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MENOPAUSE / REGULATORY DOCUMENTS

Hormone Therapy Label Tracker

See what each observed product label says, with its document version and date.

1 cited sources5 recorded findings16 tracked labelsStudy findings updated

AI-assisted research summary. These summaries are for general information. Read the original source for the full study and its limitations.

THE LABELS, AT A GLANCE

What the documents say.

The wording varies by product and label version. Here’s the picture across the 16 documents we track.

10

Broader warning language

The boxed warning still contains the older language.

1

Endometrial warning only

The boxed warning covers endometrial cancer only.

3

No boxed-warning section

No boxed warning appears in the observed document.

2

Not verified

The document could not be verified. Its warning status is unknown.

These are observations of label documents, not FDA approval decisions or a statement that treatment has no risks. Tracking last checked .

See the documents behind these numbers ↗
THE SHORT VERSION

What’s worth knowing.

The key findings, what they mean, and the context that matters.

THE HEADLINE TAKEAWAY

Regulatory awareness was not clearly associated with self-reported practice change

The survey did not establish a clear association between regulatory awareness and obstetricians’ and gynecologists’ self-reported change in clinical practice.

The regulatory-awareness reference category, specific regulatory issue, and timeframe are not available in this summary. As a cross-sectional survey, it cannot establish whether awareness caused practice change.

See the evidence

Regulatory awareness not associated with self-reported change in clinical practice

aOR 0.89
95% CI: 0.69-1.14

Cömert, Erhan Hüseyin et al.. Regulatory awareness, counseling priorities, and treatment choices in menopausal hormone therapy: a cross-sectional survey of obstetricians and gynecologists.. Menopause (New York, N.Y.). 2026.

Added

02

Standard hormone therapy protocol use tracked with reported practice change

Standard hormone therapy protocol use, favorable views of compounded bioidentical hormone therapy, and prioritizing patient preference were associated with reported change. Menopause patient volume had no clear link.

These findings came from a cross-sectional survey of obstetricians and gynecologists. The factors’ reference categories, patient-volume unit, and timeframe are not available in this summary, so causation cannot be established.

See the evidence

Standard hormone therapy protocol use associated with reported practice change

aOR 1.50
95% CI: 1.05-2.14

Cömert, Erhan Hüseyin et al.. Regulatory awareness, counseling priorities, and treatment choices in menopausal hormone therapy: a cross-sectional survey of obstetricians and gynecologists.. Menopause (New York, N.Y.). 2026.

Added

Favorable perceptions of compounded bioidentical hormone therapy associated with reported practice change

aOR 1.85
95% CI: 1.35-2.54

Cömert, Erhan Hüseyin et al.. Regulatory awareness, counseling priorities, and treatment choices in menopausal hormone therapy: a cross-sectional survey of obstetricians and gynecologists.. Menopause (New York, N.Y.). 2026.

Added

Patient preference prioritization associated with reported practice change

aOR 1.21
95% CI: 1.06-1.38

Cömert, Erhan Hüseyin et al.. Regulatory awareness, counseling priorities, and treatment choices in menopausal hormone therapy: a cross-sectional survey of obstetricians and gynecologists.. Menopause (New York, N.Y.). 2026.

Added

Higher menopause patient volume associated with reported practice change

aOR 1.01
95% CI: 1.00-1.01

Cömert, Erhan Hüseyin et al.. Regulatory awareness, counseling priorities, and treatment choices in menopausal hormone therapy: a cross-sectional survey of obstetricians and gynecologists.. Menopause (New York, N.Y.). 2026.

Added

Study-specific findings. Different populations, treatments and follow-up periods can produce different results.

THE RESEARCH, AS IT ARRIVES

Latest studies.

The newest findings added to this collection.
The learning from each, already distilled.

  1. STUDY 01Findings added
    TL;DR

    Regulatory awareness was not clearly associated with self-reported practice change

    The survey did not establish a clear association between regulatory awareness and obstetricians’ and gynecologists’ self-reported change in clinical practice.

    The regulatory-awareness reference category, specific regulatory issue, and timeframe are not available in this summary. As a cross-sectional survey, it cannot establish whether awareness caused practice change.

    Standard hormone therapy protocol use tracked with reported practice change

    Standard hormone therapy protocol use, favorable views of compounded bioidentical hormone therapy, and prioritizing patient preference were associated with reported change. Menopause patient volume had no clear link.

    These findings came from a cross-sectional survey of obstetricians and gynecologists. The factors’ reference categories, patient-volume unit, and timeframe are not available in this summary, so causation cannot be established.

    Study details & original results

    Cömert, Erhan Hüseyin et al.. Regulatory awareness, counseling priorities, and treatment choices in menopausal hormone therapy: a cross-sectional survey of obstetricians and gynecologists.. Menopause (New York, N.Y.). 2026.

