Evidence map›Paper›PMID 32769757›Full record

Trial reportMenopause (New York, N.Y.)2020

Effect of the neurokinin 3 receptor antagonist fezolinetant on patient-reported outcomes in postmenopausal women with vasomotor symptoms: results of a randomized, placebo-controlled, double-blind, dose-ranging study (VESTA).

Nanette Santoro, Arthur Waldbaum, Samuel Lederman, Robin Kroll, Graeme L Fraser, Christopher Lademacher, Laurence Skillern, James Young, Steven Ramael

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Menopause (New York, N.Y.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
4.8field-weighted citation impact, top 4% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 64 citations in OpenAlex.

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  4. Menopausal hormone therapy and comprehensive postmenopausal care in gynecologic cancer survivors: A position paper from the FIGO Committee on Women at Menopausal Age.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 2 countries.

Nanette SantoroUniversity of Colorado School of Medicine, Aurora, CO.
Arthur WaldbaumDowntown Women's Healthcare, Denver, CO.
Samuel LedermanAltus Research, Lake Worth, FL.
Robin KrollSeattle Women's: Health, Research, Gynecology, Seattle, WA.
Graeme L FraserOGEDA SA, subsidiary of Astellas Pharma, Inc., Gosselies, Belgium.
Christopher LademacherAstellas Pharma US, Inc., Northbrook, IL.
Laurence SkillernAstellas Pharma Europe Ltd, Chertsey, UK.
James YoungAstellas Pharma US, Inc., Northbrook, IL.
Steven RamaelOGEDA SA, subsidiary of Astellas Pharma, Inc., Gosselies, Belgium.
Astellas Pharma (United States) · USAstellas Pharma (United Kingdom) · GBDowntown Women's Health Care · USSeattle Reproductive Medicine · USUniversity of Colorado Denver · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveIn the primary analysis of the phase 2b VESTA study, oral fezolinetant reduced frequency and severity of menopausal vasomotor symptoms (VMS) compared with placebo. This secondary analysis evaluates effects of fezolinetant on responder rates and patient-reported outcomes (PROs).

methodsIn this 12-week, double-blind study, postmenopausal women with moderate/severe VMS were randomized to fezolinetant 15, 30, 60, or 90 mg BID or 30, 60, or 120 mg QD or placebo. Proportion of responders was based on reductions in VMS from daily diary records. P values for comparisons between active treatment and placebo were calculated using logistic regression. Changes from baseline in PROs (Menopause-Specific Quality of Life questionnaire, Hot Flash-Related Daily Interference Scale, Greene Climacteric Scale) were conducted using a mixed model for repeated measurements and compared post hoc with published minimally important differences (MIDs).

resultsOf 356 women randomized, 352 were treated and analyzed. A greater proportion of women receiving fezolinetant versus placebo met definitions of response at week 12. For all doses, mean changes from baseline in Menopause-Specific Quality of Life questionnaire VMS scores exceeded the MID (1.2) at weeks 4 (placebo: -1.8; fezolinetant: range, -1.9 to -3.6) and 12 (placebo: -2.3; fezolinetant: range, -2.9 to -4.4). Mean changes in Hot Flash-Related Daily Interference Scale at weeks 4 (placebo: -2.2; fezolinetant: range, -2.5 to -3.8) and 12 (placebo: -2.9; fezolinetant: range, -3.3 to -4.3) exceeded the MID (1.76). Greene Climacteric Scale-VMS domain scores improved for most fezolinetant doses versus placebo (week 4, placebo: -1.7; fezolinetant: range, -2.1 to -3.3; week 12, placebo: -2.1; fezolinetant: range, -2.7 to -3.6).

conclusionsOral fezolinetant was associated with higher responder rates than placebo and larger improvements in QoL and other PRO measures, including a reduction in VMS-related interference with daily life.

Indexed as

Quality of LifeReceptors, Neurokinin-3Double-Blind MethodFemaleHeterocyclic Compounds, 2-RingHot FlashesHumansMenopausePatient Reported Outcome MeasuresPostmenopauseThiadiazolesTreatment OutcomefezolinetantHeterocyclic Compounds, 2-RingReceptors, Neurokinin-3Thiadiazoles

Identifiers

PMID32769757
PMCPMC7709922
OpenAlexW3047268704

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.