The Effect of Mifepristone on Uterine Fibroids and Breast Tissue

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-06-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Uterine Fibroids

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

I

Mifepristone (Mifegyne) 50 mg every other day for 3 months

Group Type ACTIVE_COMPARATOR

Mifegyne

Intervention Type DRUG

tablets, 50 mg every other day

Interventions

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Mifegyne

tablets, 50 mg every other day

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No