Use of a novel transdermal contraceptive patch suppresses ovulation in obese and nonobese women, research shows.
The effect of the patch on ovarian activity was dose dependent, with the highest doses of ethinyl estradiol (EE) and levonorgestrel (LNG) preventing progesterone increases in all women.
With AG200-15, the highest-dose transdermal patch containing 120 mcg/day LNG with 30 mcg/day EE, progesterone levels did not increased above 3 ng/ml during the normal luteal phase of treatment cycles 2 and 3 in obese or nonobese women.
The lack of increase in progesterone levels associated with ovulation in cycles 2 and 3 "indicates that there is a similar contraceptive effect in both obese and nonobese women," report researchers in Contraception.
Led by Marie Foegh (Agile Therapeutics, Princeton, New Jersey, USA), the phase II study included 41 obese women (body mass index >30 kg/m2) and 75 nonobese women.
Previous studies, including an analysis of 53,000 women taking oral contraceptives, found a higher risk for pregnancy in obese women compared with nonobese women.
In the present study, three doses of the transdermal patch were used: the high-dose AG200-15 patch; AG200-12.5, which contained 100 mcg/day LNG with 25 mcg/day EE; and AG200LE, a low-dose patch containing 75 mcg LNG and 15 mcg/day EE.
The median concentrations of EE and LNG did not differ significantly between the obese and nonobese women treated with any of the transdermal patches doses used in the study. The mean levels tended to be lower in obese women, but the difference between obese and nonobese women was not statistically significant.
Overall, none of the obese women treated with middle-dose AG200-12.5 had progesterone levels indicative of ovulation, while there was no ovarian activity in the nonobese women treated with AG200-12.5.
With the highest-dose patch, there appeared to be a similar contraceptive effect in the obese and nonobese women, with a similar lack of an increase in progesterone associated with ovulation in cycles 2 and 3.
"All three patch doses were associated with some ovarian activity during cycle days 1 to 14, with more activity in obese compared with nonobese subjects in the AG200-15 group," report Foegh and colleagues.
A larger phase III study is currently underway testing the risk for pregnancy with AG200-15 in obese and nonobese women.
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