A multicenter, randomized study of an extended cycle oral contraceptive

Objective: To assess the efficacy and safety of Seasonale(R), 91-day extended cycle oral contraceptive (OC). Methods: A parallel, randomized, multicenter open-label, 1-year study of the OC Seasonale [30 mug ethinyl estradiol (EE)/150 mug levonorgestrel (LNG), and Nordette-28 (30 mug EE/150 mug LNG)] in sexually active, adult women (18-40 years) of childbearing potential. Patients received either four 91-day cycles of extended cycle regimen OC, or 13 cycles of the conventional 28-day OC with daily monitoring of compliance and bleeding via electronic diaries. Results: When taken daily for 84 days followed by 7 days of placebo, the extended cycle regimen was effective in preventing pregnancy and had a safety profile that was comparable to that observed with the 28-day OC regimen that served as the control. While unscheduled (breakthrough) bleeding was reported among patients treated with the extended cycle regimen, it decreased with each successive cycle of therapy and was comparable to that reported by patients who received the conventional OC regimen by the fourth extended cycle Conclusion: This study demonstrated that Seasonale, 91-day extended cycle OC containing 84 days of 30 mug EE/150 mug LNG followed by 7 days of placebo, was effective, safe and well tolerated. (C) 2003 Elsevier. All rights reserved.