The Effect of Mifepristone on Uterine Fibroids and Breast Tissue

May 22, 2015 updated by: Karolinska Institutet

The Effect of Preoperative Treatment With Mifepristone on Uterine Fibroids and Breast Tissue

Uterine fibroids are a benign but common condition among women in reproductive age. It is one of the most common reasons for hysterectomy since it often causes bleeding problems sometimes leading to anemia. Several alternative treatment regimens have been investigated that could replace surgery. The antiprogesterone, mifepristone, is one of the most promising drugs that have been tested. In addition to the inhibiting effect on the growth of uterine fibroids antiprogestins have been proposed to have an antiproliferative effect on breast tissue.

The purpose of the present study is to evaluate the effect of mifepristone on the volume of uterine fibroids. The study will also address the effect of mifepristone on the breast tissue

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Other purposes of this study include:

  • To develop a new non-surgical method for treatment of uterine fibroids
  • To study the effect of mifepristone on the size of uterine fibroids
  • To evaluate factors regulating fibroid growth by comparison with untreated fibroids and normal myometrium
  • To study the effect of mifepristone on the amount of blood loss and pelvic pain in patients with fibroids
  • To study the effect of mifepristone on proliferation of breast tissue

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

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

  • Sweden
      • Stockholm, Sweden, SE17176
        • Dept of Obstetrics and Gynecology, Karolinska University Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Uterine fibroids requiring treatment

  • Good general health
  • Willing and able to participate after giving informed consent

Exclusion Criteria:

  • Need for immediate surgery
  • Concomitant hormonal treatment (HRT)
  • History of malignant disorder of the breast
  • Any contraindication for mifepristone

Criteria for retrospective exclusion:

Subjects may be excluded from analysis if one of the following applies:

  • Any violation of the study protocol
  • Lack of essential data

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
Active Comparator: I
Mifepristone (Mifegyne) 50 mg every other day for 3 months
Drug: Mifegyne
tablets, 50 mg every other day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Myoma size
Time Frame: 2004 to 2007
2004 to 2007

Secondary Outcome Measures

Outcome Measure
Time Frame
Breast epithelial cell proliferation
Time Frame: 2004 to 2007
2004 to 2007

Collaborators and Investigators

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

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Kristina Gemzell Danielsson, Prof.MD.PHD, Karolinska Institutet

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

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

November 1, 2004

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

December 24, 2007

Study Record Updates

Last Update Posted (Estimate)

May 25, 2015

Last Update Submitted That Met QC Criteria

May 22, 2015

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WMB300
  • MPA Dnr151:2003/4444

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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