Efficacy and safety of drospirenone-ethinylestradiol on contraception in healthy Chinese women: a multicenter randomized controlled trial / 中华妇产科杂志

ABSTRACT

Objective To evaluate the contraception efficacy, mode of bleeding, side effects and other positive effects of drospirenone-ethinylestradiol (Yasmin) in healthy Chinese women. Methods This was a multicenter, randomized, control study of 768 healthy Chinese women who consulted about contraception. The subjects were randomized into Yasmin group (30 μg ethinylestradiol plus 3 mg drospirenone, 573 cases) or desogestrel group (30 μg ethinylestradiol plus 150 μg desogestrel, 195 cases) with the ratio of 3 1. Each individual was treated for 13 cycles. Further visits were required at cycle 4, cycle 7, cycle 10 and cycle 13 of treatment. Weight, height, body mass index were evaluated at each visit. The menstrual distress questionnaire (MDQ) was given to the women at baseline, visit 3 (cycle 7) and visit 5 (after cycle 13). Results The values of basal features were similar between two groups (P> 0.05). The Pearl index (method failure) of Yasmin was 0. 208/hundred women year which was lower than that of desogestrel (0. 601/hundred women year). The mode of bleeding was similar between two groups after trial without showing any significant difference. According to MDQ subscale, the improvement of water retention and increasing appetite during inter-menstrual period and water retention and general well-being during menstrual period in the Yasmin group ( -0. 297, -0. 057, 0. 033, 0. 150 respectively) was more obvious than that in the desogestrel group ( - 0. 108, 0. 023, 0. 231, - 0. 023 respectively) with a significant difference (P < 0. 05 ). Some other values which improved in beth two groups, especially the improvement of breast tenderness and pain and skin abnormality in Yasmin group (18.0%, 89/494; 12. 6%, 62/494) was more distinct than that in desogestrel group (11.3%, 19/168; 5.4%, 9/168). The mean weight increased in desogestrel group (0. 57 kg) while it decreased in Yasmin group ( -0. 28 kg) with a significant difference (P < 0. 01 ). Conclusions Both Yasmin and desogestrel have good efficacy on contraception and similar modes of menstrual bleeding. Yasmin is better than desogestrel in terms of weight control and premenstrual syndrome of oral contraceptive.