Contraception Clinical Trial
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
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.
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.
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