The Effect of Mifepristone on Uterine Fibroids and Breast Tissue

Study Overview
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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

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

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

Conditions
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Uterine Fibroids

Intervention / Treatment
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* Drug: Mifegyne
* Drug: placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myoma size |  | 2004 to 2007 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast epithelial cell proliferation |  | 2004 to 2007 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mifepristone, leiomyomas, breast epithelial cell proliferation