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Sponsors and Collaborators: |
Population Council US Agency for International Development Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) World Health Organization |
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Information provided by: | Population Council |
ClinicalTrials.gov Identifier: | NCT00263341 |
The purpose of this 1-year study is to evaluate the efficacy and safety of a new contraceptive vaginal ring (CVR) delivering low doses of Nestorone (NES), a new, nonandrogenic progestin, and ethinyl estradiol (EE), an estrogen used in oral contraceptives. The CVR, which is made of silicone rubber, is designed to be used for 1 year (13 menstrual cycles) before replacement is required.
Condition | Intervention | Phase |
---|---|---|
Contraception |
Drug: 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 150 ug of Nestorone® and 15 ug of Ethinyl Estradiol |
Estimated Enrollment: | 1000 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | June 2009 |
The objective of this study is to evaluate the contraceptive efficacy, cycle control, and safety of a reusable CVR delivering low daily doses of NES and EE for a 1-year (13-cycle) period.
Nestorone is a potent, nonandrogenic, 19-norprogesterone derivative, which is not active when given orally, but is highly active when delivered via non-oral delivery systems, such as CVRs, implants, or transdermal preparations. The high potency of NES makes it an excellent candidate for use in contraceptive delivery systems designed to be effective for prolonged periods. This characteristic of Nestorone has been utilized in the design of a contraceptive vaginal ring that releases low daily doses of both NES and EE and is effective for a 1-year (13-cycle) period. The NES/EE vaginal ring is a long-acting contraceptive device, but, unlike other long-term methods, it use is controlled by the woman without the need for medical intervention.
The efficacy of NES/EE vaginal ring in preventing pregnancy during a 1-year (13-cycle) period will be studied in women who have regular sexual activity and use no other form of contraception. The Pearl index for all women (18-<40) and Kaplan-Meier life table analyses will be assessed for all subjects and for subjects £ 35 years and will provide supportive analyses for demonstrating efficacy. Pearl indices will be based on all cycles and on all cycles for which back-up contraception is not used.
The number of bleeding/spotting days per cycle or reference period will be used to evaluate cycle control. Safety will be evaluated by regular assessments of blood pressure, pulse, and body weight and by laboratory testing and Pap smears at screening and termination, and by the frequencies of adverse events and serious adverse events. Additional safety evaluations will be obtained in a companion Phase 3 study conducted by the NIH (Protocol CCN006) with three substudies to evaluate 1) the effect of treatment on 4 hepatic proteins that may be associated with a risk for thromboembolism; 2) the effect of reusing the same CVR for 13 consecutive cycles on vaginal flora and the risk of infection; and 3) the effect of vaginal delivery of NES and EE on the endometrium.
A nested pharmacokinetics/pharmacodynamics/safety study is also being conducted in a subset of 39 patients. Blood samples are drawn during study cycles 1, 3, and 13 in order to assess ovulation suppression, measured by serum progesterone concentration, and the pharmacokinetics of NES and EE.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Healthy women who meet the following criteria:
[For pharmacokinetics study only; 39 subjects already recruited]
- Willing to undergo frequent blooding sampling
Exclusion Criteria:
Contraindications for enrollment will be the same as those for use with combined hormonal contraceptives in addition to contraindications specific to this clinical trial including:
United States, California | |
Women and Children's Hospital, LAC/USC Medical Center | |
Los Angeles, California, United States, 90033 | |
University of California, San Francisco General Hospital, Department of Obstetrics & Gynecology | |
San Francisco, California, United States, 94110 | |
United States, Illinois | |
University of Chicago Hospitals | |
Chicago, Illinois, United States, 60637 | |
United States, New York | |
Montefiore Medical Center/Albert Einstein College of Medicine | |
Bronx, New York, United States, 10461 | |
United States, Ohio | |
Columbus Center for Women's Heatlh Research | |
Columbus, Ohio, United States, 43213 | |
Australia | |
FPA Health | |
Ashfield, Australia | |
Brazil | |
University of Campinas, Department of Obstetrics & Gynecology | |
Campinas, Sao Paulo, Brazil | |
Chile | |
Instituto Chileno de Medicina Reproductiva | |
Santiago, Chile | |
Dominican Republic | |
PROFAMILIA | |
Santo Domingo, Dominican Republic | |
Finland | |
Family Federation of Finland | |
Helsinki, Finland | |
Hungary | |
University of Szeged, Department of Obstetrics & Gynecology | |
Szeged, Hungary | |
Sweden | |
Karolinska Institutet, Department of Woman and Child Health, Division of Obstetrics & Gynecology | |
Stockholm, Sweden, SE 17176 |
Study Director: | Ruth Merkatz, Ph.D. | Population Council |
Study ID Numbers: | Protocol 300 |
Study First Received: | December 6, 2005 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00263341 |
Health Authority: | United States: Food and Drug Administration |
Contraceptive agents Female contraception Progestins |
ST 1435 Estradiol 3-benzoate Estradiol valerate Ethinyl Estradiol |
Estradiol 17 beta-cypionate Polyestradiol phosphate Estradiol |
Estrogens Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions |