Mifepristone 10 or 5 mg for 6 Months to Treat Uterine Fibroids (Mifemyo_2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00886873|
Recruitment Status : Completed
First Posted : April 23, 2009
Last Update Posted : October 17, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Uterine Fibroids||Drug: Mifepristone||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Mifepristone 5 mg Versus 10 mg During 6 Months for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||May 2009|
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.
- Volume of the uterine leiomyomata with 5 versus 10 mg of mifepristone daily after six months of treatment [ Time Frame: 6 months ]
- Prevalence of symptoms after 6 months treatment with 5 or 10 mg of mifepristone. [ Time Frame: 6 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): NCT00886873
|Hospital Eusebio Hernandez|
|Ciudad Habana, La Habana, Cuba, 13300|
|Principal Investigator:||Carbonell Josep Ll., MD||Mediterranea Medica S. L.|