Drug May Shrink Uterine Fibroids, Improve Quality of Life
NIH-Sponsored Study Tests Low-Dose Mifepristone to Treat Symptoms
March 01, 2004
Based on results of a pilot study, physicians at the University of Rochester Medical Center are launching a large-scale trial of the medication mifepristone, also known as RU486, to shrink uterine fibroids and improve the quality of life for women who have fibroids with troublesome symptoms. This National Institutes of Health-sponsored trial is led by Kevin Fiscella, M.D., M.P.H., principal investigator, and Steven Eisinger, M.D., co-investigator, who were instrumental in completing the pilot study.
Uterine fibroids – benign growths in the uterus – are a common condition in women of childbearing age and the most common reason women have hysterectomies. Though the majority of women have no symptoms from them, fibroids can wreak havoc on a woman’s quality of life, causing heavy bleeding, pain or pressure.
Uterine fibroid growth is often attributed to hormones in women, especially during childbearing years. Mifepristone is a synthetic steroid that has been shown to block the effects of the naturally occurring hormone progesterone. The pilot study, published in Obstetrics and Gynecology in February 2003, showed that low doses of mifepristone were effective in shrinking fibroids and, as a result, reducing symptoms for most women.
“Our six-month and one-year studies of this drug showed dramatic results,” says Dr. Eisinger. “Fibroids shrank by more than 50 percent on average, and women felt much better. Many women were reluctant to go off the drug at the end of the study.”
The current study will enroll 100 women, who will be followed over a six-month period, to determine the effect of low-dose mifepristone on reducing fibroid size and symptoms. To be eligible for the study, women must:
· Be 18 years of age or older
· Have not started menopause
· Have fibroids that cause symptoms
· Be available for office visits in the Rochester area over a six-month period
Study participants will receive the medication or a placebo, physical exams and study-related tests and will be compensated for their participation.
For information please call (585) 271-5588 or email Fibroid_Study@urmc.rochester.edu