Treatment of Uterine Myoma with 2.5 or 5 mg Mifepristone Daily during 3 Months with 9 Months Posttreatment Followup: Randomized Clinical Trial.

Objectives. To evaluate the efficacy, safety, and quality of life by using 2.5 and mifepristone 5 mg daily doses to treat uterine fibroids over 3 months with a 9-month followup period. Design. Randomized clinical trial. Place. "Eusebio Hernández" Hospital, Havana, Cuba. Subjects. 220 women with symptomatic uterine fibroids. Treatment. One-half (2.5 mg) or one-whole 5 mg mifepristone tablet. Variables to Evaluate Efficacy. Changes in fibroid and uterine volumes, in symptomatic prevalence and intensity, and in quality of life. Results. After 3-month treatment, fibroid volume decreased by 27.9% (CI 95% 20-35) and 45.5% (CI 95% 37-62), in the 2.5 and 5 mg groups, respectively, P = 0.003. There was no difference in the prevalence of symptoms at the end of treatment, unlike after 6- and 9-month followup when there was a difference. Amenorrhea was significantly higher in the 5 mg group, P = 0.001. There were no significant differences in mifepristone side effects between the groups. Both groups displayed a similar improvement in quality of life. Conclusions. The 2.5 mg dosage resulted in a lesser reduction in fibroid size but a similar improvement in quality of life when compared to the 5 mg dose. This trial is registered with ClinicalTrials.gov NCT01786226.

Mifepristone versus placebo to treat uterine myoma: a double-blind, randomized clinical trial.

OBJECTIVE: To evaluate the efficacy, safety, and quality of life of 5 mg mifepristone per day compared with a placebo in treating uterine fibroids. DESIGN: Randomized, double-blind clinical study. LOCATION: Eusebio Hernández Gynecology and Obstetrics Teaching Hospital, Havana, Cuba. SUBJECTS: One hundred twenty-four subjects with symptomatic uterine fibroids. TREATMENT: One daily capsule of 5 mg mifepristone or a mifepristone placebo over 3 months. VARIABLES IN EVALUATING SAFETY: Changes in fibroid and uterine volumes, changes in symptom prevalence and intensity, and changes in quality of life. RESULTS: Three months into treatment, fibroid volume was reduced by 28.5% in the mifepristone group with an increase of 1.8% in the placebo group (P = 0.031). There were significant differences between the groups with respect to pelvic pain prevalence (P = 0.006), pelvic pressure (P = 0.027), rectal pain (P = 0.013), hypermenorrhea (P < 0.001), and metrorrhagia (P = 0.002) at the end of treatment. Amenorrhea was 93.1% and 4.3% in the mifepristone and placebo groups, respectively (P < 0.001). Treatment side effects were significantly greater in the mifepristone group. Estradiol levels did not differ significantly between the placebo and mifepristone groups at the end of treatment. Improvement in quality of life was significantly greater in the categories of "symptoms" (P = 0.004) and "activity" (P = 0.045) in the mifepristone group. CONCLUSION: The 5 mg dosage of mifepristone presented significantly superior efficacy compared to the placebo.