Trial to test hormone therapy in younger women

(This article was first printed in the November 2005 issue of the Harvard Women's Health Watch. For more information or to order, please go to www.health.harvard.edu/womens.)

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.)

Another question raised by the WHI results: Would using a different estrogen preparation at lower doses be effective but safer? The women in the WHI who took estrogen received only one type — conjugated equine estrogen (Premarin) — in only one form (oral) and one dose. KEEPS will test low doses of both Premarin and estradiol (Climara) against a placebo. Premarin will be administered orally and Climara via skin patch. The women receiving estrogen in either form will also take Prometrium, a different progestin than the one used in the WHI, for 12 days each month, to protect against endometrial cancer.

All participants in KEEPS will be evaluated and monitored at various intervals throughout the study. The researchers plan to use noninvasive imaging tests, including ultrasound and CT scans, to measure the effects of hormone therapy on the progression of atherosclerosis (hardening of the arteries). Participating centers are located in the following areas: Boston, New Haven, New York, Rochester (Minn.), Salt Lake City, San Francisco, and Seattle. For more information, visit the Kronos Longevity Research Institute Web site (www.kronosinstitute.org or www.keepstudy.org), or call 866-878-1221 (toll free).

(This article was first printed in the November 2005 issue of the Harvard Women's Health Watch. For more information or to order, please go to www.health.harvard.edu/womens.)

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