Safety and Efficacy of Levonorgestrel 0.10 mg and Ethinyl Estradiol 0.02 mg plus Ethinyl Estradiol 0.01 mg in an Extended-Cycle Oral Contraceptive Regimen

Abstract

Extended-cycle combined hormonal contraception has become a common practice among women seeking effective contraception and menstrual regulation. Extended cycle regimens have the benefit of decreasing scheduled bleeding as compared to traditional combined oral contraceptive (COC) regimens containing 21 days of hormones followed by a 7-day hormone-free interval (HFI) by reducing the frequency of the HFI. The newest FDA approved product in this family of contraceptive regimens is a 91-day COC regimen containing 0.02 mg ethinyl estradiol (EE) and 0.1 mg levonorgestrel (LNG) for 84 days followed by a 7-day interval with 0.01 mg EE. This regimen has been evaluated in one pivotal trial and demonstrated to have efficacy and a side effect profile similar to the other currently available FDA approved 91-day extended-cycle regimens. This is the first 91-day regimen formulated with 0.02 mg EE and offers women an effective option for contraception and menstrual cycle control.