Project: Research project

Project Details


DESCRIPTION: (Adapted from Applicant's Abstract). 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 date4/7/973/31/98


  • Eunice Kennedy Shriver National Institute of Child Health and Human Development

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