Skip to main content
OpenTrials
Completed

NCT Number: NCT00712595

Mifepristone for Treatment of Uterine Fibroids

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Uterine Fibroids Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Eusebio Hernández

Havana, Ciudad Habana, 11400, Cuba

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mifepristone

Drug

Oral administration of Mifepristone 10 mg daily for three months

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

Primary outcomes

  1. Volume of the uterine leiomyomata with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment

    Time frame: 3 months

Secondary outcomes

  1. Volume of the uterus with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Mediterranea Medica S. L.

Other

Registry information

Official study title

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

Acronym: Mifemyo

Important dates

Study start
2007
Primary completion
2007
Study completion
2009
First posted
Jul 10, 2008
Registry last updated
Apr 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.