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

ABSTRACT

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 17β-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 μg) 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.

KEYWORDS:

• Combined oral contraceptive
• Nomegestrol acetate
• 17β-oestradiol
• Efficacy
• Safety
• Cycle control

ACKNOWLEDGEMENTS

MSD provided financial support to the conduct of this study. Susan Abulhawa and Alex Loeb PhD, CMPP of Evidence Scientific Solutions, Philadelphia, PA, provided editorial and medical writing assistance but did not meet all ICMJE criteria for authorship.

Declaration of interest: The authors received no compensation or honoraria in association with this article and exercised sole and complete editorial responsibility for this manuscript. Werner Sommer, Carole Verhoeven and Tjeerd Korver are employees of MSD (Oss, the Netherlands). Merck provided the funding for this study. During the past five years, the other authors have had the following links with pharmaceutical firms manufacturing contraceptives: Diana Mansour has received financial support to attend pharmaceutical advisory board meetings, undertake research studies, speak at educational meetings and conferences along with travel grants from Merck, HRA Pharma, Consilient Healthcare and Bayer. Edith Weisberg has received research funding from Merck. Dr Taneepanichskul has received financial support from MSD to attend advisory board and research workshop meetings. Dr Gian Benedetto Melis has received financial support to attend pharmaceutical advisory board meetings, undertake research studies, speak at educational meetings and conferences along with travel grants from Organon Schering Plough, Pfizer Italia srl, Bayer S.p.A., Prodotti Formenti srl, and Theramez S.p.A. Dr Sundström-Poromaa has received financial support to attend pharmaceutical advisory board meetings and speak at educational meetings and conferences along with travel grants from Merck, Bayer and Lundbeck.