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Clinical Trial Summary

The purpose of this trial is to determine if low-dose mifepristone benefits women with symptomatic fibroids.


Clinical Trial Description

This trial is designed to assess the efficacy and tolerability of mifepristone 5 mg given daily for 6 months to pre-menopausal women with symptomatic fibroids. The primary study outcome will be disease-specific quality of life. Secondary outcome measures include global quality of life, pain, bleeding, potential adverse effects, tumor size, and endometrial effects. The researchers will also examine a the effect of mifepristone on uterine blood flow. Randomization of study subjects will be stratified in order to ensure that equal numbers of women with moderate and severe symptoms will be enrolled in the placebo and control groups. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00133705
Study type Interventional
Source University of Rochester
Contact
Status Completed
Phase Phase 3
Start date July 2003
Completion date June 2010

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