Safety and bleeding profile of continuous levonorgestrel 90 mcg/ethinyl estradiol 20 mcg based on 2 years of clinical trial data in Canada

Background The study was conducted to evaluate bleeding profile and safety of continuous oral contraceptive (OC) containing levonorgestrel (LNG) 90 mcg/ethinyl estradiol (EE) 20 mcg Study Design Healthy women who participated at seven Canadian sites in 1-year open-label study of LNG 90 mcg/EE 20 mcg daily were eligible for this second-year extension study Primary end points included bleeding profile and adverse events Results Seventy-nine women enrolled without interrupting pill taking, 62 (78 5%) completed Adverse events were comparable to cyclic OC regimens, except unscheduled vaginal bleeding Amenorrhea and absence of bleeding increased to about 80% and 90%, respectively by Pill Pack 18 Mean (median) number of bleeding days for the last two 90-day intervals was 1 1 (0) and 0 7 (0) days, respectively Conclusions Continuous LNG 90 mcg/EE 20 mcg had a safety profile similar to low-dose cyclic OCs Short-term safety profile remained excellent, with increasing rates of amenorrhea and decreasing incidence of unscheduled bleeding and/or spotting (C) 2010 Elsevier Inc All rights reserved