Trial | NCT00712595  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    mifepristone ...

  • Study Participants

    200
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.
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.
Study Started
Jan 31
2007
Primary Completion
Jan 31
2007
Study Completion
Mar 31
2009
Last Update
Apr 23
2009
Estimate

Drug Mifepristone

Oral administration of Mifepristone 10 mg daily for three months

  • Other names: Low doses of antiprogestins to treat uterine fibroids.

Drug Mifepristone

Oral administration of Mifepristone 5 mg, daily for three months

1 Experimental

Mifepristone 10 mg daily for three months

2 Experimental

Mifepristone 5 mg daily for three months

Criteria 

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
No Results Posted