Mifepristone for Treatment of Uterine Fibroids (Mifemyo)
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|ClinicalTrials.gov Identifier: NCT00712595|
Recruitment Status : Completed
First Posted : July 10, 2008
Last Update Posted : April 23, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Uterine Fibroids||Drug: Mifepristone||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Mifepristone 5 mg Versus 10 mg for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||January 2007|
|Actual Study Completion Date :||March 2009|
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
- Volume of the uterine leiomyomata with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment [ Time Frame: 3 months ]
- Volume of the uterus with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712595
|Hospital Eusebio Hernández|
|Havana, Ciudad Habana, Cuba, 11400|
|Principal Investigator:||Josep LL. Carbonell, MD||Mediterranea Medica|