| Efficacy, safety, and tolerability of a monophasic oral contraceptive containing nomegestrol acetate and 17β-estradiol: a randomized controlled trial. | |
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MedLine Citation:
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PMID: 22525910 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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OBJECTIVE: : To estimate the efficacy, cycle control, tolerability, and safety of a monophasic combined oral contraceptive containing nomegestrol acetate and 17β-estradiol (E2) in comparison with drospirenone and ethinyl E2. METHODS: : In a randomized, open-label, comparative multicenter trial, healthy women (n=2,281; age 18-50 years) at risk for pregnancy and in need of contraception were allocated in a 3:1 ratio to receive nomegestrol acetate (2.5 mg) and 17β-E2 (1.5 mg) in a 24-4-day regimen (investigational drug) or drospirenone (3.0 mg) and ethinyl E2 (30 micrograms) in a 21-7-day regimen (comparator) for 13 consecutive, 28-day cycles. The primary end point was the Pearl Index. RESULTS: : The Pearl Indices for 18- to 35-year-old women in the investigational (n=1,375) and comparator (n=463) groups were 1.27 (95% confidence interval [CI] 0.66-2.22) and 1.89 (95% CI 0.69-4.11), respectively. Respective 1-year cumulative pregnancy rates were 1.22 (95% CI 0.69-2.16) and 1.82 (95% CI 0.81-4.05). By the end of the trial, shorter, lighter scheduled bleeding or an absence of scheduled bleeding occurred with greater frequency (32.9%) in the investigational group, whereas unscheduled bleeding or spotting episodes were low (16.2% and 15.0% in the investigational and comparator groups, respectively). Acne prevalence decreased from approximately 33% at baseline to 22% and 14% at cycle 13 in the respective groups. In the investigational group, the most frequently reported adverse events were acne (16.4%), weight gain (9.5%), and irregular withdrawal bleeding (9.1%). CONCLUSION: : Nomegestrol acetate and 17β-E2 were well tolerated and provided excellent contraceptive efficacy and acceptable cycle control. CLINICAL TRIAL REGISTRATION: : Clinicaltrials.gov, www.clinicaltrials.gov, NCT00413062. LEVEL OF EVIDENCE: : I. |
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Authors:
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Carolyn Westhoff; Andrew M Kaunitz; Tjeerd Korver; Werner Sommer; Luis Bahamondes; Philip Darney; Carole Verhoeven |
Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Obstetrics and gynecology Volume: 119 ISSN: 1873-233X ISO Abbreviation: Obstet Gynecol Publication Date: 2012 May |
Date Detail:
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Created Date: 2012-04-24 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0401101 Medline TA: Obstet Gynecol Country: United States |
Other Details:
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Languages: eng Pagination: 989-99 Citation Subset: AIM; IM |
Affiliation:
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From Columbia University, New York, New York; the University of Florida College of Medicine, Jacksonville, Florida; Merck Sharpe & Dohme, Corp, Oss, the Netherlands; the University of Campinas, Campinas, Brazil; and the University of California, San Francisco, San Francisco, California. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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