The purpose of this trial is to determine if low-dose mifepristone benefits women with symptomatic fibroids.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
70
Mifepristone 5mg/day by mouth for 6 months
sugar pill
University of Rochester School of Medicine & Dentistry
Rochester, New York, United States
Uterine Volume
Uterine volume is measured in mLs
Time frame: 6 months
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