Treatment of Uterine Myoma With 2.5 or 5 mg Mifepristone Daily During 3 Months With 9 Months Post-treatment Follow-up. Randomized 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: Open Label, Primary Purpose: Treatment
Volume of the uterine leiomyomata with 2,5mg vs 5 mg daily of mifepristone after 3 months of treatment
Evaluate efficacy were the percentage changes in fibroid volumes before starting, 3 into treatment and 3, 6, and 9 months after its termination
Cuba: Scientific and Ethics Committee