Elite LogoELITE was designed to specifically test the timing hypothesis, 643 postmenopausal women have been randomized to a 2×2, double-blind, placebo-controlled, single-center trial according to time-since-menopause. Women without pre-existing clinical cardiovascular disease <6 years- and >10 years-since-menopause were randomized to oral estradiol (1 mg/d) or placebo (with vaginal progesterone gel or placebo for 10 days each month) in each stratum. The primary trial end point is CIMT progression measured every 6 months. The secondary trial end point is rate of cognitive decline. Based on the wealth of evidence that accumulated since 2003 in support of the initial ELITE proposal to the NIH of the timing hypothesis, a 3-year extension of the trial was awarded. The three specific aims of the ELITE extension include: 1) increased randomized treatment for an average of 5 years; 2) addition of a secondary vascular end point using non-contrast and contrast cardiac computed tomography to non-invasively measure coronary artery calcium and coronary artery lesions; and, 3) addition of a third cognitive assessment to extend measurement of cognitive decline over an average of 5 years. Primary trial results from ELITE are expected in 2013. The primary trial end point is progression of CIMT measured every year by the same methodology and technology as used in ELITE. Although women were screened for coronary artery calcium at baseline and excluded if their Agatston score was >50 U, repeat coronary artery calcium measurements will be determined at end of study and progression and incident coronary artery calcium determined as a secondary end point.

Funding source

ELITE was funded by the National Institutes of Health; enrollment initiated in 2004.
Registered in clinicaltrials.gov NCT00114517