Contraception
Volume 77, Issue 1 , Pages 34-39, January 2008

Effects on serum hormone levels of low-dose estrogen in place of placebo during the hormone-free interval of an oral contraceptive

  • Kathleen Z. Reape

      Affiliations

    • Duramed Research, Inc. Bala Cynwyd, PA 19004, USA
    • Corresponding Author InformationCorresponding author. Tel.: +1 610 747 2641; fax: +1 610 747 6638.
  • ,
  • Charles E. DiLiberti

      Affiliations

    • Barr Laboratories, Woodcliff Lake, NJ 07677, USA
  • ,
  • Christopher H. Hendy

      Affiliations

    • Novum Pharmaceutical Research Services, Pittsburgh, PA 15206, USA
  • ,
  • Edward J. Volpe

      Affiliations

    • Duramed Research, Inc. Bala Cynwyd, PA 19004, USA

Received 12 July 2007; received in revised form 14 September 2007; accepted 23 September 2007. published online 23 November 2007.

Abstract 

Background

The study was conducted to evaluate the effects of low-dose estrogen compared to placebo on ovarian activity during the traditional 7-day hormone-free interval (HFI) of an oral contraceptive (OC).

Study Design

Women were randomized to placebo or low-dose estrogen for 7 days during the HFI. Serum levels of estradiol, follicle-stimulating hormone (FSH), luteinizing hormone and inhibin B were obtained before, during and after treatment.

Results

Mean hormone levels remained constant or only increased slightly for the low-dose estrogen group compared to greater more sustained increases observed for the placebo group. Estradiol, FSH and inhibin B levels were substantially higher for those on placebo. Differences were most noticeable by the end of the HFI and persisted into the subsequent cycle.

Conclusion

Subjects receiving low-dose estrogen for 7 days during the HFI demonstrated more pronounced ovarian suppression compared to placebo as evidenced by attenuation of increases in serum inhibin B, FSH and estradiol levels.

Keywords: Ovarian suppression, Hormone-free interval, Inhibin B, Oral contraceptive, Low-dose estrogen

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PII: S0010-7824(07)00426-X

doi:10.1016/j.contraception.2007.09.010

Contraception
Volume 77, Issue 1 , Pages 34-39, January 2008