DESCRIPTION: 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.
|Effective start/end date||4/7/97 → 12/31/02|
- National Institutes of Health
- National Institutes of Health: $553,612.00
- National Institutes of Health: $575,298.00
- National Institutes of Health: $518,012.00
Quality of Life