The study will explore whether beginning hormone therapy in women during the menopausal transition (ages 42 to 58) protects against atherosclerosis, the major cause of heart attacks. Results from a prior study of older women called the Women's Health Initiative (WHI) estrogen plus progestin trial suggested there were few benefits of estrogen on atherosclerosis. The National Institutes of Health halted the study in 2002, but KEEPS will explore issues raised by WHI. Women in WHI were postmenopausal, with a mean age of 62.7, yet most women begin hormone treatment much younger, at the onset of menopausal symptoms.
"Once atherosclerosis is present, it is already too late to prevent it," said Yale principal investigator Hugh Taylor, M.D., associate professor in the Department of Obstetrics, Gynecology & Reproductive Sciences at Yale. "We think estrogen can help to prevent the disease if started early enough."
Prior to the WHI, most data suggested that hormone replacement therapy was associated with a high degree of protection (30 to 50 percent reductions) against coronary heart disease, mortality and osteoporotic fractures, in addition to a small increase in breast cancer risk.
The KEEPS trial is a randomized, double-blind trial of 720 women designed to provide prospective data on the risks and benefits of early menopausal hormone therapy (MHT). The Yale team is seeking 90 healthy, recently menopausal women ages 42 to 58 for the trial that will study the effects of using pill and skin patch hormone therapy.
Women interested in participating in the study may contact Diane Wall, clinical research nurse coordinator at 203-785-4739 or diane.wall@yale.edu. Local obstetrics & gynecology practitioners will also have information on study participation.
Additional information on the study can be found at www.kronosinstitute.org or www.keepstudy.org.