Long-term safety of an extended-cycle oral contraceptive (Seasonale): A 2-year multicenter open-label extension trial

Objective: The purpose of this study was to assess the long-term safety of Seasonale, 91-day extended-cycle oral contraceptive (OC). Study design: Following completion of a 1-year Phase 3 multicenter trial, patients from selected centers were invited to participate in this 2-year extension trial. In this open-label study all participants received the 91-day extended-regimen OC, Seasonale. Results: There were 189 study participants enrolled from 27 sites. Patient exposure included 1130 completed 91-day cycles. Overall rates of study discontinuation and the incidence of adverse events were similar to the earlier Phase 3 clinical trial. Seasonale was well tolerated and the number of reported bleeding and/or spotting days reported diminished during the course of the study. Conclusion: This study confirms the findings from the previous clinical trial and demonstrates that Seasonale is a safe and effective therapy for long-term use. (c) 2006 Mosby, Inc. All rights reserved.