Viewing Study NCT00133705



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Last Modification Date: 2024-10-26 @ 9:13 AM
Study NCT ID: NCT00133705
Status: COMPLETED
Last Update Posted: 2023-09-25
First Post: 2005-08-22

Brief Title: Trial of Mifepristone for Fibroids
Sponsor: University of Rochester
Organization: University of Rochester

Study Overview

Official Title: Randomized Control Trial Of Mifepristone for Fibroids
Status: COMPLETED
Status Verified Date: 2023-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None