Tag: HRT

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Should Women Take Testosterone After Menopause?

On By Dr. Scott RennieIn Menopause & Women's HealthLeave a comment

Update, September 18, 2026: What Came Out of the FDA Workshop

The workshop happened yesterday. Nothing was approved, and approval was never on the table. What changed was the tone. Admiral Brian Christine, the Assistant Secretary for Health, opened by calling the lack of an FDA-approved testosterone product for women “unacceptable” when Australia has one. The FDA’s own position was more measured: the approval standard is the same for every drug, data from other countries will be judged case by case, and the agency says it stands ready to review an application (10).

That last point matters most. Nothing changes for patients until a company actually files. Products made for women are already approved in the UK, Australia, New Zealand and South Africa, so the data exists. The question is whether anyone brings it here.

The science presented matched what I wrote below. Dr. Rajita Patil of UCLA’s menopause program said the evidence supports testosterone for postmenopausal women with low sexual desire and is insufficient for mood, cognition or general well-being. She also cautioned against oral testosterone because of what it does to cholesterol (10).

My own practice hasn’t changed. Until there’s an approved product I can prescribe, I refer patients out. Public comments are open until October 19, 2026.

On September 17, 2026, the FDA holds its first public workshop on testosterone use in menopausal women. It is a hybrid session, in person at the agency’s White Oak campus and online at the same time, filed under docket FDA-2026-N-5479, with the public comment period open through October 19 (1). Right now, no testosterone product is FDA-approved for use in women in the United States. Every prescription written for a woman is off-label, borrowed from a product built and dosed for men. When I think a patient would benefit, my role right now is to refer her to someone who can prescribe it, not to write it myself.

That gap has been widening for a decade, and the FDA is only now catching up to it.

Why the Agency Is Paying Attention Now

Prescribing tells the story better than any regulatory notice could. Testosterone prescriptions to women in the US rose roughly 2.6-fold between 2016 and 2025, from 50.0 to 130.8 per 100,000 eligible women (2). In 2025 alone, 90,482 prescriptions went out, up 58.7 percent from the year before. About three in five, 62.2 percent, went to women between 45 and 64. More than half, 51.2 percent, already carried at least one documented cardiometabolic risk factor (2).

Rapid off-label growth in a population that already carries meaningful cardiovascular risk, for a drug whose long-term safety in women is still not established: that combination is what put a federal workshop on the calendar.

The Evidence That Actually Holds Up

Low sexual desire is where testosterone has real trial support. A 2019 systematic review and meta-analysis by Islam and colleagues in The Lancet Diabetes & Endocrinology pooled 36 randomized controlled trials and 8,480 women (3). In postmenopausal women, testosterone significantly improved desire, arousal, orgasm, and sexual pleasure, and reduced the distress that comes with low libido. The Global Consensus Position Statement, released the same year, reached the same conclusion from a different angle: the only evidence-based indication for testosterone therapy in women is hypoactive sexual desire disorder, confirmed only after a genuine biopsychosocial assessment rules out the other usual explanations, a strained relationship, untreated depression, a medication doing this to her (4).

I put it this way when the subject came up this week:

“Low desire is where the evidence is strongest, and that alone is reason not to dismiss it. A lot of women also just feel better on it. We cannot fully explain why yet, but at a physiologic dose with honest counseling about what is proven, that is a reasonable place to stand.”

What the Data Still Cannot Explain

The same Islam review found no measurable effect of testosterone on general wellbeing, cognition, body composition, or musculoskeletal outcomes. No real change in bone density. No change in lean mass or strength. The consensus statement says it plainly: no effect on general wellbeing has been demonstrated in trials to date.

That sits awkwardly next to what a lot of women report once they are actually on it: more energy, sharper focus, a sense of being back in their own body. That reported experience deserves to be taken seriously rather than waved off, and I am not going to claim an energy or cognition benefit I cannot point to a trial for either. The evidence has not caught up to the experience yet.

What a Reasonable Dose Looks Like

The goal is a physiologic premenopausal testosterone level. The dose I would want a patient on is about one-tenth of the standard male dose of a regulated 1 percent testosterone gel, roughly 5 mg applied to the skin daily, off-label since nothing is approved for women. Pellets and high-dose injections push levels into supraphysiologic territory that a properly dosed gel does not reach. Compounded products are a different problem: no consistent evidence backs their dosing, efficacy, or safety, whatever the label promises (4).

Monitoring is not complicated. Check a baseline total testosterone level, recheck at three to six weeks to confirm the dose landed where it should, and stop by six months if there is no symptomatic benefit. Formulation matters for one specific reason: oral testosterone raises LDL cholesterol, while a transdermal patch or gel leaves the lipid panel essentially untouched. Side effects run mild and cosmetic more often than dangerous, acne and unwanted hair growth chief among them. The same 2019 review also recorded an overall increase in weight with testosterone treatment. Worth knowing if weight is already part of the conversation.

