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Ovarian activity in obese and nonobese women treated with three transdermal contraceptive patches delivering three different doses of ethinyl estradiol and levonorgestrel
Authors:Marie Foegh  David F. Archer  Frank Z. Stanczyk  Arkady Rubin  Daniel R. Mishell
Affiliation:1. Agile Therapeutics, Princeton, NJ 08540, USA;2. Department of Obstetrics and Gynecology, Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA 23507, USA;3. Department of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California, Los Angeles, CA 90033, USA
Abstract:BackgroundThe effect of obesity on ovarian follicular suppression in women using low-estrogen dose contraceptive patches has not been determined.Study DesignA Phase II, parallel-group, multicenter, three-cycle study evaluated three patches containing different ethinyl estradiol (EE) and levonorgestrel (LNG) doses. Serum levels of EE, LNG, sex hormone-binding globulin and progesterone were compared in 41 obese [body mass index (BMI) ≥ 30] and 75 nonobese (BMI < 30) women.ResultsSuppression of ovulation during the luteal phase was dose dependent, with the highest dose (AG200-15) preventing progesterone increases in all women (cycles 2–3). In the follicular phase, the lowest-dose patch had the highest rate of increased progesterone in nonobese subjects. Progesterone levels ≥ 3.0 ng/mL in the follicular phase were more common in obese than nonobese women.ConclusionsAG200-15 suppresses ovulation in obese and nonobese women. All three patches found increased progesterone in the follicular phase, albeit more in obese versus nonobese women.
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