    Regulatory awareness not associated with self-reported change in clinical practice

    aOR 0.89
    95% CI: 0.69-1.14

    Citation in The label tracker

    Standard hormone therapy protocol use associated with reported practice change

    aOR 1.50
    95% CI: 1.05-2.14

    Favorable perceptions of compounded bioidentical hormone therapy associated with reported practice change

    aOR 1.85
    95% CI: 1.35-2.54

    Patient preference prioritization associated with reported practice change

    aOR 1.21
    95% CI: 1.06-1.38

    Higher menopause patient volume associated with reported practice change

    aOR 1.01
    95% CI: 1.00-1.01

    Citation in The label tracker
1 of 1 study updates

Dates show when findings were added here, not when papers were published. Study populations and comparisons differ.

WHEN YOU WANT TO GO DEEPER
Read the product labelsEach document’s wording, version, source and date checked.

PRODUCT LABEL STATUS

What each product’s current FDA label document says about its boxed warning — read from the label itself and checked against the version published on DailyMed. A product’s status here is a fact about its label document on the date shown, not a statement about a regulatory decision.

How to read this table

In November 2025 the FDA announced it was initiating removal of boxed warnings from menopausal hormone therapy products, and it approved a first batch of six rewritten labels on 12 February 2026. Manufacturers submit labeling changes for FDA approval; the agency has published no timetable, so which products have updated labels changes over time — which is what this page tracks.

A boxed warning still being present does not mean a label is out of date. The endometrial-cancer boxed warning is retained on systemic estrogen-alone products, so a rewritten label for one of them still carries a boxed warning — covering endometrial cancer only. That is why this table reports what each warning covers rather than whether one exists.

ProductWhat its boxed warning saysLabel document
Prometrium
progesterone
Systemic progestogen-alone
No boxed warning in the current label
Label version 4, published
Published by Acertis Pharmaceuticals, LLC
Read the label on DailyMed
Checked
Divigel
estradiol gel
Systemic estrogen-alone
Boxed warning covers endometrial cancer only

Warning covers: endometrial cancer

WARNING: ENDOMETRIAL CANCER WITH UNOPPOSED ESTROGEN IN WOMEN WITH A UTERUS
Label version 31, published
Published by Vertical Pharmaceuticals, LLC
Read the label on DailyMed
Checked
Cenestin
synthetic conjugated estrogens, A
Systemic estrogen-alone
Not verified

no current FDA label record published for this product

Checked
Enjuvia
synthetic conjugated estrogens, B
Systemic estrogen-alone
Not verified

no current FDA label record published for this product

Checked
Estring
estradiol vaginal ring
Vaginal (local) estrogen
No boxed warning in the current label
Label version 7, published
Published by Pfizer Laboratories Div Pfizer Inc
Read the label on DailyMed
Checked
Bijuva
estradiol/progesterone
Systemic estrogen + progestogen
No boxed warning in the current label
Label version 13, published
Published by Mayne Pharma LLC
Read the label on DailyMed
Checked
Premarin
conjugated estrogens
Systemic estrogen-alone
Boxed warning still carries the pre-2026 language

Warning covers: breast cancer, cardiovascular disorders, endometrial cancer, lowest dose, shortest duration, probable dementia

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA
Label version 37, published
Published by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Read the label on DailyMed
Checked
Prempro
conjugated estrogens/medroxyprogesterone
Systemic estrogen + progestogen
Boxed warning still carries the pre-2026 language

Warning covers: breast cancer, cardiovascular disorders, endometrial cancer, lowest dose, shortest duration, probable dementia

WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER and PROBABLE DEMENTIA
Label version 39, published
Published by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Read the label on DailyMed
Checked
Estrace Vaginal Cream
estradiol vaginal cream
Vaginal (local) estrogen
Boxed warning still carries the pre-2026 language

Warning covers: breast cancer, cardiovascular disorders, endometrial cancer, lowest dose, shortest duration, probable dementia

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA
Label version 25, published
Published by Allergan, Inc.
Read the label on DailyMed
Checked
Climara
estradiol transdermal system
Systemic estrogen-alone
Boxed warning still carries the pre-2026 language

Warning covers: breast cancer, cardiovascular disorders, endometrial cancer, lowest dose, shortest duration, probable dementia

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA and BREAST CANCER
Label version 25, published
Published by Bayer HealthCare Pharmaceuticals Inc.
Read the label on DailyMed
Checked
Climara Pro
estradiol/levonorgestrel transdermal system
Systemic estrogen + progestogen
Boxed warning still carries the pre-2026 language

