Evidence map›Paper›PMID 40650860›Full record

Trial reportThe patient2025

Exit Interviews Examining Changes to Mood and Work/Productivity Impacts Related to Vasomotor Symptoms: Perspectives of Postmenopausal Women Receiving Elinzanetant in Phase III Clinical Trials.

Claudia Haberland, Melissa Barclay, Asha Lehane, Sophie Whyman, Adam Gater, Heidi Wikstrom, Christian Seitz, Nils Schoof, Andrew Trigg, Helena Bradley

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The patient, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07606326 (A Retrospective and Prospective Clinical Registry for Data Collection of Perimenopausal, Menopausal and Premature Ovarian Insufficiency Women), 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
–field-weighted citation impact
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.

NCT07606326 not yet recruitingnot on this mapstarted 2026, after this paper: background citation

A Retrospective and Prospective Clinical Registry for Data Collection of Perimenopausal, Menopausal and Premature Ovarian Insufficiency Women

Typeobservational_patient_registrySponsorIRCCS San RaffaeleRan2026 to 2040Enrolled5,000ConditionsMenopause, Menopausal Hormone Therapy, Menopause Surgical, Menopause Related Conditions
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
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

10 authors.

Claudia HaberlandBayer AG, Berlin, Germany.ORCID 0000-0002-5533-1881
Melissa BarclayPatient-Centered Outcomes, Adelphi Values, Cheshire, UK.ORCID 0000-0003-1822-6641
Asha LehanePatient-Centered Outcomes, Adelphi Values, Cheshire, UK.ORCID 0000-0003-1689-569X
Sophie WhymanPatient-Centered Outcomes, Adelphi Values, Cheshire, UK.
Adam GaterPatient-Centered Outcomes, Adelphi Values, Cheshire, UK.ORCID 0000-0001-9582-8596
Heidi WikstromBayer Oy, Espoo, Finland.ORCID 0000-0001-9744-8415
Christian SeitzBayer AG, Berlin, Germany.ORCID 0000-0003-2315-9148
Nils SchoofBayer AG, Berlin, Germany.ORCID 0000-0003-0343-2776
Andrew TriggMedical Affairs Statistics, Bayer plc, Reading, UK.ORCID 0000-0002-1613-8042
Helena BradleyPatient-Centered Outcomes, Adelphi Values, Cheshire, UK. Helena.bradley@adelphivalues.com.ORCID 0000-0002-7077-2183

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVasomotor symptoms (VMS; hot flashes) significantly impact women's health-related quality of life during the menopausal transition. Two phase III trials (OASIS 1 and 2) were conducted to investigate the efficacy and safety of elinzanetant for the treatment of moderate-to-severe VMS associated with menopause. This exit interview study explored the impact of VMS on women's mood and work/productivity before and since treatment.

methodsA total of 40 postmenopausal women from the USA who participated in OASIS 1 and 2 (receiving elinzanetant for 26 weeks or placebo for 12 weeks followed by elinzanetant for 14 weeks) took part in a 60-min exit interview. Interviews were conducted via telephone by trained qualitative interviewers using a semi-structured interview guide; concept-elicitation techniques, followed by focused questioning, were used to explore concepts of interest. Interview transcripts were analyzed using thematic analysis methods in Atlas.ti. Saturation analysis was conducted to determine the appropriateness of the sample size.

resultsTwelve mood concepts and seven work/productivity concepts were reported to be associated with VMS before taking the study medication. Most commonly reported mood concepts included reduced happiness (60.0%), embarrassment (50.0%), and mood swings (45.0%). Most commonly reported work/productivity concepts included reduced concentration (77.5%) and reduced productivity (67.5%). Most participants reported improvements since taking the study medication (mood: ≥ 82.4%; work/productivity: ≥ 80.0%), which contributed to other positive changes (e.g., in social wellbeing). Improvements were considered meaningful (≥ 72.2%) and highly satisfying (≥ 71.4%).

conclusionThis study provides novel insights into women's experiences of VMS-associated impacts on mood and work/productivity, highlighting the emotional and economic burdens of VMS. Data support and contextualize the treatment benefits of elinzanetant on mood and work/productivity that are meaningful to women.

Indexed as

AffectHot FlashesPostmenopauseAgedFemaleHumansInterviews as TopicMiddle AgedQuality of Life

Identifiers

PMID40650860
PMCPMC12559116

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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.