Mifepristone to Treat Uterine Fibroids

September 4, 2014 updated by: Dr. Josep Lluis Carbonell i Esteve, Mediterranea Medica S. L.

Treatment of Uterine Myoma With 2.5 or 5 mg Mifepristone Daily During 3 Months With 9 Months Post-treatment Follow-up. Randomized Clinical Trial.

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.

Study Overview

Status

Terminated

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)

220

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
    • Havana
      • Ciudad Habana, Havana, 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

18 years to 50 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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mifepristone 2.5 mg daily for three months
Experimental: 1
Drug: Oral administration of mifepristone 2.5 mg daily for three months
Experimental: 1
Other Names:
  • Low doses of antiprogestins to treat uterine fibroids
Experimental: Mifepristone 5 mg daily for three months
Experimental: 2
Drug: Oral administration of mifepristone 5 mg daily for three months
Experimental: 2
Other Names:
  • Low doses of antiprogestins to treat uterine fibroids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of the uterine leiomyomata with 2,5mg vs 5 mg daily of mifepristone after 3 months of treatment
Time Frame: 3 months
Evaluate efficacy were the percentage changes in fibroid volumes before starting, 3 into treatment and 3, 6, and 9 months after its termination
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of the uterus with 2,5 mg vs 5 md daily of mifepristone after 3 months of treatment.
Time Frame: 3 months
Evaluate efficacy were the percentage changes in uterus volumes before starting, 3 into treatment and 3, 6, and 9 months after its termination
3 months

Collaborators and Investigators

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

Sponsor

Mediterranea Medica S. L.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

March 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

February 5, 2013

First Submitted That Met QC Criteria

February 5, 2013

First Posted (Estimate)

February 7, 2013

Study Record Updates

Last Update Posted (Estimate)

September 5, 2014

Last Update Submitted That Met QC Criteria

September 4, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fibroma2.5normal

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.

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