Warning covers: breast cancer, cardiovascular disorders, endometrial cancer, lowest dose, shortest duration, probable dementia

WARNING: CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER, and ENDOMETRIAL CANCER
Label version 27, published
Published by Bayer HealthCare Pharmaceuticals Inc.
Read the label on DailyMed
Checked
Vivelle-Dot
estradiol transdermal system
Systemic estrogen-alone
Boxed warning still carries the pre-2026 language

Warning covers: breast cancer, cardiovascular disorders, endometrial cancer, lowest dose, shortest duration, probable dementia

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, and BREAST CANCER
Label version 17, published
Published by Sandoz Inc
Read the label on DailyMed
Checked
Vagifem
estradiol vaginal inserts
Vaginal (local) estrogen
Boxed warning still carries the pre-2026 language

Warning covers: breast cancer, cardiovascular disorders, endometrial cancer, lowest dose, shortest duration, probable dementia

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, and BREAST CANCER
Label version 22, published
Published by Novo Nordisk
Read the label on DailyMed
Checked
Imvexxy
estradiol vaginal inserts
Vaginal (local) estrogen
Boxed warning still carries the pre-2026 language

Warning covers: breast cancer, cardiovascular disorders, endometrial cancer, lowest dose, shortest duration, probable dementia

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, and BREAST CANCER
Label version 13, published
Published by Mayne Pharma LLC
Read the label on DailyMed
Checked
Activella
estradiol/norethindrone acetate
Systemic estrogen + progestogen
Boxed warning still carries the pre-2026 language

Warning covers: breast cancer, cardiovascular disorders, endometrial cancer, lowest dose, shortest duration, probable dementia

WARNING: CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER, and ENDOMETRIAL CANCER
Label version 18, published
Published by Amneal Pharmaceuticals LLC
Read the label on DailyMed
Checked
Angeliq
drospirenone/estradiol
Systemic estrogen + progestogen
Boxed warning still carries the pre-2026 language

Warning covers: breast cancer, cardiovascular disorders, endometrial cancer, lowest dose, shortest duration, probable dementia

WARNING: CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER, and ENDOMETRIAL CANCER
Label version 20, published
Published by Bayer HealthCare Pharmaceuticals Inc.
Read the label on DailyMed
Checked

All 16 tracked products last checked .

How this table is produced

Each row is copied from FDA-published product labeling: retrieved from openFDA, then confirmed against the authoritative label document published by the National Library of Medicine (DailyMed) at the version shown — the warning text quoted above is verified to appear in that document before the row is written. No text here is model-generated or paraphrased.

Label documents are not journal articles: they carry no DOI, are not peer reviewed, and cannot be retracted, so the citation and retraction checks that apply to the study findings elsewhere on this monitor do not apply here. When a product cannot be verified, the table says so instead of guessing. This page is AI-assembled and has not been reviewed by a clinician — it is not medical advice, and a drug’s label is the authority, not this summary of it.

See all 5 findingsOriginal results, comparisons and study details.
1 of 1 source groupsFindings stay together with their study.
SOURCE 015 findings

Cömert, Erhan Hüseyin et al.. Regulatory awareness, counseling priorities, and treatment choices in menopausal hormone therapy: a cross-sectional survey of obstetricians and gynecologists.. Menopause (New York, N.Y.). 2026.

Regulatory awareness not associated with self-reported change in clinical practice

Added
aOR 0.8995% CI: 0.69-1.14Source [1]

Standard hormone therapy protocol use associated with reported practice change

Added
aOR 1.5095% CI: 1.05-2.14Source [1]
All 5 findings from this source

Favorable perceptions of compounded bioidentical hormone therapy associated with reported practice change

Added
aOR 1.8595% CI: 1.35-2.54Source [1]

Patient preference prioritization associated with reported practice change

Added
aOR 1.2195% CI: 1.06-1.38Source [1]

Higher menopause patient volume associated with reported practice change

Added
aOR 1.0195% CI: 1.00-1.01Source [1]
Browse the 1 original sourcesThe full bibliography behind this monitor.
  1. [1]

    Cömert, Erhan Hüseyin et al.. Regulatory awareness, counseling priorities, and treatment choices in menopausal hormone therapy: a cross-sectional survey of obstetricians and gynecologists.. Menopause (New York, N.Y.). 2026.

    Open original source in a new tab
ABOUT THIS MONITOR

The evidence, with its limits.

Study findings are generated with AI assistance and have not been reviewed by a clinician. The date on each finding records when it was added to this monitor; it is not the publication date or a clinical review date.

Product-label observations are presented separately from study findings. Each label row identifies the document, version and date checked.

This monitor does not offer individual treatment advice. Bring personal health questions to a qualified clinician.