Mifepristone 5 mg Versus 10 mg for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.
18 Years
50 Years
Female
Uterine Fibroids
Trial Information
Mifepristone 5 mg Versus 10 mg for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Volume of the uterine leiomyomata with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment
Outcome Time Frame:
3 months
Safety Issue:
Yes
Principal Investigator
Josep LL. Carbonell, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mediterranea Medica
Authority:
Cuba: Scientific and Ethics Committee
Study ID:
Mife_Fibroids_01
NCT ID:
NCT00712595
Start Date:
January 2007
Completion Date:
March 2009
Related Keywords:
- Uterine Fibroids
- Uterine fibroids
- mifepristone
- antiprogestins
- Leiomyoma
- Myofibroma
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