The Effect of Mifepristone on Uterine Fibroids and Breast Tissue

Phase 1

Completed

• Conditions: Uterine Fibroids
• Interventions: Drug: placebo; Drug: Mifegyne

• Registration Number: NCT00579475
• Lead Sponsor: Karolinska Institutet

Brief Summary

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

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 Timeline

• Study Start: 2004-11
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2007-12
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2007-12-24
• Last Update Submitted: 2015-05-22
• Last Update Posted: 2015-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
I	Mifegyne	Mifepristone (Mifegyne) 50 mg every other day for 3 months

Primary Outcome Measures

Name	Time	Method
Myoma size	2004 to 2007

Secondary Outcome Measures

Name	Time	Method
Breast epithelial cell proliferation	2004 to 2007

Trial Locations

Locations (1)

Dept of Obstetrics and Gynecology, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden