Mifepristone for Treatment of Uterine Fibroids (Mifemyo)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Mifepristone 5 mg Versus 10 mg for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.|
- Volume of the uterine leiomyomata with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Volume of the uterus with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2007|
|Study Completion Date:||March 2009|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
Mifepristone 10 mg daily for three months
Oral administration of Mifepristone 10 mg daily for three months
Other Name: Low doses of antiprogestins to treat uterine fibroids.
Mifepristone 5 mg daily for three months
Oral administration of Mifepristone 5 mg, daily for three months
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712595
|Hospital Eusebio Hernández|
|Havana, Ciudad Habana, Cuba, 11400|
|Principal Investigator:||Josep LL. Carbonell, MD||Mediterranea Medica|