Abstract
Background
This clinical trial was conducted to demonstrate the efficacy and safety of a 91-day
extended-regimen, low-dose combination oral contraceptive (OC) consisting of 84 days
of ethinyl estradiol (EE) 20 mcg/levonorgestrel (LNG) 100 mcg, followed by 7 days
of 10 mcg EE in place of placebo.
Study Design
A multicenter open-label, single-treatment, Phase 3 study evaluated women aged 18
through 40 years over a treatment period of up to 1 year (four 91-day extended cycles).
All subjects completed daily paper diaries to monitor compliance, bleeding and additional
forms of contraception used during the course of the study.
Results
A total of 1249 subjects completed the study. The Pearl Index was 2.74 (95% confidence
interval, 1.92���3.78), based on 36 pregnancies that occurred after the onset of treatment
and within 14 days after the last combination tablet in women aged 18���35 years.
Among compliant-use subjects 18���35 years old, the Pearl Index was 1.73 based on
22 on-treatment pregnancies. The life table pregnancy rate for subjects 18���35 years
of age was 2.39%. Cycle control and adverse events reported with this regimen were
similar to those reported with other low-dose OCs.
Conclusions
This study demonstrated effective prevention of pregnancy with a 20-mcg EE, 91-day
extended-regimen OC. In addition, the regimen was well tolerated and incidence of
adverse events were consistent with what has been reported with other low-dose OCs.
Keywords
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Article info
Publication history
Published online: September 04, 2009
Accepted:
July 9,
2009
Received in revised form:
July 7,
2009
Received:
March 20,
2009
Footnotes
���This study was funded by Duramed Pharmaceuticals, Inc. Drs. Reape and Margolis are full-time employees of Duramed Research, Inc.
Identification
Copyright
© 2010 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
