Efficacy and safety of an ascending-dose, extended-regimen levonorgestrel/ethinyl estradiol combined oral contraceptive.

Abstract

OBJECTIVE:

To evaluate the efficacy and safety of an ascending-dose, extended-regimen (ADER) combined oral contraceptive consisting of levonorgestrel (LNG) 150 mcg/ethinyl estradiol (EE) 20 mcg for 42 days, LNG 150 mcg/EE 25 mcg for 21 days, LNG 150 mcg/EE 30 mcg for 21 days and EE 10 mcg for 7 days.

STUDY DESIGN:

This was a multicenter, open-label, phase 3, single-arm study. Sexually active women aged 18-40 years were enrolled and received ADER for up to 1 year (4 consecutive 91-day cycles). Participants kept diaries to record adherence, bleeding/spotting and other contraceptive use. Efficacy was measured using the Pearl Index and the life-table method; safety and tolerability were assessed through reported adverse events (AEs).

RESULTS:

A total of 3701 women were enrolled and 2144 completed the study. The Pearl Index was 3.19 [95% confidence interval (CI), 2.49-4.03], based on 70 pregnancies that occurred after ADER initiation and ≤ 7 days after the last LNG/EE or EE-only pill in women aged 18-35 years, excluding cycles in which another contraceptive method was used. Life-table pregnancy rate was 2.82% (95% CI, 2.23%-3.57%) for all users aged 18-35 years. Unscheduled bleeding/spotting decreased with increasing EE doses within each cycle and decreased after cycle 1. No unexpected AEs or changes in laboratory parameters were reported.

CONCLUSION:

This study demonstrated that ADER effectively prevented pregnancy with a favorable safety and tolerability profile.

• Authors: David J Portman, Andrew M Kaunitz, Brandon Howard, Herman Weiss, Jennifer Hsieh, Nancy Ricciotti
• Journal: Contraception (Contraception) Vol. 89 Issue 4 Pg. 299-306 (Apr 2014) ISSN: 1879-0518 [Electronic] United States
• PMID: 24576794 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

Chemical References

• Contraceptives, Oral, Combined
• Estrogens
• Ethinyl Estradiol
• Levonorgestrel

Topics

• Adult
• Contraceptives, Oral, Combined (adverse effects)
• Estrogens (administration & dosage, adverse effects)
• Ethinyl Estradiol (administration & dosage, adverse effects)
• Female
• Humans
• Levonorgestrel (administration & dosage, adverse effects)
• Menstrual Cycle (drug effects)
• Pregnancy
• Treatment Outcome
• Young Adult