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

Figures & data

Figure 1. Patient flow through the trial. NOMAC, nomegestrol acetate; E2, oestradiol; EE, ethinylestradiol; DRSP, drospirenone; AE, adverse event.

Table 1 Demographic characteristics of subjects at screening

	NOMAC/E2	DRSP/EE	Total
N	1591	535	2126
Age
Mean years (SD)	28 (7)	28 (7)	28 (7)
18–35 years n (%)	1319 (82.9%)	443 (82.8%)	1762 (82.9%)
36–50 years n (%)	272 (17.1%)	92 (17.2%)	364 (17.1%)
Race n (%)
Asian	77 (4.8%)	26 (4.9%)	103 (4.8%)
Black/African American	4 (0.3%)	3 (0.6%)	7 (0.3%)
White/Caucasian	1501 (94.3%)	501 (93.6%)	2002 (94.2%)
Other	9 (0.6%)	5 (0.9%)	14 (0.7%)
Ethnicity n (%)^14
Missing	1	0	1
Hispanic or Latino	15 (0.9%)	8 (1.5%)	23 (1.1%)
Not Hispanic or Latino	1575 (99.1%)	527 (98.5%)	2102 (98.9%)
Body weight, mean kg (SD)	63.4 (10.5)	63.7 (10.1)	63.5 (10.4)
BMI, mean kg/m^2 (SD)	23.0 (3.5)	23.0 (3.4)	23.0 (3.5)
Smoking n (%)	381 (24.0%)	146 (27.3%)	527 (24.8%)
Contraceptive method at screening n (%)
None	155 (9.7%)	58 (10.8%)	213 (10.0%)
COC
All	1072 (67.4%)	356 (66.5%)	1428 (67.2%)
DRSP/EE only	281 (17.7%)	73 (13.6%)	354 (16.7%)
Foam, condom, suppositories, diaphragm	255 (16.0%)	83 (15.5%)	338 (15.9%)
POP	34 (2.1%)	16 (3.0%)	50 (2.4%)
Hormonal IUD	10 (0.6%)	5 (0.9%)	15 (0.7%)
Non-hormonal IUD	14 (0.9%)	6 (1.1%)	20 (0.9%)
NuvaRing^®	28 (1.8%)	5 (0.9%)	33 (1.6%)
Patch	6 (0.4%)	4 (0.7%)	10 (0.5%)

NOMAC/E2, nomegestrol acetate/17β-oestradiol (NOMAC/E2); DRSP/EE, drospirenone/ethinylestradiol (DRSP/EE); BMI, body mass index; COC, combined oral contraceptive; POP, progestogen-only pill; IUD, intrauterine device; POP, progestogen-only pill; SD, standard deviation.

Table 2 Summary of contraceptive efficacy (Pearl Index and life-table analysis) for nomegestrol acetate/17β-oestradiol (NOMAC/E2) and drospirenone/ethinylestradiol (DRSP/EE) in the overall population and age subgroups

	NOMAC/E2		DRSP/EE
	18–50 years	≤ 35 years	18–50 years	≤ 35 years
N	1587	1315	534	442
Pearl Index analysis
Exposure (woman-years)	1292.5	1057.6	452.8	372.4
Pregnancies*	4	4	3	3
Pearl Index estimate	0.31	0.38	0.66	0.81
95% CI	0.08, 0.79	0.10, 0.97	0.14, 1.94	0.17, 2.35
Life-table analysis
Cumulative pregnancy rate after 1 year (%)	0.33	0.40	0.64	0.77
95% CI	0.12, 0.87	0.15, 1.06	0.21, 1.97	0.25, 2.39

CI, confidence interval.

*Pregnancies with conception date from the day of first intake of trial medication up to and including the days of last intake of trial medication extended with a maximum of two days. This Pearl Index was calculated by excluding cycles with condom use from the analysis.

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. (A) Incidences (%) and (B) duration (median number of days) of breakthrough bleeding-spotting 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 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. (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.