Mifepristone 5 mg Versus 10 mg During 6 Months for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.
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
Volume of the uterine leiomyomata with 5 versus 10 mg of mifepristone daily after six months of treatment
Carbonell Josep Ll., MD
Mediterranea Medica S. L.
Cuba: Scientific and Ethics Committee