[Efficacy and safety of drospirenone-ethinylestradiol on contraception in healthy Chinese women: a multicenter randomized controlled trial].
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 microg ethinylestradiol plus 3 mg drospirenone, 573 cases) or desogestrel group (30 microg ethinylestradiol plus 150 microg 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 both 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.
Fan
Guang-sheng
GS
Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China. fgsxiehe@163.com
Bian
Mei-lu
ML
Cheng
Li-nan
LN
Cao
Xiao-ming
XM
Huang
Zi-rong
ZR
Han
Zi-yan
ZY
Jing
Xiao-ping
XP
Li
Jian
J
Wu
Shu-ying
SY
Xiong
Cheng-liang
CL
Xiong
Zheng-ai
ZA
Yue
Tian-fu
TF
D000328:Adult; D000736:Androstenes / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D001835:Body Weight / Q000187:drug effects; D002681:China; D003267:Contraception / Q000379:methods; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D017135:Desogestrel / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects; D017060:Patient Satisfaction; D011293:Premenstrual Syndrome / Q000188:drug therapy; D011795:Surveys and Questionnaires; D055815:Young Adult
D000736:Androstenes; D003277:Contraceptives, Oral, Combined; C534342:drospirenone and ethinyl estradiol combination; D004997:Ethinyl Estradiol; D017135:Desogestrel