NCT00579475

The Effect of Mifepristone on Uterine Fibroids and Breast Tissue

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
DRUG	Mifegyne	tablets, 50 mg every other day
DRUG	placebo

Timeline

• Start date: 2004-11-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2007-12-24
• Last updated: 2015-05-25

Locations

1 site across 1 country: Sweden