Bioidentical Hormones - U.S. Senate Special Committee on Aging
Bioidentical Hormones - U.S. Senate Special Committee on Aging
Bioidentical Hormones - U.S. Senate Special Committee on Aging
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209<br />
trllUCeJ I nal: ELI I h: Early Versus Late Interventi<strong>on</strong> Trial With Estruadiol<br />
ClinicalTrials.gov Ln s s<br />
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Purpose<br />
ELITE: Early Versus Late Interventi<strong>on</strong> Trial With Estradiol<br />
This study is currently recruiting patients.<br />
Verified by Natiosal Institute <strong>on</strong> <strong>Aging</strong> (NIA) February 207<br />
Sp<strong>on</strong>sored by: Nati<strong>on</strong>al Institute <strong>on</strong> Ating (NIAl<br />
Informati<strong>on</strong> provided by: Nati<strong>on</strong>al Institute <strong>on</strong> <strong>Aging</strong> (NIA)<br />
ClinicalTrials.gov Identifier: NCTOOI 14517<br />
aW fmeanr<br />
The purpose of tiis study is to examine the effects of 17B-estradiol (estrogen) <strong>on</strong> the progressi<strong>on</strong> of early<br />
atherosclerosis in postmenopausal women.<br />
lC<strong>on</strong>ditl<strong>on</strong> D interventi<strong>on</strong> IPhase<br />
Atherosclerosis Drug: 1 7B-estradiol PihaseRi<br />
MedlinePlsj! related topics: Vascular Disses<br />
Oneticsllomse Relbence related topics: Yasclariseases<br />
Ab Sout<br />
Study Type: Interventi<strong>on</strong>al<br />
Study Design: Treatment, Randomized, Double-Blind, Placebo C<strong>on</strong>trol, Factorial Assignment, Efficacy Study<br />
Official Title: Biologic Resp<strong>on</strong>se of Menopausal Wmrnen to 1 7Bt-Eradio<br />
Further study details as provided by Nati<strong>on</strong>al Institute <strong>on</strong> <strong>Aging</strong> (NIA):<br />
Primary Outcomes: rate of change of distal comm<strong>on</strong> carotid artery (CCA) far wall intima-media thickness<br />
(IMT)<br />
Sec<strong>on</strong>dary Outcomes: neurocognitive functi<strong>on</strong><br />
Expected Total Enmollment: 504<br />
Study start: July 2004; Expected completi<strong>on</strong>: June 2009<br />
The primary hypothesis to be tested is that 17B-estradiol (estrogen) will reduce the progressi<strong>on</strong> of early<br />
atherosclerosis if initiated so<strong>on</strong> after menopause when the vascular endothelium (lining of blood vessels) is<br />
relatively healthy versus later when the endothelium has lost its resp<strong>on</strong>siveness to estrogen.<br />
Ultras<strong>on</strong>ography will be used to measure the rate of change in the thickness of the carotid artery.<br />
A total of 504 postmenopausal women will be randomized according to their number of years since<br />
menopause, less than 6 years or 10 years or more, to receive either oral I 7B-estradiol I mg daily or a<br />
placebo. Women with a uterus will also use vaginal progester<strong>on</strong>e gel 4% (or a placebo gel) the last ten<br />
days of each m<strong>on</strong>th. The vaginal progester<strong>on</strong>e will be distributed in a double-blind fashi<strong>on</strong> al<strong>on</strong>g with the