Evidence map›Paper›PMID 25380275›Full record

Trial reportMenopause (New York, N.Y.)2015

Methods and baseline cardiovascular data from the Early versus Late Intervention Trial with Estradiol testing the menopausal hormone timing hypothesis.

Howard N Hodis, Wendy J Mack, Donna Shoupe, Stanley P Azen, Frank Z Stanczyk, Juliana Hwang-Levine, Matthew J Budoff, Victor W Henderson

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Menopause (New York, N.Y.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00114517 (Biologic Response of Menopausal Women to 17B-Estradiol), which is not on this map. Cited by 79 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
79citing papers in PubMed, 4 pooled it
8.8field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00114517 phase2completednot on this map

Biologic Response of Menopausal Women to 17B-Estradiol

TypeinterventionalSponsorUniversity of Southern CaliforniaRan2004 to 2013Enrolled643ConditionsAtherosclerosisArms17B-estradiol, Placebo
3 · Its place in the literature

Who cites it

79 citing papers in PubMed, 4 syntheses or guidelines pooled it, 148 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
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  4. Long-term hormone therapy for perimenopausal and postmenopausal women.The Cochrane database of systematic reviews · 2017
    Pooled it
  5. Effect of hormone therapy on tryptophan metabolism and atherosclerosis among postmenopausal women.Climacteric : the journal of the International Menopause Society · 2025
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  20. Air pollution and depression symptoms in middle-aged and older adults in Los Angeles County.International archives of occupational and environmental health · 2025
    Article

19 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Howard N HodisFrom the 1Atherosclerosis Research Unit, Keck School of Medicine, University of Southern California, Los Angeles, CA; 2Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA; 3Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA; 4Department of Molecular Pharmacology and Toxicology, School of Pharmacy, University of Southern California, Los Angeles, CA; 5Department of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California, Los Angeles, CA; 6Los Angeles Biomedical Research Institute at Harbor-University of California at Los Angeles Medical Center, Torrance, CA; and 7Departments of Health Research and Policy (Epidemiology) and Neurology and Neurological Sciences, Stanford University, Stanford, CA.
Wendy J Mack
Donna Shoupe
Stanley P Azen
Frank Z Stanczyk
Juliana Hwang-Levine
Matthew J Budoff
Victor W Henderson
University of Southern California · USStanford University · USThe Lundquist Institute · US

Funding

Biologic Response of Menopausal Women to 17B-EstradiolR01AG024154 · NIA · UNIVERSITY OF SOUTHERN CALIFORNIA · PI HODIS, HOWARD NEIL · 2004 to 2012
$13.8M
NIA NIH HHS R01 AG024154NIA NIH HHS R01-AG024154-01-05NIA NIH HHS R01-AG024154-06-08NIA NIH HHS R01-AG024154-S2
6 · The paper itself

Abstract

objectiveThis study aims to present methods and baseline data from the Early versus Late Intervention Trial with Estradiol (ELITE), the only clinical trial designed to specifically test the timing hypothesis of postmenopausal hormone therapy (HT). The timing hypothesis posits that HT effects depend on the temporal initiation of HT relative to time since menopause.

methodsELITE is a randomized, double-blind, placebo-controlled trial with a 2 × 2 factorial design. Six hundred forty-three healthy postmenopausal women without cardiovascular disease were randomized to oral estradiol or placebo for up to 6 to 7 years according to time since menopause (<6 or ≥10 y). Carotid artery intima-media thickness (CIMT) and cardiac computed tomography were conducted to determine HT effects on subclinical atherosclerosis across menopause strata.

resultsParticipants in the early and late postmenopausal strata were well-separated by mean age (55.4 vs 65.4 y) and median time since menopause (3.5 vs 14.3 y). Expected risk factors (age, blood pressure, and body mass index) were associated with CIMT at baseline in both strata. In the early postmenopausal group, but not in the late postmenopausal group, we observed significant associations between CIMT and factors that may play a role in the responsiveness of atherosclerosis progression according to timing of HT initiation. These include low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, sex hormone-binding globulin, and serum total estradiol.

conclusionsThe ELITE randomized controlled trial is timely and unique. Baseline data indicate that ELITE is well-positioned to test the HT timing hypothesis in relation to atherosclerosis progression and coronary artery disease.

Indexed as

Administration, OralAtherosclerosisBlood PressureBody Mass IndexCarotid ArteriesCarotid Intima-Media ThicknessCoronary Artery DiseaseDouble-Blind MethodEstradiolEstrogen Replacement TherapyEstrogensFemaleHumansLipidsMenopauseRisk FactorsEstradiolEstrogensLipids

Identifiers

PMID25380275
PMCPMC4376597
OpenAlexW2023110657

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.