Spots Global Cancer Trial Database for Trial of Mifepristone for Fibroids
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Trial Identification
Brief Title: Trial of Mifepristone for Fibroids
Official Title: Randomized Control Trial Of Mifepristone for Fibroids
Study ID: NCT00133705
Conditions
Study Description
Brief Summary: The purpose of this trial is to determine if low-dose mifepristone benefits women with symptomatic fibroids.
Detailed 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
University of Rochester School of Medicine & Dentistry, Rochester, New York, United States
Contact Details
Name: Kevin Fiscella, MD, MPH
Affiliation: University of Rochester School of Medicine & Dentistry
Role: PRINCIPAL_INVESTIGATOR
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