Mifepristone 5 mg Versus 10 mg During 6 Months 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 During 6 Months for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.
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.
Inclusion Criteria:
- 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
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 versus 10 mg of mifepristone daily after six months of treatment
Outcome Time Frame:
6 months
Safety Issue:
Yes
Principal Investigator
Carbonell Josep Ll., MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mediterranea Medica S. L.
Authority:
Cuba: Scientific and Ethics Committee
Study ID:
Mife_Fibroids_02
NCT ID:
NCT00886873
Start Date:
May 2008
Completion Date:
April 2009
Related Keywords:
- Uterine Fibroids
- Uterine fibroids
- Mifepristone
- Antiprogestins
- Leiomyoma
- Myofibroma
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