Evidence map›Paper›PMID 41582174›Full record

ReviewBiology of sex differences2026

Advancing evidence-based regulation: Organization for the Study of Sex Differences and Society for Women's Health Research support FDA action on menopausal hormone therapy and encourage broader sex-informed drug label updates.

Rebecca L Cunningham, Liisa A M Galea, Syreen Goulmamine, Georgios Kararigas, Kathryn G Schubert, Kristen L Zuloaga, Sofia B Ahmed

Abstract readReview
In one paragraph

Review in Biology of sex differences, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

2 citing papers in PubMed.

  1. Review
  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

7 authors.

Rebecca L CunninghamDepartment of Pharmaceutical Sciences College of Pharmacy, University of North Texas Health Science Center, TX, Fort Worth, USA.ORCID 0000-0001-5984-5516
Liisa A M GaleaOrganization for the Study of Sex Differences, Bandera, TX, USA.ORCID 0000-0003-2874-9972
Syreen GoulmamineSociety for Women's Health Research, Washington, D.C, USA.ORCID 0009-0008-8331-326X
Georgios KararigasEditorial Board, Biology of Sex Differences, New York City, NY, USA.ORCID 0000-0002-8187-0176
Kathryn G SchubertSociety for Women's Health Research, Washington, D.C, USA.ORCID 0000-0003-1043-9597
Kristen L ZuloagaEditorial Board, Biology of Sex Differences, New York City, NY, USA.ORCID 0000-0002-5395-7362
Sofia B AhmedOrganization for the Study of Sex Differences, Bandera, TX, USA. Sofia.Ahmed@albertahealthservices.ca.ORCID 0000-0003-3000-2229

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Menopause is an important life-stage transition with substantial implications for health and quality of life. Menopausal hormone therapy (HT) remains among the most effective treatments for menopausal symptoms, yet clinical uptake has varied markedly over time as evidence regarding benefits and risks has evolved. The Organization for the Study of Sex Differences and the Society for Women's Health Research outline our support for the US Food and Drug Administration's (FDA) removal of the "black box" warning on menopausal HT labels. This important shift in federal policy supports evidence-based menopause care and reflects an evolving, evidence-responsive regulatory practice. We further call for consistent, evidence-based FDA review of whether approved product labeling adequately incorporates sex-related differences in pharmacokinetics, pharmacodynamics, and adverse event profiles, with updates to indications, dosing, and warnings where supported by robust data.

Indexed as

Drug LabelingEstrogen Replacement TherapyHormone Replacement TherapyMenopauseSex CharacteristicsUnited States Food and Drug AdministrationWomen's HealthEvidence-Based MedicineFemaleHumansUnited States

Identifiers

PMID41582174
PMCPMC12914975

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.