Uterine Fibroids Clinical Trial
Official title:
Mifepristone 5 mg Versus 10 mg During 6 Months 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 for 6 months of 5 mg versus 10 mg. A 6 month follow-up of subjects is carried
out to estimate how the effects of mifepristone are kept in time.
The hypothesis of this study is that both mifepristone doses reduce the volume of the myoma
up to 50% in six months treatment.
Women, in fertile age or premenopausal status, presenting symptomatic myomaswere randomly
assigned to receive 5 or 10 mg of mifepristone for six months.
The decreasing in the prevalence of symptoms attributable to myomas is an important goal to
achieve under both treatments. Another goal is to maintain for more than 6 months the
benefits of the treatment with mifepristone.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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