. The disease of uterine fibroids is a common and significant public health problem, affecting women of all ages, racial backgrounds and socioeconomic levels. When women with fibroids reach the perimenopausal or postmenopausal periods, they face a troubling treatment dilemma. If they wish to preserve their uterus, they take an unknown risk of causing fibroid growth by taking HRT. On the other hand, the benefits of using HRT are substantial, particularly for women at risk for cardiovascular disease or osteoporosis. There are been little, if any, research done to examine the effect of HRT use on fibroid proliferation and growth among uterine fibroid patients. The proposed randomized, controlled, double-blinded clinical trial will investigate the extent to which a commonly prescribed low dose, continuous estrogen-progestin HRT regimen stimulates fibroid growth and proliferation among black and white postmenopausal fibroid patients. Ultrasound assessments will be conducted for 300 postmenopausal fibroid patients at baseline, 6, 12 and 24 months, which will allow an examination of the extent to which fibroid growth occurs, and if so, whether growth continues or plateaus. The extent to which this HRT regimen affects menopause-related symptoms, fibroid-related symptoms and quality of life will also be examined. A risk-benefit analysis will be conducted, taking into account both uterine and non-uterine risks and benefits, based on the results of this study and reviews of other studies. The results of this study will be of significant value to a growing body of fibroid patients reaching the menopause and to the clinicians who treat these patients.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
5R01HD034482-04
Application #
6181845
Study Section
Epidemiology and Disease Control Subcommittee 2 (EDC)
Program Officer
Kaufman, Steven
Project Start
1997-04-07
Project End
2002-12-31
Budget Start
2001-01-01
Budget End
2002-12-31
Support Year
4
Fiscal Year
2001
Total Cost
$553,612
Indirect Cost
Name
University of Maryland Baltimore
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
188435911
City
Baltimore
State
MD
Country
United States
Zip Code
21201