The pharmacokinetic study was an open-label, randomized, comparative, single-center, two-period cross-over study with 39 patients that evaluated two contraceptive patches to see if the systemic exposure of ethinyl estradiol (EE) and levonorgestrel (LNG) were comparable to the low-dose oral contraceptive, LEVLEN®. As intended, both the EE and LNG exposure over time of both patches were less than LEVLEN® and consistent with the levels targeted by the company.




Study 11

In this multi-centered, multi-cycle Phase 2b safety and efficacy study of 123 women, the Company studied patches with different estrogen and progestin doses for three cycles to identify the regimen providing the best efficacy (as demonstrated by ovulation suppression), cycle control and tolerability at the lowest hormonal dose. Top-line results from the trial showed there was a clear dose response to ovulation suppression and cycle control. AG-200-15 provided the greatest ovulation suppression with the best cycle control of the three regimens studied.