Mifepristone for Treatment of Uterine Fibroids
Mifemyo
Mifepristone 5 mg Versus 10 mg for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.
1 other identifier
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 8, 2008
CompletedFirst Posted
Study publicly available on registry
July 10, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedApril 23, 2009
April 1, 2009
Same day
July 8, 2008
April 22, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Volume of the uterine leiomyomata with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment
3 months
Secondary Outcomes (1)
Volume of the uterus with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment
3 months
Study Arms (2)
1
EXPERIMENTALMifepristone 10 mg daily for three months
2
EXPERIMENTALMifepristone 5 mg daily for three months
Interventions
Oral administration of Mifepristone 10 mg daily for three months
Eligibility Criteria
You may qualify if:
- Symptomatic uterine leiomyomata
- Reproductive age or premenopausal
- Accepting the use of non hormonal contraception
- Conformity in keeping a monthly log of all episodes of vaginal bleeding during the treatment as well as all side effects of mifepristone
- Agreeing to have ultrasound examinations in every follow-up or evaluation visit
- Agreeing to two endometrial biopsies: one before starting treatment and another in the following 10 days after treatment termination.
You may not qualify if:
- Pregnancy or desire to become pregnant
- Breastfeeding
- Hormonal contraception or any hormonal therapy received in the last three months
- Signs or symptoms of pelvic inflammatory disease
- Adnexal masses
- Abnormal or unexplained vaginal bleeding
- Suspected or diagnosed malignant neoplastic disease
- Signs or symptoms of mental illness
- Adrenal disease
- Sickle cell anemia
- Hepatic disease
- Renal disease
- Coagulopathy
- Any other severe or important disease
- Any contraindication to receiving antiprogestins
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Eusebio Hernández
Havana, Ciudad Habana, 11400, Cuba
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Josep LL. Carbonell, MD
Mediterranea Medica
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 8, 2008
First Posted
July 10, 2008
Study Start
January 1, 2007
Primary Completion
January 1, 2007
Study Completion
March 1, 2009
Last Updated
April 23, 2009
Record last verified: 2009-04