Efficacy and safety of an oral contraceptive containing ethinylestradiol 20 µg/drospirenone 3 mg (24/4 regimen) in three indications in the People’s Republic of China: a comparison with international studies

Figures & data

Table 1 Baseline characteristics of subjects enrolled in studies of ethinylestradiol 20 µg/drospirenone 3 mg administered in a 24/4 treatment regimen conducted in the People’s Republic of China, Europe, Latin America, and the USA

Indication	Contraception			Acne			PMDD
Study (country)	Caiyan et al^Citation18 (People’s Republic of China)a	Bachmann et al^Citation10 (Austria, Argentina, Brazil, Poland, USA)	Hernádi et al^Citation20 (Czech Republic, Italy, Hungary, Slovak Republic, Latvia, Belgium)	Zhang et al^Citation17 (People’s Republic of China)a	Koltun et al^Citation11 (USA)	Maloney et al^Citation12 (USA)	Fu et al^Citation19 (People’s Republic of China)a	Yonkers et al^Citation14 (USA)	Pearlstein et al^Citation13 (USA)
n	675	1,027	1,101	173	534	538	187	450	64
Age, years	32±5	24.7±4.4	24.7±4.7	23.7±5.6	25.3	25.1	29.0±7.0	31.5	31.8±5.5
BMI, kg/m^2	21.4±2.6	22.4±3.3	21.7±2.8	20.1±2.2	24.6	23.8	20.7±2.2	25.6	26.3±5.1
Ethnicity, n (%)
Caucasian	0	902 (87.8)	NR	0	360 (67.4)	369 (68.6)	0	345 (77.1)	48 (75.0)
Hispanic	0	47 (4.6)	NR	0	60 (11.2)	NR	0	43 (9.6)	5 (7.8)
Black	0	44 (4.3)	NR	0	81 (15.2)	NR	0	45 (10.0)	7 (10.9)
Asian	675 (100)	12 (1.2)	NR	(100)	13 (2.4)	NR	187 (100)	5 (1.1)	1 (1.6)
Other	0	22 (2.1)	NR	0	20 (3.7)	NR	0	10 (2.2)	3 (4.7)
Current smoker, n (%)	4 (0.6)	263 (25.6)	NR	5 (2.9)	92 (17.2)	60 (11.2)	2 (1.1)	NR	NR

Notes: All values are presented as mean ± standard deviation unless otherwise specified;

a includes some unpublished data.

Abbreviations: BMI, body mass index; NR, not reported; PMDD, premenstrual dysphoric disorder.

Figure 1 Comparison of unadjusted Pearl Index scores in women after treatment over 1 year with the ethinylestradiol 20 µg/drospirenone 3 mg combined oral contraceptive (YAZ^®) in three international studies conducted in the People’s Republic of China (Caiyan et al¹⁸), Europe, Latin America, and the USA (Bachmann et al¹⁰), and Europe (Hernádi et al²⁰).

Figure 2 Percentage change from baseline to endpoint (defined as cycle 6 with last observation carried forward for dropouts) in mean total acne lesion count in women with moderate acne treated with ethinylestradiol 20 µg/drospirenone 3 mg combined oral contraceptive (YAZ^®) or placebo in the studies conducted in the People’s Republic of China (Zhang et al¹⁷) and the USA (Koltun et al¹¹ and Maloney et al¹²). Values for the Koltun et al study are approximate as they were estimated from the graph presented in their publication. *P<0.001 versus placebo.

Figure 3 Change from baseline in DRSP scale scores after three cycles of treatment in women with premenstrual dysphoric disorder in ethinylestradiol 20 µg/drospirenone 3 mg combined oral contraceptive (YAZ^®) placebo-controlled studies conducted in the People’s Republic of China (Fu et al¹⁹) and the USA (Yonkers et al¹⁴ and Pearlstein et al¹³). *P<0.001 versus placebo.

Abbreviation: DRSP, Daily Record of Severity of Problems.

Table 2 Safety and tolerability of ethinylestradiol 20 µg/drospirenone 3 mg combined oral contraception administered in a 24/4 regimen (YAZ^®) in women from the People’s Republic of China, Europe, Latin America, and the USA. Adverse events shown are those reported by ≥2% of participants