Where Estrogen Usually Fits First

Estrogen treats hot flashes, night sweats, disrupted sleep, and vaginal dryness, none of which testosterone has been shown to fix, and it has a much longer safety record behind it. When I treat patients, estrogen usually comes before testosterone.

Without a need for contraception, the regimen I reach for is transdermal 17-beta-estradiol 0.025 to 0.05 mg per day, paired with micronized progesterone 100 mg nightly, continuously, if she still has a uterus. With a need for contraception, I use continuous ethinyl estradiol 20 mcg with levonorgestrel 100 mcg daily instead. About a quarter of the women I see on video visits arrive already started on hormone therapy from somewhere else, so a fair amount of my job is auditing a regimen I did not write.

Flibanserin, sold as Addyi, is worth knowing about too. On December 15, 2025, the FDA expanded its approval to cover postmenopausal women under 65 with HSDD; before that it had only been approved for premenopausal women, since 2015 (5). It is a separate, FDA-approved option aimed specifically at low desire rather than at hormone levels.

Getting Any of This Through a Screen

Testosterone is a Schedule III controlled substance. Under the DEA and HHS telemedicine flexibilities extended through December 31, 2026, a DEA-registered practitioner can currently prescribe it after a video visit alone, with no prior in-person exam, and generally without a separate DEA registration in the patient’s state, as long as both states’ laws allow it (6, 7). That is temporary: it rests on an extension already renewed four times, and the permanent replacement, a special-registration system that would keep Schedule III drugs like this one in an easier tier than Schedule II, has been in White House OMB review since August 25, 2026 with no final version yet (8, 9).

So federal law is not what stops me right now. Some telemedicine platforms do let a DEA-registered clinician prescribe controlled substances after a video visit. The platforms I work through don’t give me that ability at the moment, so when I think a patient would genuinely benefit, I refer her to an in-person clinician who can prescribe it. If that changes, or the DEA’s pending rule settles things for good, I may be able to write it myself.

For Patients

Before a video visit about this, bring your current medications and any hormone therapy already written down. Know what has changed for you, specifically, rather than a general “I don’t feel like myself.” And say what you want treatment to do: “I want my desire back” and “I want more energy” point toward different conversations, and only one has real trial data behind it.

One red flag worth knowing: pellets. The consensus statement is direct about this. Any testosterone preparation that produces supraphysiologic levels, pellets and high-dose injections included, is not recommended, in part because there is no way to adjust or remove the dose once a pellet is implanted. If a clinic is pitching pellets alongside language about restoring youthful vitality, that is worth questioning.

For Colleagues

A total testosterone level should never be the test that diagnoses HSDD. It does not correlate reliably with symptoms; this is a clinical diagnosis built on history and distress, other causes ruled out along the way. There is no data supporting use in premenopausal women, so keep the indication where the evidence lives, and screen for cardiometabolic risk before starting anything, given how much of the current prescribing population already carries it (2).

The Bottom Line

Low desire is where the evidence for testosterone is strongest in postmenopausal women, and that alone is reason not to dismiss it. Many women report feeling better on it, and nobody can fully explain why yet. If I were prescribing, the dose would be physiologic: about one-tenth of the standard male dose of a regulated 1 percent gel, roughly 5 mg on the skin daily, and estrogen usually comes first. Right now I am not the one writing that prescription. Testosterone is a Schedule III controlled substance, and the platforms I work through don’t currently let me prescribe it, so when a patient would benefit, I refer her to an in-person clinician who can. That could change once the DEA finalizes its pending rule or my platforms add the capability. The comment window on the FDA’s workshop closes October 19, 2026.

Related Reading

FDA Removes Black Box Warning From Menopause Hormone Therapy

Vaginal Dryness After Menopause: Why It Doesn’t Go Away

Does Menopause Cause Weight Gain, or Is It Just Aging?

More on Menopause & Women’s Health

Scott Rennie, D.O.
Board Certified in Obesity Medicine and Family Medicine

This blog is for educational purposes only and does not constitute individual medical advice. Always consult your own physician before making changes to your health, medications, or treatment plan.

Sources

1. FDA. Public Meeting: Testosterone Use in Menopausal Women. September 17, 2026. Docket FDA-2026-N-5479. https://www.fda.gov/consumers/womens-health-events/fda-public-meeting-testosterone-use-menopausal-women-09172026

2. Avivi I, Stuenkel CA, Sampath-Kumar R, Ben-Yehuda O. Accelerating Testosterone Prescribing for U.S. Women: Implications for Cardiovascular Safety. JACC Adv. 2026;5(6 Pt 1):102724. PMID 42095794. https://pmc.ncbi.nlm.nih.gov/articles/PMC13309321/

3. Islam RM, Bell RJ, Green S, Page MJ, Davis SR. Safety and efficacy of testosterone for women: a systematic review and meta-analysis of randomised controlled trial data. Lancet Diabetes Endocrinol. 2019;7(10):754-766. PMID 31353194. https://pubmed.ncbi.nlm.nih.gov/31353194/

