Low-dose mifepristone versus placebo to treat uterine fibroids: A double-blind randomized clinical trial
Objective: To evaluate the efficacy and safety of 10 mg mifepristone administered daily compared with placebo in the treatment of subjects with uterine fibroids.Design: Randomized, double-blind, multicenter, placebo-controlled, parallel group clinical study.Treatment: 10 mg mifepristone or a mifepristone placebo administered daily over 3 months.Subjects: A total of 132 subjects with symptomatic uterine fibroids were enrolled and randomized into the study (66 subjects in each treatment group), with 112 subjects completed the treatment.Efficacy evaluation: Change in volume of the largest uterine fibroid was the primary efficacy variable, and secondary efficacy variables included changes in anemia and relevant symptoms, i.e.,percentage of subjects with amenorrhea, dysmenorrhea, pelvic pressure, non-menstrual abdominal pain, menstrual blood loss, and the improvement of hemoglobin, red blood cell count and hematocrit.Safety evaluation: Safety evaluation included the analyses of adverse events, laboratory values,and relevant endometrial changes.Results: Following 3-month treatment, the mean volume of the largest uterine fibroids decreased in both treatment groups.The estimated treatment difference between mifepristone and placebo was -33.64% (95%CI:-58.41%;-12.75%), which demonstrated 33.64% further reduction of the largest uterine fibroid volume was achieved with mifepristone treatment.Therefore, superiority of mifepristone is established over placebo when applying superiority margin of 10%.Mifepristone has also demonstrated a significant improvement over placebo of anemia and relevant clinical symptoms.Mifepristone is proved to be well tolerated in this study.The incidence rate of adverse event remained low in both treatment groups, and abdominal pain was the most commonly reported AE in mifepristone treatment group.Only 1 SAE (uterine fibroid degeneration) was reported during the study.Treatment ofmifepristone significantly decreased the estradiol level when compared to placebo.Conclusion: 10 mg mifepristone may offer an effective and safe treatment option for patients with uterine fibroids and 3-month treatment period is optimal.
mifepristone largest fibroid volume anemia amenorrhea
Chongdong Liu Shurong Zheng Zhiqiang Zhang Zhenyu Zhang
Department of Obstetrics and Gynecology, Chao-yang Hospital, Capital Medical University, Beijing, Ch Department of Obstetrics and Gynaecology, Peking University First Hospital, Beijing, China
国内会议
北京
英文
256-264
2016-04-09（万方平台首次上网日期，不代表论文的发表时间）