I.

ObjectivesTo evaluate the efficacy and safety of 2.5 mg and 5 mg mifepristone during 3 months for the treatment of uterine fibroids before surgery.DesignMulticenter randomized clinical trial.LocationsEusebio Hernández Hospital, Havana, Cuba and the Alemán Hospital, Managua, Nicaragua.SubjectsIncluded in the study were 146 women with symptomatic uterine fibroids.TreatmentGroup I: half a tablet of 5 mg (2.5 mg) mifepristone taken orally every 24 hours, and Group II: one tablet of 5 mg mifepristone taken orally every 24 hours over a period of 3 months in both groups. Two endometrial biopsies were performed.Variables to evaluate efficacyIncrease in average hemoglobin, changes in fibroid and uterine volume, and symptomatic improvement.ResultsThe average hemoglobin at the end of treatment was 0.6 g/dL greater in the 5 mg mifepristone group (P = 0.033). In both groups there were similar reductions in fibroid volumes. Clinical improvement was more significant in the 5 mg group.ConclusionThe dose to be used should be 5 mg.

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ObjectivesThe aim of this study was to evaluate the safety and improvement in quality of life using 10 mg and 5 mg daily doses of mifepristone for the treatment of uterine fibroids.DesignThe research was a randomized double-blind clinical study undertaken at the Eusebio Hernández Hospital in Havana, Cuba.Subjects and methodsSeventy subjects with symptomatic uterine fibroids took one daily capsule of 10 mg or 5 mg mifepristone orally for 9 months. One to three endometrial biopsies were performed. In evaluating safety, the variables studied were endometrial changes associated with mifepristone, elevation of hepatic transaminases, side effects of mifepristone, and instances and duration of irregular bleeding.ResultsThere were 30/49 (61.2%) and 13/24 (54.2%) diagnoses of endometrial changes associated with mifepristone in the 10 mg and 5 mg groups, respectively (P = 0.282). At every evaluation visit the average endometrial thickness was significantly greater in the 10 mg group than in the 5 mg group (P = 0.013, P = 0.002, and P = 0.013, respectively). Only five subjects had slight elevations in their hepatic transaminases after 9 months’ treatment. Sixteen of 35 (45.7%) and eight of 33 (24.2%) subjects had the occasional hot flush in the 10 mg and 5 mg groups, respectively (P = 0.032). In total, there were 12.9 ± 4.6 (n = 21) and 9.1 ± 3.9 (n = 18) days of irregular bleeding in the 10 mg and 5 mg groups, respectively (P = 0.009).ConclusionAccording to the study findings, a 5 mg daily dose over 9 months has a relatively better safety profile than the 10 mg dose.

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ObjectiveTo evaluate the efficacy, safety, and quality of life of 5 mg mifepristone per day compared with a placebo in treating uterine fibroids.DesignRandomized, double-blind clinical study.LocationEusebio Hernández Gynecology and Obstetrics Teaching Hospital, Havana, Cuba.SubjectsOne hundred twenty-four subjects with symptomatic uterine fibroids.TreatmentOne daily capsule of 5 mg mifepristone or a mifepristone placebo over 3 months.Variables in evaluating safetyChanges in fibroid and uterine volumes, changes in symptom prevalence and intensity, and changes in quality of life.ResultsThree 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.ConclusionThe 5 mg dosage of mifepristone presented significantly superior efficacy compared to the placebo.

Mifepristone 10 mg administered is an effective emergency contraceptive with an acceptable profile of side effects up to five days, but greater studies are necessary to verify its efficacy up to 6 days after unprotected intercourse.

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