Uterine Fibroids Clinical Trial
Official title:
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.
Objectives: to evaluate the efficacy, safety and quality of life by using 2.5 and
mifepristone 5 mg daily doses to treat uterine fibroids over 3 months with a 9 months
follow-up period.
The hypothesis of the study is that the 2.5 mg dosage resulted in a lesser reduction in
fibroid size but a similar improvement in quality of life when compared to the 5 mg dose.
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
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