Dose-finding trial reveals effectiveness of contraceptive gel
MedWire News: The results of a phase II, dose-finding trial show that a transdermal contraceptive gel combining two pregnancy-preventing hormones is both effective and well tolerated.
Ruth Merkatz (The Population Council, New York, USA) and colleagues believe the gel could offer women an alternative to the combined oral contraceptive pill.
Eighteen women from Chile, the Dominican Republic, and the USA received a daily dose of the gel which contains Nestorone-estradiol (NES/E2) for 7 months. The gel was applied to the abdomen in one of three doses: high (4.5 mg NES/1.5 mg E2), medium (3.0 mg NES/1.0 mg E2), and low (1.5 mg NES, 0.5 E2).
All doses of the gel resulted in ovarian suppression, and none of the women fell pregnant during the study.
The high dose resulted in NES/E2 levels above the target, while the low dose failed to completely suppress follicle growth (as expressed by high serum E2 levels).
The medium dose however, led to stable E2 levels and low numbers of large follicles, and was selected as the lowest effective dose.
The women reported minimal breakthrough bleeding, few side effects, and found the gel easy to remember to use.
"It's in early-stage development, but if we move on, we will obviously test it in many, many more women," commented Merkatz.
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By Sarah Guy