Hormone therapy goes on trial again in UCSF study of women in early menopause

By Stephanie Levin

Marcelle I. Cedars, MD -----

Researchers at UCSF Medical Center are about to embark on a study with a controversial theme: Despite its bad reputation at present, can hormone therapy (HT) after menopause protect women from heart disease.

“Heart disease is still the nation’s leading killer of women, and we need to understand how the disease develops in women,” said lead investigator Marcelle Cedars, MD, director of the Division of Reproductive Endocrinology in the UCSF Department of Obstetrics, Gynecology and Reproductive Sciences.

UCSF is one of eight centers nationwide participating in the Kronos Early Estrogen Prevention Study, known as KEEPS, which is being by coordinated by the Phoenix-based Kronos Longevity Research Institute.

UCSF is recruiting 90 healthy, recently menopausal women who have not had a hysterectomy, are six months to three years from their last menses, and are 42 to 58 years of age.

KEEPS is a randomized, placebo-controlled, double-blind trial of 720 women designed to provide prospective data on the risks and benefits of HT in women who have recently begun menopause. Of particular interest is the role of estrogen during menopause as it relates to the progression of atherosclerosis (hardening of the arteries).

Prior to 2002, most studies suggested that HT reduced the risk of heart disease by 30 to 50 percent. But in July of that year, the widely published Women’s Health Initiative (WHI) was halted by the National Institutes of Health when results showed no preventive benefit against heart disease in women who were many years past menopause.  The WHI was a primary prevention trial of estrogen plus progestin hormone therapy in 16,608 postmenopausal women between the ages 50-79. It was the first randomized, placebo-controlled, double-blind trial of HT, and for this reason its results were believed to be nearly definitive, according to Cedars.

“Curiously, though, findings from earlier research suggest that hormone therapy may help prevent the early stages of heart attack’s precursor, atherosclerosis,” said Cedars. HT appears to be ineffective, however—or may even be harmful—once the disease is established, she added.

Knowing this, researchers hypothesized that the safety and efficacy of HT depends on exactly how and when it is delivered. They decided to study the risks and benefits of HT on a younger subset of women who recently entered menopause.

KEEPS will address questions left unanswered by the WHI trial, such as: the effectiveness of starting HT in women within three years after the last menstrual period to protect against atherosclerosis and the effectiveness of taking a lower dosage of oral estrogen or wearing a transdermal estradiol (estrogen) patch, as well at HT’s effect in improving women’s quality of life.

The eight KEEPS study centers are:

* Albert Einstein College of Medicine/Montefiore Medical Center (New York City, NY)
* Columbia University College of Physicians and Surgeons (New York City, NY)
* Harvard Medical School/Brigham and Women’s Hospital (Boston, MA)
* Mayo Clinic College of Medicine (Rochester, MN)
* University of California, San Francisco Medical Center (San Francisco, CA)
* University of Utah School of Medicine (Salt Lake City, UT)
* University of Washington School of Medicine/VA Puget Sound Health Care System (Seattle/Tacoma, WA)
* Yale University School of Medicine (New Haven, CT)

Women interested in participating in the study at UCSF should contact Nancy Jancar, RN, project director at (415) 353-4300 or [email protected] Further information on KEEPS is available online at Keep Study .

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