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Efficacy and tolerability of a monophasic combined oral contraceptive containing nomegestrol acetate and 17beta-oestradiol in a 24/4 regimen, in comparison to an oral contraceptive containing ethinylestradiol and drospirenone in a 21/7 regimen
Sexual Health Services, Newcastle Hospitals Community Health, Newcastle upon Tyne, UK.
Merck, Oss, Netherlands.
Merck, Oss, Netherlands.
Sydney Centre for Reproductive Health Research FPNSW, Sydney, Australia.
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2011 (English)In: European journal of contraception & reproductive health care, ISSN 1362-5187, E-ISSN 1473-0782, Vol. 16, no 6, 430-443 p.Article in journal (Refereed) Published
Abstract [en]

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?-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 ?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.

Place, publisher, year, edition, pages
2011. Vol. 16, no 6, 430-443 p.
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:uu:diva-163288DOI: 10.3109/13625187.2011.614029ISI: 000296739600004PubMedID: 21995590OAI: oai:DiVA.org:uu-163288DiVA: diva2:463530
Available from: 2011-12-09 Created: 2011-12-09 Last updated: 2017-12-08Bibliographically approved

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Sundström-Poromaa, Inger

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