4. Davis SR, Baber R, Panay N, et al. Global Consensus Position Statement on the Use of Testosterone Therapy for Women. J Clin Endocrinol Metab. 2019;104(10):4660-4666. PMID 31498871. https://pmc.ncbi.nlm.nih.gov/articles/PMC6821450/

5. Historic First in Women’s Sexual Health: FDA Grants Approval for Addyi (flibanserin) in Postmenopausal Women. BioSpace, December 15, 2025. https://www.biospace.com/press-releases/historic-first-in-womens-sexual-health-fda-grants-approval-for-addyi-flibanserin-in-postmenopausal-women

6. Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Substances. Federal Register, December 31, 2025. https://www.federalregister.gov/documents/2025/12/31/2025-24123/fourth-temporary-extension-of-covid-19-telemedicine-flexibilities-for-prescription-of-controlled

7. Drug Enforcement Administration, Diversion Control Division. Telemedicine: State Registration Q&A (EO-DEA192, DEA-DC-044). https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-044)(EO-DEA192)_Telemed_State_Reg_QA_(Final).pdf

8. Special Registrations for Telemedicine and Limited State Telemedicine Registrations. Federal Register, January 17, 2025. https://www.federalregister.gov/documents/2025/01/17/2025-01099/special-registrations-for-telemedicine-and-limited-state-telemedicine-registrations

9. DEA Prescribing of Controlled Substances via Telemedicine. Alliance for Connected Care. https://connectwithcare.org/dea-prescribing-of-controlled-substances/

10. Mahatole S, Ananthan P. US regulators urge more research on testosterone therapy for women. Reuters (via GV Wire), September 17, 2026. https://gvwire.com/2026/09/17/us-regulators-urge-more-research-on-testosterone-therapy-for-women/

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Vaginal Dryness After Menopause: Why It Doesn’t Go Away

On By Dr. Scott RennieIn Menopause & Women's HealthLeave a comment

Half the women who have it have never used a single treatment. Among the never-treated, close to three quarters have never mentioned it to a clinician. Both come from EMPOWER, a survey of 1,858 postmenopausal American women with genitourinary symptoms; most who stayed quiet assumed it was aging they had to live with (1).

That assumption is wrong in one specific way. Hot flashes usually fade. This does not.

Why the name changed in 2014

Genitourinary syndrome of menopause was coined at a 2013 ISSWSH and NAMS conference and endorsed by both boards in 2014 (2). It replaced vulvovaginal atrophy and atrophic vaginitis. Those terms implied an infection that is not there, and left out the urethra and bladder entirely (2).

Somewhere between 27% and 84%

That is the range cited by The Menopause Society and the 2025 AUA/SUFU/AUGS guideline (1)(3). A three-fold spread is less a number than a confession that case definitions vary wildly. One firmer figure: 84% of women six years past menopause had it (1).

Then the sentence that belongs on every package insert, verbatim from the 2020 position statement: “In contrast to vasomotor symptoms (VMS) that usually improve over time, GSM is generally progressive without effective therapy” (1). Generally, not always, but the direction is the point, and the 2025 guideline treats GSM as chronic (3). Untreated, it is also associated with women avoiding Pap smears (3). A complaint nobody raised becomes a screening gap.

What I can settle over video. What I can’t.

I practice entirely by telemedicine, so let me be direct about limits. The Menopause Society says diagnosis “requires the presence of both characteristic examination findings and bothersome symptoms” (1), and the 2025 guideline requires a genitourinary examination (3). No camera does that half.

Nearly everything else works remotely: the focused history, a medication review catching aromatase inhibitors and GnRH agonists, self-administered instruments like the Cervantes-GSM (3). And one free question: did the symptoms start before menopause? If so, another diagnosis is likelier (1). The mimics are the problem. Lichen sclerosus reads like GSM in a history and carries carcinoma risk. Postmenopausal bleeding I never close out on video. No guideline addresses telemedicine for GSM, so that division of labor is my own reasoning, not a society position.

So here is my position, and it diverges from the letter of the guideline. I recommend that a patient be examined in person for these symptoms. I also do not hesitate to treat her when what she describes is clearly GSM to me. The exam still needs to happen, and I say so. It does not have to happen first.

Red flags are where I hold the line. Bleeding after menopause, a visible lesion, or symptoms that predate menopause need eyes on them before anything else.

Start in the drugstore aisle

Lubricants and moisturizers get confused constantly. A lubricant goes on at the time of sex to cut friction. A moisturizer goes on a schedule, sex or no sex, to rehydrate tissue over time (1). Oil-based lubricants erode condoms. Hyaluronic acid sells at a premium with no evidence it beats products without it (1).

The humbling part. MsFLASH randomized 302 postmenopausal women to a 10-microgram vaginal estradiol tablet, a moisturizer, or dual placebo. At 12 weeks nothing beat placebo (P = .25 and .31) (4). The Menopause Society notes the placebo gel likely lubricated (1). The lesson survives: plenty improve on a drugstore moisturizer, which is why the guideline recommends them (3).

