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Contraceptive efficacy of a combined oral contraceptive containing ethinyloestradiol 20μg/drospirenone 3mg administered in a 24/4 regimen: a pooled analysis of four open-label studies.
MedLine Citation:
PMID:  21277674     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
OBJECTIVE: To determine the contraceptive efficacy of a low-dose combined oral contraceptive containing ethinyloestradiol (EE) 20μg/drospirenone (drsp) 3mg administered for 24 days followed by a four-day hormone-free interval (24/4 regimen), by pooling data from four clinical trials. STUDY DESIGN: Data on the occurrence of pregnancy during treatment in four open-label trials that enrolled healthy female volunteers aged 17-36 years, who received EE 20μg/drsp 3mg in a 24/4 regimen for 7 or 13 cycles, were pooled. RESULTS: Sixteen pregnancies occurred among 2386 women during 729,537 days (26,055 cycles) of treatment exposure, resulting in a Pearl Index (PI) of 0.80 (upper two-sided 95% confidence interval (CI) limit of 1.30). Of these pregnancies, seven were defined as method failures, resulting in an adjusted PI of 0.41 (upper two-sided 95% CI limit of 0.85), based on 616,607 days (22,022 cycles) of treatment. The Kaplan-Meier estimate for the one-year cumulative probability of contraceptive protection was 99.21%. CONCLUSIONS: The EE 20μg/drsp 3mg combined oral contraceptive administered in a 24/4 regimen has acceptable contraceptive efficacy.
Authors:
Leena Anttila; Gloria Bachmann; László Hernádi; Michael Kunz; Joachim Marr; Christine Klipping
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-1-28
Journal Detail:
Title:  European journal of obstetrics, gynecology, and reproductive biology     Volume:  -     ISSN:  1872-7654     ISO Abbreviation:  -     Publication Date:  2011 Jan 
Date Detail:
Created Date:  2011-1-31     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0375672     Medline TA:  Eur J Obstet Gynecol Reprod Biol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2011. Published by Elsevier Ireland Ltd.
Affiliation:
The Family Federation of Finland, Turku Clinic, Turku, Finland.
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