Adding low-dose estrogen to the hormone-free interval: impact on bleeding patterns in users of a 91-day extended regimen oral contraceptive.

Abstract

BACKGROUND:

A cross-study analysis of contraceptive clinical trials for two different 91-day oral contraceptive (OC) regimens was performed to examine the impact on bleeding patterns when supplementing the 7-day hormone-free interval with 10 mcg ethinyl estradiol (EE) daily.

STUDY DESIGN:

Two separate 1-year Phase 3 clinical programs were conducted using similar study designs. The percentages of subjects reporting bleeding and spotting using electronic diaries for each 91-day cycle were compared.

RESULTS:

Scheduled bleeding with the EE regimen was less than that reported with the regimen utilizing placebo during Days 85-91, with significant differences noted for all four 91-day cycles. Unscheduled bleeding decreased more quickly with the 91-day regimen containing low-dose EE in place of placebo, with significant differences noted during the third cycle.

CONCLUSIONS:

This cross-study comparison suggests that the administration of low-dose estrogen in place of placebo in a 91-day extended regimen OC improves the bleeding profile.

• Authors: Andrew M Kaunitz, David J Portman, Howard Hait, Kathleen Z Reape
• Journal: Contraception (Contraception) Vol. 79 Issue 5 Pg. 350-5 (May 2009) ISSN: 1879-0518 [Electronic] United States
• PMID: 19341846 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Contraceptives, Oral, Hormonal
• Estrogens
• Seasonale
• Ethinyl Estradiol
• Levonorgestrel
• Ethinyl Estradiol-Norgestrel Combination

Topics

• Adult
• Clinical Trials as Topic
• Contraceptives, Oral, Hormonal (administration & dosage)
• Estrogens (administration & dosage, adverse effects)
• Ethinyl Estradiol (administration & dosage, adverse effects)
• Ethinyl Estradiol-Norgestrel Combination (administration & dosage, adverse effects)
• Female
• Humans
• Levonorgestrel (administration & dosage, adverse effects)
• Menstruation (drug effects)
• Metrorrhagia (chemically induced)
• Retrospective Studies
• Young Adult