Low-dose vaginal estrogen

Most evidence, strongest recommendation (3). Vagifem (10 micrograms) and Imvexxy (4 or 10) run daily two weeks, then twice weekly; the Estring ring lasts 90 days; creams taper to two or three times weekly (1). After 14 days of daily use, serum estradiol on the inserts measured 3.6 and 4.6 pg/mL against 4.3 on placebo (1). Across 20 trials and 2,983 women exposed up to a year there was one endometrial cancer, and no progestogen is needed (1)(3).

The gap nobody advertises: the longest randomized trial of any vaginal estrogen ran 52 weeks (1), and this needs years of treatment. Reassurance past that is observational: 18 years of Nurses’ Health Study data found no excess chronic disease (5). Cochrane graded 30 trials low to moderate quality (6). Consistent direction, mediocre trials.

My own preference is the vaginal tablets. That is my preference and nothing stronger, and Cochrane found no efficacy difference between the preparations anyway (6). What decides it is what the patient prefers and what it costs her.

About that boxed warning, precisely

On November 10, 2025, FDA announced it was initiating removal of boxed warning language on menopausal hormone therapy, including low-dose vaginal estrogen, covering cardiovascular disease and breast cancer, plus probable dementia (7). The Menopause Society agreed, calling the warning a likely deterrent to a safe, effective therapy (8).

Implementation is running product by product. As of August 29, 2026, FDA’s updated-labeling list holds six drugs, and Estring is the only vaginal estrogen among them, its label updated April 27, 2026 (9)(10). Vagifem, Imvexxy and Premarin Vaginal Cream still carry the full boxed warning (11)(12)(13). Fill a prescription this week and you may find that warning in your own package. The paperwork has not caught up. Two things not to conflate: systemic estrogen-alone products keep a boxed warning for endometrial cancer, and ospemifene was never part of this action (7)(14).

DHEA, ospemifene, and the limits of systemic therapy

Vaginal DHEA (prasterone, Intrarosa) is a 6.5 mg insert used once daily, and endometrial sampling stayed inactive or atrophic in all 422 women studied for 52 weeks (1). It has never carried a boxed warning, and that predates the recent FDA action (15). Ospemifene (Osphena), the only oral option at 60 mg daily, holds the guideline’s weakest recommendation grade (3), causes hot flashes in 7.2% versus 2% on placebo (1), and its own boxed warning for endometrial cancer and cardiovascular disorders stands (14).

If you take systemic hormone therapy for hot flashes, do not assume it covers this. Some get inadequate GSM relief from it, and the guideline recommends adding local estrogen or DHEA (3). You will see percentages quoted for this. I could not trace one to a primary source, so I am not repeating one. The add-on rests on expert opinion, with no data on the combination’s risk (3).

Lasers

In a sham-controlled trial, 85 women were followed 12 months after three CO2 laser or sham treatments. Symptom severity fell 17.2 points with laser and 26.6 points with sham (16). Read that again. The point estimate favored sham, and the biopsy histology showed no difference either, so the collagen-remodeling mechanism they are sold on was never shown in tissue. The 2025 guideline calls them experimental outside trials (3), and no energy-based device is FDA-cleared for any gynecologic indication (17). Cash pay, expensive, and the widest gap between marketing and data here.

The best evidence here is about UTIs

Recurrent UTI means two culture-proven infections in six months, or three in a year (1). Vaginal estrogen for prevention is the only Grade B statement in the 2025 guideline; every other one is Grade C or expert opinion (3). Raz and Stamm, 1993: 93 postmenopausal women randomized to intravaginal estriol or placebo, infections falling to 0.5 episodes per patient-year against 5.9 (18). Estriol, oddly, is not sold as an FDA-approved product here (3), so the field’s cleanest result came from a drug Americans cannot prescribe. Pelvic floor physical therapy suits coexisting pelvic floor dysfunction, though its direct GSM evidence is one single-arm feasibility study (3).

After breast cancer, especially on an aromatase inhibitor

Aromatase inhibitors produce what the 2020 statement calls a profound estrogen-deficiency state, and severe GSM in most survivors (1). ACOG’s 2021 clinical consensus, which replaced its 2016 committee opinion: nonhormonal treatment first line; if that fails, low-dose vaginal estrogen may be used after breast cancer, including on tamoxifen, and in aromatase inhibitor users after shared decision-making between patient, gynecologist and oncologist (19). ACOG reviewed seven studies covering more than 4,000 survivors, median follow-up two to seven years, tamoxifen and aromatase inhibitor users alike, with no increased recurrence, and calls low-dose vaginal estrogen safe in women with hormone receptor-positive disease at low risk of recurrence (19).

The caution traces to one Danish cohort: 8,461 women with early ER-positive breast cancer, 1,957 of them vaginal estrogen users. Overall recurrence risk was not raised, relative risk 1.08 (95% CI 0.89 to 1.32); in the subgroup on adjuvant aromatase inhibitors it was 1.39 (95% CI 1.04 to 1.85), with no rise in mortality (20). The finding is contested; JNCI published four separate comments responding to it. It is an observational subgroup, and a 2024 meta-analysis of eight studies found no such increase (3). I will not tell you it is settled. Neither ACOG nor the urology panel did. Both put the oncologist in the room.

