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Lookup NU author(s): Dr Diana Mansour
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Objectives The primary objective was to assess the efficacy, cycle control and tolerability of a monophasic combined oral contraceptive (COC) containing nomegestrol acetate (NOMAC) and 17 beta-oestradiol (E2). Effects on acne were evaluated as a secondary objective. Results were compared to those of a COC containing drospirenone (DRSP) and ethinylestradiol (EE). Methods Women (aged 18-50 years) were randomised to receive NOMAC/E2 (2.5 mg/1.5 mg) in a 24/4-day regimen (n = 1591) or DRSP/EE (3 mg/30 mu g) in a 21/7-day regimen (n = 535) for 13 cycles. Results Estimated Pearl Indices for NOMAC/E2 and DRSP/EE were 0.38 and 0.81 in women aged <= 35 years and 0.31 and 0.66 for all women (18-50 years), respectively. Scheduled withdrawal bleedings were shorter and lighter among users of NOMAC/E2 and were sometimes absent altogether. Intracyclic bleeding/spotting was infrequent in both groups, and decreased over time. Type and frequency of adverse events were similar to those typically reported for COCs. Conclusions These data show that NOMAC/E2 provides high contraceptive efficacy with acceptable cycle control as well as an overall adverse event profile similar to that of DRSP/EE.
Author(s): Mansour D, Verhoeven C, Sommer W, Weisberg E, Taneepanichskul S, Melis GB, Sundstrom-Poromaa I, Korver T
Publication type: Article
Publication status: Published
Journal: The European Journal of Contraception and Reproductive Health Care
Year: 2011
Volume: 16
Issue: 6
Pages: 430-443
Print publication date: 01/12/2011
ISSN (print): 1362-5187
ISSN (electronic): 1473-0782
Publisher: Informa Healthcare
URL: http://dx.doi.org/10.3109/13625187.2011.614029
DOI: 10.3109/13625187.2011.614029
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