In brief: Trial to test hormone therapy in younger women
Trial to test hormone therapy in younger women
Researchers at several centers around the country, including Harvard Medical School's Brigham and Women's Hospital in Boston, are seeking healthy women, ages 42–58, to participate in the Kronos Early Estrogen Prevention Study (KEEPS). This five-year study, coordinated by the Kronos Longevity Research Institute, a nonprofit clinical research group based in Phoenix, will examine the effects of combined hormone therapy (estrogen plus a progestin) on heart disease prevention in recently menopausal women.
KEEPS, which will also look at quality of life and cognitive function, is designed to follow up on the landmark Women's Health Initiative (WHI). The WHI's estrogen plus progestin clinical trial was halted — early — in July 2002 after researchers determined that the risks for heart attack, stroke, and breast cancer outweighed the benefits of decreased fractures and lower colon cancer risk. However, most women in the WHI were many years past menopause, and subgroup findings suggested that recently menopausal women fared better.
According to Harvard Women's Health Watch advisory board member Dr. JoAnn Manson, "The WHI studied primarily older women at least a decade past menopause, making it difficult...to have a clear picture of the risks and benefits of the therapy in younger women." Dr. Manson is a principal investigator of both KEEPS and the WHI. Subjects in KEEPS will be younger: They'll begin therapy six months to three years after their last menstrual period. (Menopause officially begins 12 months after the last menstrual period.)