Reference (study design, country)	Treatment (number of subjectsa)	Treatment cycles (n)	Proportion of subjects, n (%)
			Any AE	Any study drug-related AE	Any AE leading to discontinuation	Any SAE	Any study drug-related SAE	Most reported AEs (n [%])
Indication: oral contraception
Caiyan et al^Citation18 (SA, MC, OL; People’s Republic of China)	YAZb (675)	13	272 (40.3)	89 (13.2)	38 (5.6)	4 (0.6)	0	Nausea	23 (3.4)
Bachmann et al^Citation10 (SA, MC, OL; Austria, Argentina, Brazil, Poland, USA)	YAZb (1,027)	13	NR	395 (38.5)	77 (7.5)	NR	3 (0.3)	Headache Breast pain Nausea	67 (6.5) 65 (6.3) 26 (2.5)
Hernádi et al^Citation20 (SA, MC, OL; Czech Republic, Italy, Hungary, Slovak Republic, Latvia, Belgium)	YAZb (1,101)	13	526 (47.8)	233 (21.2)	69 (6.3)	22 (2.0)	0	Metrorrhagia Amenorrhea Headache	88 (8.0) 50 (4.5) 32 (2.9)
Indication: acne
Zhang et al^Citation17 (R, DB, MC, PC; People’s Republic of China)	YAZb (87) Placebo (86)	6	26 (29.9) 10 (11.6)	22 (25.3) 4 (4.7)	2 (2.3) 2 (2.3)	0 0	0 0	YAZ: Menorrhagia Metrorrhagia	7 (8.0) 7 (8.0)
								Placebo: Acne	3 (3.5)
Koltun et al^Citation11 (R, DB, MC, PC; USA)	YAZb (266) Placebo (268)	6	170 (63.9) 129 (48.1)	NR	17 (6.4) 13 (4.9)	1 (0.4) 1 (0.4)	0 0	YAZ: Upper respiratory infection Metrorrhagia Headache Nausea Sinusitis Pap smear suspicious Placebo: Headache Nausea Emotional lability Depression Metrorrhagia	35 (13.2) 28 (10.5) 23 (8.6) 17 (6.4) 15 (5.6) 15 (5.6) 10 (3.7) 7 (2.6) 6 (2.2) 5 (1.9) 3 (1.1)
Maloney et al^Citation12 (R, DB, MC, PC; USA)	YAZb (270) Placebo (268)	6	149 (55.2) 123 (45.9)	NR	16 (5.9) 9 (3.4)	1 (0.4) 5 (1.9)	0 0	YAZ: Upper respiratory infection Metrorrhagia Papanicolaou smear suspicious Headache	25 (9.3) 25 (9.3) 15 (5.6) 14 (5.2)
								Placebo: Upper respiratory infection Headache Flu syndrome Metrorrhagia Nausea	10 (3.7) 31 (11.6) 14 (5.2) 12 (4.5) 6 (2.2) 7 (2.6)
Indication: PMDD
Fu et al^Citation19 (R, DB, MC, PC; People’s Republic of China)	YAZb (93) Placebo (94)	3	41 (44.1) 29 (30.9)	35 (37.6) 20 (21.3)	5 (5.4) 1 (1.1)	0 0	0 0	YAZ: Metrorrhagia Menorrhagia Nausea Hypomenorrhea Headache Weight increased	12 (12.9) 8 (8.6) 5 (5.4) 4 (4.3) 3 (3.2) 3 (3.2)
								Placebo: Hypomenorrhea Nausea Metrorrhagia Dizziness	5 (5.3) 4 (4.3) 3 (3.2) 3 (3.2)
Yonkers et al^Citation14 (R, DB, MC, PC; USA)	YAZb (232) Placebo (218)	3	NR	118 (51.1) 66 (30.3)	35 (15.1) 9 (4.1)	NR	1 (0.4) 0	YAZ: Metrorrhagia Headache Nausea Breast pain Upper respiratory infection Asthenia Abdominal pain Sinusitis	58 (25.1) 45 (19.5) 43 (18.6) 31 (13.4) 23 (10.0) 19 (8.2) 12 (5.2) 9 (3.9)
								Placebo: Metrorrhagia Headache Nausea Breast pain Upper respiratory infection Asthenia Abdominal pain Sinusitis	10 (4.6) 44 (20.2) 11 (5.0) 11 (5.0) 24 (11.0) 8 (3.7) 6 (2.8) 11 (5.0)
Pearlstein et al^Citation13 (R, DB, MC, CO; USA)	YAZb (34) Placebo (30)	3	NR	26 (48.2) 14 (28.6)	4 (11.8) 3 (10.0)	NR	NR	YAZ: Nausea Upper respiratory infection Headache Intermenstrual bleeding Breast pain Nervousness Asthenia	10 (18.5) 9 (16.7) 8 (14.8) 8 (14.8) 6 (11.1) 5 (9.3) 4 (7.4)
								Placebo: Nausea Upper respiratory infection Headache Asthenia Tooth disorder Accidental injury	5 (10.2) 3 (6.1) 7 (14.3) 4 (8.2) 4 (8.2) 4 (8.2)

Notes:

a Number of subjects in the full analysis set of each study;

b oral contraceptive containing 20 µg ethinylestradiol and 3 mg drospirenone administered once daily for 24 consecutive days followed by a 4-day hormone-free interval.

Abbreviations: AE, adverse event; CO, crossover; DB, double-blind; MC, multicenter; NR, not reported; OL, open-label; PC, placebo-controlled; PMDD, premenstrual dysphoric disorder; R, randomized; SA, single-arm; SAE, serious adverse event.

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