Uterine Fibroids Clinical Trial
Official title:
Mifepristone 5 mg Versus 10 mg for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.
The objectives of this study are to estimate the efficacy and safety of the daily
administration of mifepristone 5 mg versus 10 mg for three months for the treatment of
uterine fibroids.
The hypothesis of the study is that both mifepristone doses reduce the volume of the myoma
in about 40% after 3 months of treatment.
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
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