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.