Conditions: Leiomyoma
Keywords: A benign tumor derived from smooth uterine muscle tissue.
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 70
Healthy volunteers: yes

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.

Arms:
arm 1: Mifepristone 5 MG capsule taken once daily by mouth arm 2: Placebo (for Mifepristone) capsule of nearly identical color, size, and weight taken once daily by mouth

Interventions: intervention 1: Mifepristone intervention 2: Inert Capsule
Intervention descriptions: intervention 1: Mifepristone 5mg/day by mouth for 6 months intervention 2: sugar pill

Protocol document: