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Progestin-only contraceptive rings.
V Brache1, F Alvarez-Sanchez, A Faundes
1PROFAMILIA Inc., Biomedical Research Department, P.O. Box 1053, Santo Domingo, Dominican Republic. biomedica@codetel.net.do
Steroids
|December 8, 2000
Summary
Vaginal rings offer a user-controlled, long-acting contraceptive option. While levonorgestrel rings showed a 4.5% one-year pregnancy rate, Nestorone rings demonstrated high ovulation inhibition and zero pregnancies in a low-dose group.
Area of Science:
- Reproductive Health
- Contraception
- Pharmacology
Background:
- Long-acting progestin-only contraceptives include implants and injectables.
- Vaginal rings represent a novel, user-controlled contraceptive delivery system in late-stage development.
- These devices offer constant drug release, enabling lower effective doses and non-coital, non-provider-dependent use.
Purpose of the Study:
- To review the development and clinical performance of progestin-only vaginal rings.
- To evaluate pregnancy rates, discontinuation reasons, and side effects associated with levonorgestrel and Nestorone vaginal rings.
Main Methods:
- Review of clinical trials, including a WHO-coordinated Phase III multicenter trial for a levonorgestrel ring (20 microg/day).
- Evaluation of a Nestorone vaginal ring study assessing ovulation inhibition and pregnancy rates at different release rates (50, 75, 100 microg/day) over six months.
- Analysis of reasons for discontinuation and reported adverse events.
Main Results:
- The levonorgestrel ring demonstrated a cumulative one-year pregnancy rate of 4.5%, with menstrual disturbances and ring expulsion as primary discontinuation reasons.
- Nestorone rings achieved over 97% ovulation inhibition.
- Six-month cumulative pregnancy rates for Nestorone rings were 0.0% (low-dose), 1.9% (intermediate-dose), and 2.1% (high-dose), with bleeding irregularities being common.
Conclusions:
- Vaginal rings are a promising long-acting contraceptive method with varying efficacy and side effect profiles.
- Further development, including more flexible devices and optimized release rates, is ongoing.
- Nestorone vaginal rings show potential, particularly for lactating women due to their oral inactivity.