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Nomegestrol acetate/estradiol: a guide to its use in oral contraception

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Abstract

Nomegestrol acetate/estradiol (Zoely™) is the first monophasic combined oral contraceptive to contain estradiol. It is taken in 28-day cycles, consisting of 24 active therapy days with 4 placebo days (i.e. 24/4-day cycles). As contraceptive therapy in two 1-year, phase III trials in healthy women, nomegestrol acetate/estradiol was at least as effective (in terms of the Pearl Index) as drospirenone/ethinylestradiol. Its tolerability profile was consistent with that expected for a combined oral contraceptive, and was comparable to that of drospirenone/ethinylestradiol.

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References

  1. Burkman R, Bell C, Serfaty D. The evolution of combined oral contraception: improving the risk-to-benefit ratio. Contraception. 2011;84(1):19–34.

    Article  PubMed  CAS  Google Scholar 

  2. Bitzer J, Simon JA. Current issues and available options in combined hormonal contraception. Contraception. 2011;84(4):342–56.

    Article  PubMed  CAS  Google Scholar 

  3. Lello S. Nomegestrol acetate: pharmacology, safety profile and therapeutic efficacy. Drugs. 2010;70(5):541–59.

    Article  PubMed  CAS  Google Scholar 

  4. Kuhl H. Pharmacology of estrogens and progestogens: influence of different routes of administration. Climacteric. 2005;8(Suppl 1):3–63.

    Article  PubMed  CAS  Google Scholar 

  5. Sitruk-Ware R, Nath A. Metabolic effects of contraceptive steroids. Rev Endocr Metab Disord. 2011;12(2):63–75.

    Article  PubMed  CAS  Google Scholar 

  6. Sandset PM, Høibraaten E, Eilertsen AL, et al. Mechanisms of thrombosis related to hormone therapy. Thromb Res. 2009;123(Suppl 2):S70–3.

    Article  PubMed  Google Scholar 

  7. Fruzzetti F, Bitzer J. Review of clinical experience with estradiol in combined oral contraceptives. Contraception. 2010;81(1):8–15.

    Article  PubMed  CAS  Google Scholar 

  8. Zoely 2.5 mg/1.5 mg film-coated tablets: summary of product characteristics; London: European Medicines Agency; 2012.

  9. Chabbert-Buffet N, Chassard D, Ochsenbein E, et al. Inhibition of ovulation by NOMAC/E2, a novel monophasic oral contraceptive combining nomegestrol acetate and 17β-oestradiol: a double-blind, randomised, dose-finding pilot study. Eur J Contracept Reprod Health Care. 2011;16(2):76–84.

    Article  PubMed  CAS  Google Scholar 

  10. Christin-Maitre S, Serfaty D, Chabbert-Buffet N, et al. Comparison of a 24-day and a 21-day pill regimen for the novel combined oral contraceptive, nomegestrol acetate and 17β-estradiol (NOMAC/E 2): a double-blind, randomized study. Hum Reprod. 2011;26(6):1338–47.

    Article  PubMed  CAS  Google Scholar 

  11. Mansour D, Verhoeven C, Sommer W, et al. Efficacy and tolerability of a monophasic combined oral contraceptive containing nomegestrol acetate and 17β-oestradiol in a 24/4 regimen, in comparison to an oral contraceptive containing ethinylestradiol and drospirenone in a 21/7 regimen. Eur J Contracept Reprod Health Care. 2011;16(6):430–43.

    Article  PubMed  CAS  Google Scholar 

  12. Westhoff C, Kaunitz AM, Korver T, et al. Efficacy, safety, and tolerability of a monophasic oral contraceptive containing nomegestrol acetate and 17ß-estradiol: a randomized controlled trial. Obstet Gynecol. 2012;119(5):989–99.

    Article  PubMed  CAS  Google Scholar 

  13. Zoely (nomegestrol/estradiol): European public assessment report. London: European Medicines Agency; 2011.

  14. Fenton C, Wellington K, Moen MD, et al. Drospirenone/ethinylestradiol 3 mg/20 μg (24/4 day regimen): a review of its use in contraception, premenstrual dysphoric disorder and moderate acne vulgaris. Drugs. 2007;67(12):1749–65.

    Article  PubMed  CAS  Google Scholar 

  15. Duijkers IJM, Klipping C, Grob P, et al. Effects of a monophasic combined oral contraceptive containing nomegestrol acetate and 17 beta-oestradiol on ovarian function in comparison to a monophasic combined oral contraceptive containing drospirenone and ethinylestradiol. Eur J Contracept Reprod Health Care. 2010;15(5):314–25.

    Article  PubMed  CAS  Google Scholar 

  16. Ågren UM, Anttila M, Mäenpää-Liukko K, et al. Effects of a monophasic combined oral contraceptive containing nomegestrol acetate and 17β-oestradiol compared with one containing levonorgestrel and ethinylestradiol on haemostasis, lipids and carbohydrate metabolism. Eur J Contracept Reprod Health Care. 2011;16(6):444–57.

    Article  PubMed  Google Scholar 

  17. Sørdal T, Grob P, Verhoeven C. Effects on bone mineral density of a monophasic combined oral contraceptive containing nomegestrol acetate/17ß-estradiol in comparison to levonorgestrel/ethinylestradiol. Acta Obstet Gynecol Scand. 2012;91(11):1279–85.

    Article  PubMed  Google Scholar 

  18. Yang LPH, Plosker GL. Nomegestrol acetate/estradiol in oral contraception. Drugs. 2012;71(14):1917–28.

    Article  Google Scholar 

Download references

Acknowledgment

This article was reviewed by L. Bahamondes, Department of Obstetrics and Gynaecology, University of Campinas, Campinas, Brazil.

Disclosure

This article was adapted from Drugs 2012;71(14):1917–28 [18]. The preparation of these reviews was not supported by any external funding. During the review process, the manufacturer of the agent under review was offered an opportunity to comment on the articles. Changes resulting from comments received were made by the authors on the basis of scientific and editorial merit.

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Correspondence to Katherine A. Lyseng-Williamson.

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Lyseng-Williamson, K.A., Yang, L.P.H. & Plosker, G.L. Nomegestrol acetate/estradiol: a guide to its use in oral contraception. Drugs Ther Perspect 29, 1–6 (2013). https://doi.org/10.1007/s40267-012-0005-9

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  • DOI: https://doi.org/10.1007/s40267-012-0005-9

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