Mifepristone 10 or 5 mg for 6 Months to Treat Uterine Fibroids
Mifemyo_2
Mifepristone 5 mg Versus 10 mg During 6 Months for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2008
Shorter than P25 for phase_2
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
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 22, 2009
CompletedFirst Posted
Study publicly available on registry
April 23, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedOctober 17, 2014
October 1, 2014
11 months
April 22, 2009
October 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Volume of the uterine leiomyomata with 5 versus 10 mg of mifepristone daily after six months of treatment
6 months
Secondary Outcomes (1)
Prevalence of symptoms after 6 months treatment with 5 or 10 mg of mifepristone.
6 months
Study Arms (2)
Group 1
EXPERIMENTALOral administration of mifepristone 5 mg daily for six months.
Group 2
EXPERIMENTALOral administration of mifepristone 10 mg daily for six months.
Interventions
Eligibility Criteria
You may qualify if:
- Symptomatic uterine fibroids
- 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 the side effects of mifepristone
- Agreeing to have ultrasound examinations in every follow-up or evaluation visit
- Agreeing in 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 Hernandez
Ciudad Habana, La Habana, 13300, Cuba
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carbonell Josep Ll., MD
Mediterranea Medica S. L.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director
Study Record Dates
First Submitted
April 22, 2009
First Posted
April 23, 2009
Study Start
May 1, 2008
Primary Completion
April 1, 2009
Study Completion
May 1, 2009
Last Updated
October 17, 2014
Record last verified: 2014-10