Mifepristone 5 mg Versus 10 mg for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.
Women, in fertile age or in premenopausal status, presenting symptomatic uterine fibroids
were randomly assigned to receive 5 mg or 10 of mifepristone.
The diminishing of prevalence of symptoms attributable to uterine fibroids is the most
important goal to achieve under both treatments. The possible side effects of mifepristone
are slight and women's adherence to treatment is remarkable. Also the reduction of the
volumes of the uterus and fibroids contribute to enhance the wellbeing of subjects.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Volume of the uterine leiomyomata with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment
Josep LL. Carbonell, MD
Cuba: Scientific and Ethics Committee