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

Contraception. 2006 Mar;73(3):229-34. doi: 10.1016/j.contraception.2005.09.010. Epub 2005 Nov 2.

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 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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Contraceptives, Oral, Synthetic / administration & dosage
  • Contraceptives, Oral, Synthetic / pharmacology*
  • Drug Administration Schedule
  • Ethinyl Estradiol-Norgestrel Combination / administration & dosage
  • Ethinyl Estradiol-Norgestrel Combination / pharmacology*
  • Female
  • Humans
  • Menstrual Cycle / drug effects
  • Menstruation / drug effects
  • Pregnancy

Substances

  • Contraceptives, Oral, Synthetic
  • Seasonale
  • Ethinyl Estradiol-Norgestrel Combination