraception.
Condition | Intervention | Phase |
---|---|---|
Contraception |
Drug: 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Open-Label Study on the Efficacy, Cycle Control and Safety of a Contraceptive Vaginal Ring Delivering a Daily Dose of 150µg of Nestorone® and 15µg of Ethinyl Estradiol (150/15 NES/EE CVR) |
Estimated Enrollment: | 1200 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 39 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
California Family Health Council | |
Los Angeles, California, United States, 90010 | |
United States, Colorado | |
University of Colorado - Adv. Repro. Med. | |
Denver, Colorado, United States, 80010 | |
United States, Kentucky | |
University of Kentucky | |
Lexington, Kentucky, United States, 40536-0293 | |
United States, Maryland | |
Contraceptive Research and Programs | |
Baltimore, Maryland, United States, 21224 | |
United States, Massachusetts | |
Baystate Medical Center | |
Springfield, Massachusetts, United States, 01199 | |
United States, New York | |
NYU Medical Center Family Planning Division | |
New York, New York, United States, 10016 | |
Columbia University | |
New York, New York, United States, 10032 | |
United States, Ohio | |
MacDonald Physicians, Inc. | |
Cleveland, Ohio, United States, 44124 | |
University of Cincinnati College of Medicine | |
Cincinnati, Ohio, United States, 45267 | |
The Ohio State University | |
Columbus, Ohio, United States, 43210 | |
United States, Oregon | |
Oregon Health Sciences University | |
Portland, Oregon, United States, 97201 | |
United States, Pennsylvania | |
University of Pennsylvania Medical Center | |
Philadelphia, Pennsylvania, United States, 19104 | |
Magee-Womens Hospital | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Texas | |
UT Southwestern Medical Center; Division of Community Women's Health Care | |
Dallas, Texas, United States, 75235 | |
United States, Virginia | |
Jones Institute of Repro Medicine, EVMS | |
Norfolk, Virginia, United States, 23507 |
Study Director: | Diana L. Blithe, PH.D. | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Responsible Party: | National Institute of Child Health and Human Development ( Diana L. Blithe, PH.D., Study Director ) |
Study ID Numbers: | HHSN275200403366I, CCN006 |
Study First Received: | April 2, 2007 |
Last Updated: | June 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00455156 |
Health Authority: | United States: Food and Drug Administration |
Contraception Vaginal Ring |
ST 1435 Estradiol 3-benzoate Estradiol valerate Ethinyl Estradiol |
Estradiol 17 beta-cypionate Polyestradiol phosphate Estradiol |
Estrogens Contraceptive Agents Therapeutic Uses Physiological Effects of Drugs Contraceptive Agents, Female |
Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Hormones Pharmacologic Actions |