So who starts that conversation. She raises it with her oncologist, and I make sure that conversation starts from evidence rather than a package insert. ACOG puts that squarely on the prescriber: provide “data on the safety of low-dose vaginal estrogen to patients and their medical oncologists” (19). It matters because the warning FDA only began removing in November 2025 is still printed on three of the products named above, and an oncologist reading it has every reason to say no.

If you are the patient

Bring it up. That is the whole intervention, and most women never do. Say the words: dryness, burning, painful sex, urgency, recurring infections. Expect any prescription to work over weeks and to continue indefinitely.

Notes for clinicians

The screening question is the treatment. Asking costs thirty seconds. Two habits worth changing: stop ordering estradiol and FSH to diagnose this (3), and warn women about the boxed warning before the pharmacy does (1).

Here is mine, word for word.

“Do you experience vaginal dryness more now than you used to? Sometimes this can be a common side effect of menopause which can be related to painful intercourse.”

The Bottom Line

GSM reaches a quarter to four fifths of postmenopausal women and generally does not improve on its own. Half of affected women have never treated it, mostly because nobody asked. A drugstore moisturizer is a legitimate first step. Low-dose vaginal estrogen barely reaches the bloodstream and has 18 years of observational safety behind it, though most packages still carry a boxed warning FDA has already directed off. Lasers lost to sham. And a woman on an aromatase inhibitor deserves a real conversation with both her physicians, not a blanket no.

Related Reading

FDA Removes Black Box Warning From Menopause Hormone Therapy Perimenopause and Menopause Symptoms and How to Manage Them Menopause Treatment by Telemedicine: How It Works Vaginal Yeast Infections: Symptoms, Causes, Treatment Bacterial Vaginosis: Most Common Cause of Vaginal Discharge UTI (Bladder Infection): Common Questions Answered

Scott Rennie, D.O.
Board Certified in Obesity Medicine and Family Medicine

This blog is for educational purposes only and does not constitute individual medical advice. Always consult your own physician before making changes to your health, medications, or treatment plan.

Sources

1. Menopause Society 2020 GSM position statement. https://menopause.org/wp-content/uploads/default-document-library/2020-gsm-ps.pdf

2. Portman DJ, Gass ML. Maturitas. 2014;79(3):349-354. https://pubmed.ncbi.nlm.nih.gov/25179577/

3. AUA/SUFU/AUGS GSM guideline, 2025. https://www.auanet.org/guidelines-and-quality/guidelines/genitourinary-syndrome-of-menopause

4. Mitchell CM, et al. MsFLASH. JAMA Intern Med. 2018;178(5):681-690. https://pubmed.ncbi.nlm.nih.gov/29554173/

5. Bhupathiraju SN, et al. Menopause. 2019;26(6):603-610. https://pubmed.ncbi.nlm.nih.gov/30562320/

6. Lethaby A, et al. Cochrane Database Syst Rev. 2016;(8):CD001500. https://pubmed.ncbi.nlm.nih.gov/27577677/

7. FDA labeling change request, 11/10/2025. https://www.fda.gov/drugs/drug-alerts-and-statements/fda-requests-labeling-changes-related-safety-information-clarify-benefitrisk-considerations

8. Menopause Society comment on the FDA announcement. https://menopause.org/press-releases/the-menopause-society-comments-on-the-fda-announcement-on-hormone-therapy

9. FDA list of MHT products with updated prescribing information. https://www.fda.gov/drugs/drug-safety-and-availability/menopausal-hormone-therapies-updated-prescribing-information

10. DailyMed, ESTRING label, Apr 27, 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=110b9865-5a07-4d45-b560-e89947f12600

11. DailyMed, VAGIFEM label, Feb 12, 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e5ad3cf6-dd96-4e64-af21-c1eee38d0b88

12. DailyMed, IMVEXXY label, Sep 18, 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=104be9f2-a8f6-430e-9e01-2ee7cc1861f1

13. DailyMed, PREMARIN VAGINAL CREAM label, Jun 02, 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=96609623-528e-4aba-cabe-7254aed816d5

14. DailyMed, OSPHENA label, Feb 17, 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9accbcc9-78ee-4f84-9b7e-704f2ab1c413

15. DailyMed, INTRAROSA label, Aug 03, 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ada639d4-bac0-2ad0-e053-2a95a90afce7

16. Li FG, et al. JAMA. 2021;326(14):1381-1389. https://pmc.ncbi.nlm.nih.gov/articles/PMC8511979/

17. FDA CDRH letter to Inmode MD Ltd., July 24, 2018. https://www.fda.gov/files/medical%20devices/published/Inmode%20MD%20Lotd%20IHCTOA%20Letter.pdf

18. Raz R, Stamm WE. N Engl J Med. 1993;329(11):753-756. https://pubmed.ncbi.nlm.nih.gov/8350884/

19. ACOG Clinical Consensus Number 2, December 2021, “Treatment of Urogenital Symptoms in Individuals With a History of Estrogen-dependent Breast Cancer” (replaces Committee Opinion 659, March 2016). https://www.acog.org/clinical/clinical-guidance/clinical-consensus/articles/2021/12/treatment-of-urogenital-symptoms-in-individuals-with-a-history-of-estrogen-dependent-breast-cancer

20. Cold S, et al. J Natl Cancer Inst. 2022;114(10):1347-1354. https://pubmed.ncbi.nlm.nih.gov/35854422/

A wooden table in warm morning light with a coiled cloth tape measure, a small hand weight and a folded linen cloth

Does Menopause Cause Weight Gain, or Is It Just Aging?

