Contraception
Volume 73, Issue 3 , Pages 229-234, March 2006

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

  • Freedolph D. Anderson

      Affiliations

    • The Jones Institute for Reproductive Medicine, Eastern Virginia Medical School, Norfolk, VA 23507-1627, USA
    • Corresponding Author InformationCorresponding author. 1223 Lawson Cove Circle, Virginia Beach, VA 23455-6826, USA.
  • ,
  • William Gibbons

      Affiliations

    • The Jones Institute for Reproductive Medicine, Eastern Virginia Medical School, Norfolk, VA 23507-1627, USA
  • ,
  • David Portman

      Affiliations

    • Columbus Center for Women's Health Research, Columbus, OH 43213-1562, USA

Received 3 May 2005; received in revised form 1 September 2005; accepted 6 September 2005. published online 02 November 2005.

Abstract 

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 μg EE/150 μg levonorgestrel (LNG)] for 84 days followed by EE 10 μg 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.

Keywords: Seasonique™, Extended regimen, Oral contraceptive, Ethinyl estradiol, Pregnancy

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PII: S0010-7824(05)00366-5

doi:10.1016/j.contraception.2005.09.010

Contraception
Volume 73, Issue 3 , Pages 229-234, March 2006