Evidence map›Paper›PMID 34736575›Full record

Trial reportMaturitas2021

Use of oral estradiol plus vaginal progesterone in healthy postmenopausal women.

Intira Sriprasert, Melissa Mert, Wendy J Mack, Howard N Hodis, Donna Shoupe

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

Trial report in Maturitas, 2021. 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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.0field-weighted citation impact, top 23% 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

2 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Review
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

5 authors at 1 institution in 1 country.

Intira SriprasertDepartment of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. Electronic address: sriprase@usc.edu.
Melissa MertDepartment of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Wendy J MackDepartment of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Atherosclerosis Research Unit, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Howard N HodisDepartment of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Atherosclerosis Research Unit, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Donna ShoupeDepartment of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Department of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
University of Southern California · US

Funding

Biologic Response of Menopausal Women to 17B-EstradiolR01AG024154 · NIA · UNIVERSITY OF SOUTHERN CALIFORNIA · PI HODIS, HOWARD NEIL · 2004 to 2012
$13.8M
MECHANISMS UNDERLYING THE AGE-RELATED ATHEROPROTECTIVE EFFECTS OF HORMONE THERAPYR01AG059690 · NIA · UNIVERSITY OF SOUTHERN CALIFORNIA · PI HODIS, HOWARD NEIL · 2018 to 2022
$3.6M
NIA NIH HHS R01 AG024154NIA NIH HHS R01 AG059690
6 · The paper itself

Abstract

objectivesTo compare the effect of oral estradiol (E2) plus vaginal progesterone (P4) against placebo on endometrial thickness, endometrial biopsy pathology, cervical cytology and total cancer incidence among healthy postmenopausal women. STUDY

designThis study is a sub-analysis of the Early versus Late Intervention Trial with Estradiol (ELITE), a randomized, double-blinded, placebo-controlled trial that previously demonstrated that hormone therapy (HT) was associated with less progression of subclinical atherosclerosis than placebo when therapy was initiated within 6 years after menopause but not when it was initiated 10 or more years after menopause. This sub-analysis included only ELITE participants with an intact uterus, who were randomized to either daily oral micronized 17-beta-E2 1 mg/day with 4% vaginal micronized P4 gel 45 mg/day for 10 days each month or placebo.

main outcome measuresParticipants were evaluated at baseline and annually during a median follow-up of 4.8 years for endometrial thickness as determined by pelvic transvaginal ultrasound followed by an endometrial biopsy when indicated, and cervical cytology and cancer incidence.

resultsOver up to 80 months of follow-up, participants randomized to oral E2 plus vaginal P4 had progressive and statistically significant increases in endometrial thickness (p<0.001), underwent more endometrial biopsies and had a higher rate of endometrial hyperplasia on endometrial biopsy compared with the placebo group. Due to the close follow-up of participants in the trial protocol, these abnormal findings were effectively treated.

conclusionOur results suggest that 10 days of vaginal P4 45 mg/day is insufficient to completely oppose the effect of oral E2 1 mg/day on the endometrium. Further studies are needed to test alternative doses or frequencies of administration of vaginal P4 for adequate endometrial protection from E2 therapy among postmenopausal women. ClinicalTrials.gov registration NCT00114517.

Indexed as

AgedDouble-Blind MethodEndometrial HyperplasiaEndometriumEstradiolEstrogensFemaleHumansIncidenceMiddle AgedPostmenopauseProgesteroneTreatment OutcomeEstradiolEstrogensProgesteroneCervical cytologyEndometriumEstradiolPostmenopauseVaginal progesterone

Identifiers

PMID34736575
PMCPMC8571490
OpenAlexW3198530316

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.