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Clinical Trial 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


Clinical Trial 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00579475
Study type Interventional
Source Karolinska Institutet
Contact
Status Completed
Phase Phase 1
Start date November 2004
Completion date June 2007

See also
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