BWH Begins Recruitment for Trial to Learn More about Hormone Therapy among Younger Women
New, five-year study will focus on effects of hormone therapy on the progression of heart disease and on quality of life in recently menopausal women
BOSTON - Brigham and Women’s Hospital (BWH) is now recruiting for the Kronos Early Estrogen Prevention Study (KEEPS). The study, which focuses on the effects of hormone therapy (HT) as it relates to the progression of hardening of the arteries (atherosclerosis) in recently menopausal women, is designed to help clarify the health benefits of HT in this population. Other key goals are to look at quality of life and cognitive function.help to better define the role of estrogen and progestin in recently menopausal women.”
KEEPS is a randomized, placebo-controlled, double-blind trial of 720 recently menopausal women ages 42 to 58 (each of the eight study centers will recruit 90 women). The study is designed to provide data on the risks and benefits of HT when started within three years of menopause onset particularly as it relates to the progression of atherosclerosis. Recent studies, including subgroup analysis in the WHI, suggest that recently menopausal women have better outcomes from hormone therapy than older women. The results of the WHI estrogen plus progestin trial – which was halted by the National Institutes of Health in July 2002 due to indications that the therapy increased an older woman’s risk of heart attack, stroke and breast cancer despite decreasing fractures and colon cancer – prompted a consortium of health researchers to study the risks and benefits of HT in a younger subset of women who recently entered menop
“Findings from the Women’s Health Initiative (WHI) have been instrumental in our understanding of women’s health after menopause,” said JoAnn E. Manson, MD, DrPH, chief of the Division of Preventive Medicine at BWH and the Elizabeth F. Brigham Professor of Women’s Health at Harvard Medical School. “However, the WHI studied primarily older women at least a decade past menopause, making it difficult for healthcare providers to have a clear picture of the risks and benefits of the therapy in younger women. We hope that this trial, and the women who participate in it, will ause. KEEPS is designed to explore issues raised by the WHI, specifically:
· Does beginning HT earlier (six months to three years since last menstrual period) protect women against atherosclerosis, the major cause of heart attacks?
· Is natural human estrogen, estradiol, delivered through the skin via a patch equally effective as and potentially safer than oral estrogen?
· Does low-dose estrogen, by either pill or patch, improve quality of life and cognitive function in recently menopausal women?
To learn more about the Boston-based trial, including study design and enrollment, contact (617) 732-9870.
Please contact BWH Media Relations for more information at (617) 534-1600 or BWHMediaRelations@partners.org.
BWH is a 747-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare System, an integrated health care delivery network. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832 and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives, dedication to educating and training health care professionals, and strength in biomedical research. With $370M in funding and more than 500 research scientists, BWH is an acclaimed leader in clinical, basic and epidemiological investigation - including the landmark Nurses Health Study, Physicians Health Studies, and the Women's Health Initiative. For more information visit www.brighamandwomens.org
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