On By Dr. Scott RennieIn Menopause & Women's Health, Weight Loss & Metabolic HealthLeave a comment

Your weight has been climbing about a pound a year since your early forties. Then something else changed. Same body, rearranged. The jeans that caught at the hip now catch at the waist.

Aging put the weight on. Menopause moved it.

The scale was never the menopause story

The Study of Women’s Health Across the Nation tracked women through the transition with repeated DXA scans. Weight and BMI gains that begin in premenopause “continue on an unaltered trajectory” through it, then flatten after the final period (1). Menopause does not bend the weight curve. The curve was already bending.

Two SWAN numbers circulate and both are real. In the full cohort of 3,064 women aged 42 to 52, weight rose 2.1 kg over three years, about 0.7 kg a year (2). In the smaller DXA sub-cohort, inside the 3.5-year window around the final period, 0.25 kg a year (1). Call it a pound to a pound and a half a year through midlife, none of it accelerated by menopause.

Where the fat goes

In 380 SWAN women with serial DXA, visceral fat drifted down before the transition at 1.85% a year, then climbed 6.24% a year inside the transition window (95% CI 4.31 to 8.17), settling at 1.47% after (3). Android fat went from 1.21% to 5.54%; the hip and thigh depot only to 2.03%. Lean mass flips sign in the same window, from gaining 0.2% a year to losing 0.2% (1), on top of the 3% to 8% per decade women lose after 30 (4).

Waist girth, meanwhile, rises 0.55% a year before the transition and 0.96% during it (3). Visceral fat moves six times faster than the tape can see, which is why a stable BMI and an unchanged waist are not reassurance.

Your metabolism did not crash at 50

Doubly labeled water, the reference method for what a human actually burns, was applied to 6,421 people across 29 countries. Total expenditure, basal expenditure and fat-free mass were “all stable from age 20 to 60” (5). The break point for adjusted total expenditure sits at 63.0 years, and the decline after it runs 0.7% a year (5).

The estradiol-specific effect is real and modest. Forty-five premenopausal women were randomized to ovarian suppression with placebo or transdermal estradiol add-back. Resting expenditure fell 54 kcal a day on placebo and did not fall at all with estradiol (6). Fifty-four calories. Measurable. Not a collapse.

Why it happens, and how much of that is known

Less than the confidence of the explanations would suggest. Estradiol loss lowers resting expenditure, since add-back prevented it in a randomized design (6), and the redistribution is time-locked to the final period rather than to birthdays (3). Past that it thins out fast. The one randomized ovarian-suppression trial measuring body composition and free-living expenditure together, 34 women over 24 weeks, found no endpoint that differed between groups (7). The Menopause Society says estrogen regulation of energy intake and expenditure “has not been well studied,” with “a paucity of studies” on estrogen and skeletal muscle (8). Falling estradiol, rising FSH, the androgen-to-estrogen shift: nobody has sorted out which drives it.

What shows up on your labs

SWAN modeled cardiovascular risk factors two ways in 1,054 women with a natural final period, once as chronological aging and once as ovarian aging. Only total cholesterol, LDL cholesterol and apolipoprotein B jumped inside the year before and after the final period (9). Glucose, insulin, blood pressure, fibrinogen and CRP fit the plain aging model (9), and the American Heart Association agrees (10).

So insulin resistance is not independently menopause-driven, whatever you have been told. The visceral fat is menopause-linked, and visceral fat drives insulin resistance on its own. A chain, not a shortcut, and it points at different treatment.

Here is where my own practice diverges from the cohort data. I screen lipids and apoB at intake, before starting any medication for weight loss, so my trigger is the visit rather than the menopausal stage. For hormone therapy I don’t routinely order them. I give the patient the options and tell her up front that insurance sometimes will not pay for apoB or apoA testing, which turns out to be a real constraint on what actually gets drawn.

Lift something heavy, then eat enough protein to use it

101 randomized trials, 5,697 postmenopausal women. Training raised fat-free mass 0.66 kg and cut fat mass 1.27 kg, and the modalities split: resistance work won for lean mass (+0.90 kg), aerobic for fat and waist (1.94 kg, 2.30 cm) (11).

Protein partners that work rather than replacing it. In 776 postmenopausal women aged 55 and older, whey improved lower-limb lean mass and strength when paired with resistance training, and had “no significant benefit on muscle strength or lean mass” without it (12). The powder is not the intervention.

