Mifepristone 2.5 mg versus 5 mg daily in the treatment of leiomyoma before surgery.

Objectives: To evaluate the efficacy and safety of 2.5 mg and 5 mg mifepristone during 3 months for the treatment of uterine fibroids before surgery. Design: Multicenter randomized clinical trial. Locations: Eusebio Hernández Hospital, Havana, Cuba and the Alemán Hospital, Managua, Nicaragua. Subjects: Included in the study were 146 women with symptomatic uterine fibroids. Treatment: Group 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 efficacy: Increase in average hemoglobin, changes in fibroid and uterine volume, and symptomatic improvement. Results: The 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. Conclusion: The dose to be used should be 5 mg. [ABSTRACT FROM AUTHOR]
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