Mifepristone 10 or 5 mg for 6 Months to Treat Uterine Fibroids (Mifemyo_2)
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.
|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 During 6 Months for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.|
- Volume of the uterine leiomyomata with 5 versus 10 mg of mifepristone daily after six months of treatment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Prevalence of symptoms after 6 months treatment with 5 or 10 mg of mifepristone. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2008|
|Study Completion Date:||May 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Experimental: Group 1
Oral administration of mifepristone 5 mg daily for six months.
Experimental: Group 2
Oral administration of mifepristone 10 mg daily for six months.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00886873
|Hospital Eusebio Hernandez|
|Ciudad Habana, La Habana, Cuba, 13300|
|Principal Investigator:||Carbonell Josep Ll., MD||Mediterranea Medica S. L.|