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《Chinese Journal of Family Planning》 2008-06
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An Open-label,Randomized,Comparative,Multi-center Trial on Contraception Efficacy,Safety and Acceptability of Mercilon~

Yu Xiaolan,Zheng Shurong,Chen Shuling,et al.Gynecology Department,First Hospital of Beijing University,Beijing 100034  
Objective:To assess the contraception efficacy,safety and acceptability of Mercilon~ compared to Minulet~ in women in China by randomized comparative clinical trial.To compare cycle control and tolerability of two oral contraceptives in healthy women in China.Methods:This was an open-label,randomized,group-comparative,multicenter trial.238 healthy women aged 18-40 years were randomized to Mercilon~ group(120cases)and Minulet~ group(118cases)who accepted six cycles of treatment,and each cycle was 28 days.Follow-up survey was performed at 5-6weeks,13-14weeks and 25-26 weeks.Diary cards were used to monitor compliance,bleeding pattern and subjective side effects.Results:No pregnancies were observed during the study.The discontinuation rate were 10% in Mercilon~ group and 11.02% in Minulet~ group due to subjective side effects(4.17% vs 9.3%,respectively),which showed significantly different(P0.01).There were no serious adverse events and no significant weight changes were observed in either group.The amount and days of menses were decreased.The side effects of two groups showed no significant difference,which were 41.6% and 44.1% in Mercilon group and Minulet~ group,respectively.In Mercilon~ group,the main side effect was bleeding/spotting which accounted for 24.2%.In Minulet~ group,the main side effect was nausea(22.03%)and headache/dizziness(23.72%).The side effects were occurred at the first week of treatment and decreased afterword.Conclusion:Mercilon~ is an oral contraceptive that reliable and well tolerated in Chinese women.
【CateGory Index】: R169.4
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