Researchers have finished designing the privately funded randomized clinical trial intended to explore the now-contrarian notion of hormone replacement: that it can, after all, thwart development of cardiovascular disease if women begin using it soon after menopause and use less of it. The study is moving forward despite recent disheartening research results that have led millions of women to abandon hormone replacement.

Beginning in September, the Kronos Early Estrogen Prevention Study (KEEPS) will enroll 90 women between 40 and 55 at each of eight participating US medical centers. KEEPS will compare a .45-mg oral dose of Premarin (conjugated horse estrogens) or a skin patch containing synthetic estradiol—said to be identical to the human ovarian estrogen—with placebo. For 10 days a month, women taking estrogen who still have a uterus will also use Prochieve, a vaginal gel containing 4% progesterone that is believed to have few systemic effects.

KEEPS' surrogate endpoints...

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