A study evaluating the effect of mifepristone (RU-486) for the treatment of leiomyomata uteri

BACKGROUND: To estimate the efficacy of daily administration of 25 mg mifepristone for the treatment of uterine leiomyoma. MATERIALS AND METHODS: A total of 30 women were to receive 25 mg mifepristone daily for a period of 6 months. Abdominal ultrasonography was performed before treatment, at 3 months and after 6 months, to evaluate the leiomyoma size and uterine volume. Endometrial biopsy was done after the treatment. Efficacy was estimated by the reduction in leiomyoma size, uterine volume, and improvement in quality of life. RESULTS: After 180 days of treatment, there was a 47% decrease in the leiomyoma volume and a 53% decrease in the uterine volume. Symptomatic improvement was noted. Twenty-three of 30 women (75.7%) became amenorrheic after the treatment. Endometrial biopsy after treatment revealed simple hyperplasia in two of 30 women. CONCLUSION: 25 mg mifepristone produces reduction in leiomyoma size and uterine volume and produces symptomatic improvement in women with fibroids.