Contraception
Volume 82, Issue 6 , Pages 497-502, December 2010

Safety and bleeding profile of continuous levonorgestrel 90 mcg/ethinyl estradiol 20 mcg based on 2 years of clinical trial data in Canada☆☆☆

  • Robert L. Reid

      Affiliations

    • Department of Obstetrics and Gynecology, Queen's University, Kingston, Ontario, Canada K7L 4V7
    • Corresponding Author InformationCorresponding author. Division of REI, Department of Obstetrics and Gynecology, Queen's University, Kingston, Ontario, Canada K7L 4V7. Tel.: +1 613 542 9473; fax: +1 613 533 6779.
    • ,
  • Michel P. Fortier

      Affiliations

    • Clinique de Recherche en Santé des femmes, Québec, Québec, Canada G1S 2L6
    • ,
  • Lynne Smith

      Affiliations

    • Pfizer, Inc., Collegeville, PA 19101, USA
    • ,
  • Sebastian Mirkin

      Affiliations

    • Pfizer, Inc., Collegeville, PA 19101, USA
    • ,
  • Gary S. Grubb

      Affiliations

    • Wyeth Research (formerly), Collegeville, PA 19101, USA
    • ,
  • Ginger D. Constantine

      Affiliations

    • Wyeth Research (formerly), Collegeville, PA 19101, USA

Received 22 October 2009; received in revised form 1 June 2010; accepted 2 June 2010. published online 20 July 2010.

Abstract 

Background

The study was conducted to evaluate bleeding profile and safety of continuous oral contraceptive (OC) containing levonorgestrel (LNG) 90 mcg/ethinyl estradiol (EE) 20 mcg.

Study Design

Healthy women who participated at seven Canadian sites in 1-year open-label study of LNG 90 mcg/EE 20 mcg daily were eligible for this second-year extension study. Primary end points included bleeding profile and adverse events.

Results

Seventy-nine women enrolled without interrupting pill taking; 62 (78.5%) completed. Adverse events were comparable to cyclic OC regimens, except unscheduled vaginal bleeding. Amenorrhea and absence of bleeding increased to about 80% and 90%, respectively, by Pill Pack 18. Mean (median) number of bleeding days for the last two 90-day intervals was 1.1 (0) and 0.7 (0) days, respectively.

Conclusions

Continuous LNG 90 mcg/EE 20 mcg had a safety profile similar to low-dose cyclic OCs. Short-term safety profile remained excellent, with increasing rates of amenorrhea and decreasing incidence of unscheduled bleeding and/or spotting.

Keywords: Continuous oral contraceptive, Levonorgestrel, Ethinyl estradiol, Bleeding, Safety

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☆ clinicaltrials.gov Identifier: NCT00245921.

☆☆ This study was sponsored by Wyeth Research, which was acquired by Pfizer, Inc., in October 2009.

PII: S0010-7824(10)00355-0

doi:10.1016/j.contraception.2010.06.002

Contraception
Volume 82, Issue 6 , Pages 497-502, December 2010

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