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.

OBJECTIVE

To compare the effects on ovarian activity of two oral contraceptives containing nomegestrol acetate (NOMAC)/17 beta-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 microg; 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.