ELITE: Early Versus Late Intervention Trial With Estradiol
NCT ID: NCT00114517
Last Updated: 2023-01-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
643 participants
INTERVENTIONAL
2004-07-31
2013-03-05
Brief Summary
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Detailed Description
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A total of 643 (actual; 504 initially proposed) postmenopausal women were randomized according to their number of years since menopause, less than 6 years or 10 years or more, to receive either oral 17B-estradiol 1 mg daily or matching placebo. Women with a uterus will also use vaginal progesterone gel 4% (or placebo gel) the last ten days of each month. The vaginal progesterone will be distributed in a double-blinded fashion along with the randomized treatment so that only women exposed to active treatment will receive active progesterone. As initially proposed, participants will undergo ultrasonography at baseline and every 6 months throughout the 2 to 5 years (average 3 years) of randomized treatment. Participants will also undergo cognitive testing at baseline and after 3 years of randomized treatment. The trial has been extended for an additional 2 to 2.5 years of randomized treatment (overall average randomized treatment of 5 years and range of 2 to 8.5 years). Ultrasonography will continue to be collected every 6 months and upon completion of randomized treatment, participants will undergo cardiac CT for coronary artery calcium and coronary artery lesion measurements. Participants will also undergo a third cognitive testing at the completion of randomized treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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17B-estradiol
Oral 17B-estradiol 1 mg daily
17B-estradiol
Oral 17B-estradiol 1 mg daily
Placebo
Matching oral 17B-estradiol placebo daily
Placebo
Matching oral 17B-estradiol placebo daily
Interventions
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17B-estradiol
Oral 17B-estradiol 1 mg daily
Placebo
Matching oral 17B-estradiol placebo daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No period for 6 months or more
* Postmenopausal less than 6 years, OR 10 years or longer
Exclusion Criteria
* Women who have had a hysterectomy only and no oophorectomy (since time from menopause cannot be determined)
* Diabetes mellitus or fasting serum glucose 140 mg/dL or greater
* Uncontrolled hypertension (diastolic blood pressure 110 mmHg or greater)
* Thyroid disease (untreated)
* Serum creatinine greater than 2.0 mg/dL
* Plasma triglyceride levels greater than 500 mg/dL
* Life threatening disease with prognosis less than 5 years
* Cirrhosis or liver disease
* History of deep vein thrombosis or pulmonary embolism
* History of breast cancer
* Current hormone replacement therapy (HRT)
FEMALE
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
University of Southern California
OTHER
Responsible Party
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Howard N. Hodis, M.D.
Harry J. Bauer and Dorothy Bauer Rawlins Professor of Cardiology, Professor of Medicine, Population and Public Health Sciences, and Molecular Pharmacology and Toxicology, Director, Atherosclerosis Research Unit
Principal Investigators
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Howard N. Hodis, M.D.
Role: PRINCIPAL_INVESTIGATOR
Atherosclerosis Research Unit, University of Southern California
Locations
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Atherosclerosis Research Unit, University of Southern California
Los Angeles, California, United States
Countries
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References
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Hodis HN, Mack WJ, Shoupe D, Azen SP, Stanczyk FZ, Hwang-Levine J, Budoff MJ, Henderson VW. Methods and baseline cardiovascular data from the Early versus Late Intervention Trial with Estradiol testing the menopausal hormone timing hypothesis. Menopause. 2015 Apr;22(4):391-401. doi: 10.1097/GME.0000000000000343.
Hodis HN, Mack WJ, Henderson VW, Shoupe D, Budoff MJ, Hwang-Levine J, Li Y, Feng M, Dustin L, Kono N, Stanczyk FZ, Selzer RH, Azen SP; ELITE Research Group. Vascular Effects of Early versus Late Postmenopausal Treatment with Estradiol. N Engl J Med. 2016 Mar 31;374(13):1221-31. doi: 10.1056/NEJMoa1505241.
Henderson VW, St John JA, Hodis HN, McCleary CA, Stanczyk FZ, Shoupe D, Kono N, Dustin L, Allayee H, Mack WJ. Cognitive effects of estradiol after menopause: A randomized trial of the timing hypothesis. Neurology. 2016 Aug 16;87(7):699-708. doi: 10.1212/WNL.0000000000002980. Epub 2016 Jul 15.
Chen IJ, Stanczyk FZ, Sriprasert I, Karim R, Shoupe D, Kono N, Hodis HN, Mack WJ. Sex steroid hormones and subclinical atherosclerosis progression in postmenopausal women. Eur J Endocrinol. 2025 Mar 3;192(3):248-256. doi: 10.1093/ejendo/lvaf032.
Lin F, Pa J, Karim R, Hodis HN, Han SD, Henderson VW, St John JA, Mack WJ. Subclinical carotid artery atherosclerosis and cognitive function in older adults. Alzheimers Res Ther. 2022 May 7;14(1):63. doi: 10.1186/s13195-022-00997-7.
Sriprasert I, Mert M, Mack WJ, Hodis HN, Shoupe D. Use of oral estradiol plus vaginal progesterone in healthy postmenopausal women. Maturitas. 2021 Dec;154:13-19. doi: 10.1016/j.maturitas.2021.09.002. Epub 2021 Sep 5.
Sriprasert I, Kono N, Karim R, Hodis HN, Stanczyk FZ, Shoupe D, Mack WJ. Factors Associated With Serum Estradiol Levels Among Postmenopausal Women Using Hormone Therapy. Obstet Gynecol. 2020 Oct;136(4):675-684. doi: 10.1097/AOG.0000000000004006.
Sriprasert I, Mack WJ, Hodis HN, Allayee H, Brinton RD, Karim R. Effect of ApoE4 Genotype on the Association Between Metabolic Phenotype and Subclinical Atherosclerosis in Postmenopausal Women. Am J Cardiol. 2019 Oct 1;124(7):1031-1037. doi: 10.1016/j.amjcard.2019.06.022. Epub 2019 Jul 15.
Sriprasert I, Hodis HN, Karim R, Stanczyk FZ, Shoupe D, Henderson VW, Mack WJ. Differential Effect of Plasma Estradiol on Subclinical Atherosclerosis Progression in Early vs Late Postmenopause. J Clin Endocrinol Metab. 2019 Feb 1;104(2):293-300. doi: 10.1210/jc.2018-01600.
Karim R, Stanczyk FZ, Brinton RD, Rettberg J, Hodis HN, Mack WJ. Association of endogenous sex hormones with adipokines and ghrelin in postmenopausal women. J Clin Endocrinol Metab. 2015 Feb;100(2):508-15. doi: 10.1210/jc.2014-2834. Epub 2014 Nov 18.
Henderson VW. Aging, estrogens, and episodic memory in women. Cogn Behav Neurol. 2009 Dec;22(4):205-14. doi: 10.1097/WNN.0b013e3181a74ce7.
Other Identifiers
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AG0025
Identifier Type: -
Identifier Source: org_study_id
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