Write down 1.2 g of protein per kilogram daily, 150 minutes of moderate activity weekly, strength training twice a week (4). On an incretin, higher: 1.2 to 1.6 g/kg/d, strength work three times weekly (13).

The strongest diet trial here is a prevention trial

The Women’s Healthy Lifestyle Project randomized 535 premenopausal women, mean age 47, and followed them 54 months through the transition. The intervention group finished 0.2 lb lighter. Controls gained 5.2 lb (14). Which diet matters less: 144 centrally obese postmenopausal women randomized to an energy-restricted Mediterranean or Central European diet both lost 7.6 kg and 24.6% of visceral fat in 16 weeks, with no difference between arms (15). Choose the one you will still be doing next year.

Hormone therapy, stated precisely in both directions

A Cochrane review of 28 randomized trials and 28,559 women found no evidence that estrogen alone or estrogen with progestogen affects body weight or prevents the BMI increase normally experienced at menopause (16). That review is old, last published in 2000, and still the largest pooled analysis of that endpoint. Hormone therapy does not cause weight loss, and it does not prevent menopausal weight gain.

What it does is narrower. The Menopause Society’s own key point: hormone therapy “may help attenuate abdominal adipose accumulation and weight gain associated with the menopause transition,” and “the effect is small” (8). In the WHI, no significant slowing of weight gain and a lesser waist increase over three years (8). On muscle, systematic reviews find neither benefit nor harm (8). A 2026 review is blunt: hormone therapy “should not be marketed or prescribed for weight loss or obesity treatment” (17).

Good drug. Vasomotor symptoms, genitourinary syndrome, bone. Abdominal fat is not on that list.

My own practice, stated plainly: I don’t prescribe MHT for patients who want to lose abdominal fat.

GLP-1s and the muscle question

Menopausal status does not blunt these drugs. A post hoc SURMOUNT analysis by reproductive stage found tirzepatide produced 23% weight reduction in postmenopausal women against 3% on placebo, matching premenopausal women at 26% versus 2% (18).

Now the counterintuitive part. In the SURMOUNT-1 DXA substudy, 160 participants scanned at baseline and week 72, tirzepatide produced 21.3% weight loss, 33.9% fat mass loss and 10.9% lean mass loss (19). Of the weight lost, roughly 75% was fat and 25% lean in both the tirzepatide and the placebo arms (19). The lean loss scales with the weight lost rather than with the drug.

DXA lean mass is also not muscle. It counts water, glycogen and organ mass, and modeling puts true muscle loss nearer 10% to 15% of weight reduction in women who are not strength training (13). In a 106-patient semaglutide cohort, grip strength rose 4.1 kg at a year and sarcopenic obesity fell from 49% to 33% (20). Function can improve while the DXA number falls.

Still, nobody has published incident sarcopenia or functional outcomes for postmenopausal women on these drugs. That gap is why protein and lifting belong in the prescription.

When I start a postmenopausal patient on an incretin, the instruction is 1.6 g of protein per kilogram of body weight a day, and strength training two to three times a week. That is the top of the range the evidence supports (13), and I put it there on purpose.

What is oversold

Supplements sold for menopausal weight loss. I looked for a randomized trial of any of them showing meaningful weight or visceral fat reduction and found none. Absence of evidence in one search is not proof of absence, so put it precisely: the marketing category exists; the trial literature does not. The Menopause Society does not recommend supplements or herbal remedies even for hot flashes (21).

Hormone therapy stacked on a GLP-1. Two retrospective cohorts, no randomized trial, and the 2026 review is unambiguous: do not start hormone therapy to boost an obesity medication (17).

And one asymmetry worth getting exactly right. Treating hot flashes or insomnia in order to lose weight has no trial behind it that I can find. The reverse direction is supported: the Menopause Society recommends weight loss for vasomotor symptoms, conceding those studies are small pilots and post hoc analyses (21).

If you are the patient reading this

Stop asking whether menopause made you gain weight. Ask where it went. Your BMI can sit still while visceral fat climbs 6% a year (3), so get lipids and apoB checked around your final period (9). Then put your effort where the randomized evidence is: resistance training, and a deficit you can hold for years.

Which raises the obvious question for a practice that runs entirely over video. So here is what I actually do. Patients get a Withings scale that syncs into the chart on its own and reports weight, BMI and body fat. A blood pressure cuff syncs the same way, automatically. The waist they measure themselves, with a tape, because the scale will not catch what the tape catches. Weight and blood pressure come in at least monthly and often more frequently than that, which means the trend is visible long before an annual visit would have found it.

For the clinicians

Screening beats explaining. The window runs roughly two years before to 18 months after the final period (1), and that is when lipids move and visceral fat accelerates (3)(9). Order the panel with apoB in it, and do not reassure a woman on a stable BMI or an unchanged waist; both understate a 6.24% per year visceral gain (3). When you start an incretin, write the protein target and the strength training into the plan (13). Hormone therapy earns its place on symptoms, bone and the diabetes signal (8), and no line at all on the weight plan.

