2011 International Conference on Family Planning
29 November–2 December 2011
"A Phase II, dose-finding, crossover study to evaluate the effect of a transdermal Nestorone®/estradiol (NES/E2) gel on ovulation suppression and assess acceptability in healthy ovulating women"
Ruth B. Merkatz, Daniel Mishell, Holger Kraus, Vivian Brache, Christian Jesam, Elena Hoskin, and Régine Sitruk-Ware
It is anticipated that user demand for contraceptive services in developing countries will increase by 40 percent (535–746 million) by 2025. Presently, more than 10 percent (225 million) of women report an unmet need for contraception, and 0.4 million women die in pregnancy and childbirth every year. To address this unmet need and its link to maternal mortality, the Population Council (PC) strives to develop contraceptive technologies that are safe, effective, acceptable, and accessible, and can support development, scale-up, financing, and sustainability of effective service delivery.
Program intervention/activity tested
The PC, in collaboration with Antares has developed a new gel delivery system comprised of Nestorone® (NES), a new progestin, and estradiol (E2). The goal is a family planning method that is safe, effective, easy to use and under the woman’s control. The specific aim of this research was to evaluate the effect of NES/E2 transdermal gel delivery on ovulation suppression and assess women’s reports on aspects of acceptability.
Methodology (location, setting, data source, time frame, intended beneficiaries, participant size, evaluation approach)
A crossover design was employed to evaluate the effects of the gel in 3 different doses in 18 women divided equally in three sites, i.e. in Chile, the Dominican Republic, and the United States. The primary objective was to determine the lowest effective dose required to suppress ovulation reliably in 90–95 percent of cycles. Using a phenomenologic approach, an open ended interview was administered at the end of the study to assess women’s experiences in using this novel contraceptive. Questions were posed regarding ease of use, partner responses, impressions about health effects and general satisfaction, and women’s willingness to purchase the product.
All doses of NES/E2 gel showed ovulation suppression. There was no apparent correlation of NES serum levels with BMI or body weight and there were no serious adverse events. For reasons to be described, the medium dose was selected for future studies to be conducted in larger populations. Results from the acceptability interviews revealed that participants found the gel easy to use and that it was absorbed quickly. Women reported that their partners were unaware of any effects from their use of the gel.
Results from early studies with a transdermal gel suggest this method offers promise as a new effective and acceptable hormonal contraceptive that is under a woman’s control and allows privacy of use. Since it contains natural estrogen (E2) rather than synthetic ethinyl estradiol, there may be safety advantages as well, specifically for lowering the risk of thrombosis.
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