| The efficacy and safety of a low-dose, 91-day, extended-regimen oral contraceptive with continuous ethinyl estradiol. | |
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MedLine Citation:
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PMID: 20004272 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Robin Kroll; Kathleen Z Reape; Marya Margolis |
Publication Detail:
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Type: Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Contraception Volume: 81 ISSN: 1879-0518 ISO Abbreviation: Contraception Publication Date: 2010 Jan |
Date Detail:
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Created Date: 2009-12-16 Completed Date: 2010-02-22 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0234361 Medline TA: Contraception Country: United States |
Other Details:
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Languages: eng Pagination: 41-8 Citation Subset: IM |
Affiliation:
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Women's Clinical Research Center, Seattle, WA 98105, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Contraceptives, Oral, Combined / administration & dosage, adverse effects Drug Administration Schedule Ethinyl Estradiol / administration & dosage*, adverse effects* Female Humans Levonorgestrel / administration & dosage, adverse effects Pregnancy Pregnancy Rate |
| Chemical | |
Reg. No./Substance:
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0/Contraceptives, Oral, Combined; 57-63-6/Ethinyl Estradiol; 797-63-7/Levonorgestrel |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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