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

Diana Mansour, Carole Verhoeven, Werner Sommer, Edith Weisberg, Surasak Taneepanichskul, Gian Benedetto Melis, Inger Sundström-Poromaa, Tjeerd Korver, Diana Mansour, Carole Verhoeven, Werner Sommer, Edith Weisberg, Surasak Taneepanichskul, Gian Benedetto Melis, Inger Sundström-Poromaa, Tjeerd Korver

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.

Figures

Figure 1
Figure 1
Patient flow through the trial. NO MAC, nomegestrol acetate; E2, oestradiol; EE, ethinylestradiol; DRSP, drospirenone; AE, adverse event.
Figure 2
Figure 2
Mean number of bleeding-spotting days per 91-day reference periods for (A) NOMAC/E2 and (B) DRSP/EE. NOMAC, nomegestrol acetate; E2, oestradiol; EE, ethinylestradiol; DRSP drospirenone.
Figure 3
Figure 3
(A) Incidences (%) and (B) duration (median number of days) of breakthrough bleeding-spotting for N0MAC/E2 (grey bars) and DRSP/EE (black bars). The incidences were compared statistically between the treatment groups. *p < 0.05 vs. DRSP/EE. NOMAC, nomegestrol acetate; E2, oestradiol; EE, ethinylestradiol; DRSP drospirenone.
Figure 4
Figure 4
(A) Incidences of absence of withdrawal bleeding (%) and (B) duration of withdrawal bleeding (median number of days) for NOMAC/E2 (grey bars) and DRSP/EE (black bars). The incidences were compared statistically between the treatment groups. *p < 0.05 vs. DRSP/EE. NOMAC, nomegestrol acetate; E2, oestradiol; EE, ethinylestradiol; DRSP drospirenone.
Figure 5
Figure 5
(A) Prevalence (%) of acne and (B) changes in acne severity (%) from baseline to last measurement during treatment with NOMAC/E2 (grey bars) and DRSP/EE (black bars). NOMAC, nomegestrol acetate; E2, oestradiol; EE, ethinylestradiol; DRSP drospirenone; LM, last measurement.

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