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Mifepristone 5 mg Versus 10 mg for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.

Phase 2/Phase 3
18 Years
50 Years
Not Enrolling
Uterine Fibroids

Thank you

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:


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:


Principal Investigator

Josep LL. Carbonell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mediterranea Medica


Cuba: Scientific and Ethics Committee

Study ID:




Start Date:

January 2007

Completion Date:

March 2009

Related Keywords:

  • Uterine Fibroids
  • Uterine fibroids
  • mifepristone
  • antiprogestins
  • Leiomyoma
  • Myofibroma