Neoplasms

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Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

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Mifepristone

Contraceptive Agents

Contraceptives, Oral

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Hormone Antagonists

Contraceptive Agents, Hormonal

Mifepristone 5 MG capsule taken once daily by mouth

Placebo (for Mifepristone) capsule of nearly identical color, size, and weight taken once daily by mouth

Mifepristone 5mg/day by mouth for 6 months

Inert Capsule

Kevin Fiscella, MD, MPH

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.

Trial of Mifepristone for Fibroids

Randomized Control Trial Of Mifepristone for Fibroids

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

University of Rochester

Tenured Professor

This group will receive 5 mg. capsules to be taken once daily.

Treatment Group

These women received placebo capsules identical in appearance and weight to the 5 mg. mifepristone capsule to be taken once daily.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trial of Mifepristone for Fibroids	NCT00133705	Leiomyoma	Mifepristone Inert Capsule	18 Years -	University of Rochester
Trial of Mifepristone for Fibroids	NCT00133705	Leiomyoma	Mifepristone Inert Capsule	18 Years -	University of Rochester

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