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

While combined oral contraceptives are a popular choice in developed Western countries they are used by only 1% of women who are married or in a relationship in the Peoples Republic of China. The purpose of this review is to describe the efficacy and safety of the combined oral contraceptive containing ethinylestradiol (EE) 20 microg/drospirenone 3 mg taken in a 24/4 regimen (YAZ®; Bayer HealthCare Pharmaceuticals Berlin Germany) by Chinese women and to compare these results with those in women assessed in the international studies. Studies of EE 20 microg/drospirenone 3 mg in three different indications (contraception acne and premenstrual dysphoric disorder [PMDD]) have been conducted in Chinese women. The results of these three studies indicate that the EE 20 microg/drospirenone 3 mg combined oral contraceptive is a good long-term contraceptive option in Chinese women providing 99% contraceptive protection over the observed 1-year treatment period and additionally had a favorable effect on moderate acne vulgaris and relieved the symptoms of PMDD. The contraceptive efficacy improvement in acne and relief from PMDD symptoms observed in these studies did not differ from the effects observed in other international studies of EE 20 microg/drospirenone 3 mg indicating that EE 20 microg/drospirenone 3 mg is as effective in Chinese women as in other ethnicities. Further EE 20 microg/drospirenone 3 mg demonstrated a similar safety and tolerability profile in women enrolled in the Chinese and international trials with no unexpected adverse events reported in any of the three Chinese trials. Overall the efficacy tolerability and degree of non-contraceptive benefits with EE 20 microg/drospirenone 3 mg appear similar in Chinese women when compared with those reported in larger studies done at other international centers.