Safety and efficacy of an extended-regimen oral contraceptive utilizing continuous low-dose ethinyl estradiol.

OBJECTIVE

To assess the efficacy and safety of Seasonique, a 91-day extended-regimen oral contraceptive (OC) utilizing continuous low-dose ethinyl estradiol (EE) during the typical hormone-free interval.

METHODS

A multicenter, open-label, 1-year study of Seasonique [30 microg EE/150 microg levonorgestrel (LNG)] for 84 days followed by EE 10 microg for 7 days was conducted in sexually active, adult women of childbearing potential. All patients completed daily electronic diaries to monitor compliance and bleeding.

RESULTS

Method failure rate was 0.78 (Pearl index) and 0.64% (life table analysis). Cycle control and safety of the regimen were similar to that reported for other OCs.

CONCLUSION

This study demonstrates that Seasonique is effective, safe and well tolerated for the prevention of pregnancy.