Mifepristone for Treatment of Uterine Fibroids (Mifemyo)

April 22, 2009 updated by: Mediterranea Medica S. L.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cuba
    • Ciudad Habana
      • Havana, Ciudad Habana, Cuba, 11400
        • Hospital Eusebio Hernandez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Mifepristone 10 mg daily for three months
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
Experimental: 2
Mifepristone 5 mg daily for three months
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Volume of the uterine leiomyomata with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Volume of the uterus with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mediterranea Medica S. L.

Investigators

  • Principal Investigator: Josep LL. Carbonell, MD, Mediterranea Medica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

July 8, 2008

First Submitted That Met QC Criteria

July 9, 2008

First Posted (Estimate)

July 10, 2008

Study Record Updates

Last Update Posted (Estimate)

April 23, 2009

Last Update Submitted That Met QC Criteria

April 22, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mife_Fibroids_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Uterine Fibroids

Clinical Trials on Mifepristone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe