The Effect of Mifepristone on Uterine Fibroids and Breast Tissue

Karolinska Institute

Status and phase: Completed; Phase 1

Conditions: Uterine Fibroids

Treatments: Drug: Mifegyne; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00579475

MPA Dnr151:2003/4444

WMB300

Details and patient eligibility

About

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

Full 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

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: placebo

I

Active Comparator group

Description:

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

Treatment:

Drug: Mifegyne