Mifepristone to Treat Uterine Fibroids

Last updated: September 4, 2014
Sponsor: Mediterranea Medica S. L.
Overall Status: Terminated

Phase

2/3

Condition

Uterine Fibroids

Leiomyomas

Desmoid Tumors

Treatment

N/A

Clinical Study ID

NCT01786226
Fibroma2.5normal
  • Ages 18-50
  • Female

Study Summary

Objectives: to evaluate the efficacy, safety and quality of life by using 2.5 and mifepristone 5 mg daily doses to treat uterine fibroids over 3 months with a 9 months follow-up period.

The hypothesis of the study is that the 2.5 mg dosage resulted in a lesser reduction in fibroid size but a similar improvement in quality of life when compared to the 5 mg dose.

Eligibility Criteria

Inclusion

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 thetreatment 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 thefollowing 10 days after treatment termination

Exclusion

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

Study Design

Total Participants: 220
Study Start date:
March 01, 2010
Estimated Completion Date:
March 31, 2012

Study Description

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.

Connect with a study center

  • Hospital Eusebio Hernández

    Ciudad Habana, Havana 11400
    Cuba

    Site Not Available

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