Long-term safety of an extended regimen oral contraceptive (seasonale): a 2-year multicenter open-label trial

Abstract

Introduction: The efficacy and safety of the 91-day extended-regimen oral contraceptive (OC) Seasonale (84 days ethinyl estradiol/150 ��g levonorgestrel followed by 7 days placebo) has been demonstrated for up to 1 year (four cycles) (Anderson 2003) This study was undertaken to evaluate the long-term safety of Seasonale in women desiring pregnancy prevention.Materials and Methods: Following completion of the initial trial, 189 patients from selected centers received Seasonale for up to an additional 2 years (eight extended cycles). Patients recorded pill-taking and bleeding/spotting daily in electronic diaries and were evaluated during quarterly clinic visits.Results: Patient exposure included 1130 completed 91-day cycles. Overall rates of study discontinuation and the incidence of adverse events were similar to the earlier trial. No thromboembolic events were reported. Fewer days of bleeding and/or spotting were reported than in the earlier trial, and there was a reduction in the total number of bleeding and/or spotting days during the course of the 2-year study.Discussion: This is the first long-term study of an extended-regimen OC. The incidence of adverse events reported did not change with long-term use and was typical of OC therapy. As in the earlier trial, the number of days of unscheduled bleeding and/or spotting diminished during the course of the study with a median of 0 days of unscheduled bleeding reported per cycle.Conclusion: This study confirms the findings from the 1-year study and demonstrates that Seasonale is safe, effective and well tolerated. Introduction: The efficacy and safety of the 91-day extended-regimen oral contraceptive (OC) Seasonale (84 days ethinyl estradiol/150 ��g levonorgestrel followed by 7 days placebo) has been demonstrated for up to 1 year (four cycles) (Anderson 2003) This study was undertaken to evaluate the long-term safety of Seasonale in women desiring pregnancy prevention. Materials and Methods: Following completion of the initial trial, 189 patients from selected centers received Seasonale for up to an additional 2 years (eight extended cycles). Patients recorded pill-taking and bleeding/spotting daily in electronic diaries and were evaluated during quarterly clinic visits. Results: Patient exposure included 1130 completed 91-day cycles. Overall rates of study discontinuation and the incidence of adverse events were similar to the earlier trial. No thromboembolic events were reported. Fewer days of bleeding and/or spotting were reported than in the earlier trial, and there was a reduction in the total number of bleeding and/or spotting days during the course of the 2-year study. Discussion: This is the first long-term study of an extended-regimen OC. The incidence of adverse events reported did not change with long-term use and was typical of OC therapy. As in the earlier trial, the number of days of unscheduled bleeding and/or spotting diminished during the course of the study with a median of 0 days of unscheduled bleeding reported per cycle. Conclusion: This study confirms the findings from the 1-year study and demonstrates that Seasonale is safe, effective and well tolerated.