Effects of a monophasic combined oral contraceptive containing nomegestrol acetate and 17β-oestradiol on ovarian function in comparison to a monophasic combined oral contraceptive containing drospirenone and ethinylestradiol

Abstract

Objective To compare the effects on ovarian activity of two oral contraceptives containing nomegestrol acetate (NOMAC)/17β-oestradiol (E2) or drospirenone (DRSP)/ethinylestradiol (EE).

Methods In this open-label, randomised, six-cycle study, 32 subjects using NOMAC/E2 (2.5–1.5 mg; 24/4-day regimen) were compared to 16 subjects using DRSP/EE (3 mg–30 μg; 21/7-day regimen). Measurements included serum oestradiol, progesterone, follicle stimulating hormone (FSH) and luteinising hormone (LH), and ultrasonography of follicular diameter.

Results No ovulations occurred during treatment. Progesterone was fully suppressed, with mean maximum values <2 nmol/l in both groups over all cycles. For NOMAC/E2, mean maximum follicular diameter decreased from 19.3 mm before treatment to between 6.9 and 8.2 mm during treatment, with no subject having a follicular diameter ≥15 mm. For DRSP/EE, a decrease from 19.6 to between 7.4 and 10.8 mm was observed, with two subjects (12.5%) having a maximum follicle diameter ≥15 mm. These findings were consistent with observed FSH reductions; full suppression of LH surges was observed in both groups. Post-treatment return of ovulation in both groups occurred on average 21 days after the last active tablet intake.

Conclusions NOMAC/E2 achieves consistent ovulation inhibition, with suppressive effects on the ovaries at least similar to those of DRSP/EE.

KEYWORDS:

• Oral contraceptive
• Nomegestrol acetate
• 17β-oestradiol
• Ovulation inhibition
• Contraceptive efficacy

Acknowledgement

Editorial assistance was provided by Donna McGuire of Evidence Scientific Solutions, Philadelphia, PA, USA. This assistance was funded by Schering Corp., a division of Merck & Co.

Declaration of interest: Paul Grob and Tjeerd Korver are employees of MSD, sponsor of this clinical trial. Ingrid Duijkers and Christine Klipping are directors of Dinox BV, the contract research organisation that conducted the clinical trial.