NCT00133705

Trial of Mifepristone for Fibroids

Randomized Control Trial Of Mifepristone for Fibroids

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Leiomyoma

Interventions

Type	Name	Description
DRUG	Mifepristone	Mifepristone 5mg/day by mouth for 6 months
DRUG	Inert Capsule	sugar pill

Timeline

• Start date: 2003-07-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2005-08-23
• Last updated: 2023-09-25
• Results posted: 2012-11-30

Locations

1 site across 1 country: United States