Study to explore whether hormone therapy in women during menopause protects against atherosclerosis

Researchers in The Department of Obstetrics, Gynecology & Reproductive Sciences at Yale have launched the Kronos Early Estrogen Prevention Study (KEEPS), which will further understanding of the possible beneficial effects on the heart and arteries and/or quality of life in recently menopausal women.

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.

This study is supported by the recent release of results from the Women's Health Initiative (WHI). That study initially suggested that there were few benefits of estrogen on atherosclerosis. The National Institutes of Health halted the study in 2002. Women in WHI were postmenopausal, with a mean age of 63, yet most women begin hormone treatment much younger, at the onset of menopausal symptoms. Today's study reports the results by age. The younger women, those 50 to 59-years-old, who used estrogen showed a beneficial effect on the heart.

"These findings are consistent with estrogen having a beneficial effect if used early, but a negative effect if used late," said Principal Investigator of the KEEPS trial at Yale, Hugh S. Taylor, M.D. "Estrogen seems to work by limiting the progression of atherosclerotic changes rather than treating established disease. You can't turn back the clock. Estrogen works by preventing disease, but it doesn't work if one goes for years without it. Newly menopausal women can use estrogen for relief of hot flushes and other menopausal symptoms without worrying about their heart. Women close to menopause might even see benefits for their heart."

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.

Compensation will be provided for participants accepted into the study.