The Bottom Line

Aging adds the weight, roughly a pound and a half a year through midlife, on a curve menopause does not bend (1)(2). Menopause moves the fat, visceral gain going from minus 1.85% to plus 6.24% a year inside a 3.5-year window (3). Metabolism holds steady to 60 (5). Hormone therapy treats symptoms and bone, not weight (8)(16). What changes the outcome is lifting, protein, a deficit you can sustain, and where indicated, a medication that works as well after menopause as before (11)(18).

Related Reading

Perimenopause and Menopause Symptoms and How to Manage Them FDA Removes Black Box Warning From Menopause Hormone Therapy Why Menopause Care Is Missing From Women’s Checkups Does Fasting Slow Aging? What the Science Says How Does Aging Change Your Metabolism? What Research Shows Why Exercise Matters for Obesity Beyond Weight Loss How Obesity in Pregnancy Affects the Baby and Placenta Why Is Losing Weight and Keeping It Off So Hard?

Scott Rennie, D.O.
Board Certified in Obesity Medicine and Family Medicine

This blog is for educational purposes only and does not constitute individual medical advice. Always consult your own physician before making changes to your health, medications, or treatment plan.

Sources

1. Greendale GA, et al. Changes in body composition and weight during the menopause transition. JCI Insight 2019. https://pmc.ncbi.nlm.nih.gov/articles/PMC6483504/

2. Sternfeld B, et al. Physical activity and changes in weight and waist circumference in midlife women. Am J Epidemiol 2004. https://academic.oup.com/aje/article/160/9/912/86561

3. Greendale GA, et al. Changes in regional fat distribution and anthropometric measures. J Clin Endocrinol Metab 2021. https://pmc.ncbi.nlm.nih.gov/articles/PMC8372653/

4. The Menopause Society. MenoNote: Midlife Weight Gain, 2025. https://menopause.org/wp-content/uploads/for-women/MenoNote-Weight-Gain.pdf

5. Pontzer H, et al. Daily energy expenditure through the human life course. Science 2021. https://doi.org/10.1126/science.abe5017

6. Melanson EL, et al. Regulation of energy expenditure by estradiol in premenopausal women. J Appl Physiol 2015. https://pmc.ncbi.nlm.nih.gov/articles/PMC4628992/

7. Gavin KM, et al. Ovarian suppression in premenopausal women: no change in free-living energy expenditure. Obesity 2020. https://pmc.ncbi.nlm.nih.gov/articles/PMC7653843/

8. North American Menopause Society. 2022 hormone therapy position statement. Menopause 2022. https://menopause.org/wp-content/uploads/professional/nams-2022-hormone-therapy-position-statement.pdf

9. Matthews KA, et al. Chronological aging or the menopausal transition? J Am Coll Cardiol 2009. https://doi.org/10.1016/j.jacc.2009.10.009

10. El Khoudary SR, et al. Menopause transition and cardiovascular disease risk. Circulation 2020. https://doi.org/10.1161/CIR.0000000000000912

11. Khalafi M, et al. Exercise training and body composition in postmenopausal women. Front Endocrinol 2023. https://pmc.ncbi.nlm.nih.gov/articles/PMC10306117/

12. Kuo YY, et al. Whey protein supplementation in postmenopausal women. Nutrients 2022. https://pmc.ncbi.nlm.nih.gov/articles/PMC9572824/

13. Mozaffarian D, et al. Nutritional priorities to support GLP-1 therapy for obesity. Am J Clin Nutr 2025. https://pmc.ncbi.nlm.nih.gov/articles/PMC12612741/

14. Kuller LH, et al. Women’s Healthy Lifestyle Project: results at 54 months. Circulation 2001. https://doi.org/10.1161/01.cir.103.1.32

15. Bajerska J, et al. Energy-restricted Mediterranean and Central-European diets in postmenopausal women. Sci Rep 2018. https://pmc.ncbi.nlm.nih.gov/articles/PMC6057942/

16. Kongnyuy EJ, et al. Hormone replacement therapy: weight and body fat distribution. Cochrane Database Syst Rev CD001018. https://www.cochrane.org/evidence/CD001018_hormone-replacement-therapy-has-no-effect-body-weight-and-cannot-prevent-weight-gain-menopause

17. Younglove C. Menopause hormone therapy in weight management. Obesity Pillars 2026. https://pmc.ncbi.nlm.nih.gov/articles/PMC13010941/

18. Tchang BG, et al. Weight reduction with tirzepatide by reproductive stage: SURMOUNT post hoc analysis. Obesity 2025. https://doi.org/10.1002/oby.24254

19. Look M, et al. Body composition changes with tirzepatide in SURMOUNT-1. Diabetes Obes Metab 2025. https://doi.org/10.1111/dom.16275

20. Alissou M, et al. Semaglutide, fat mass, lean mass and muscle function: SEMALEAN. Diabetes Obes Metab 2026. https://pmc.ncbi.nlm.nih.gov/articles/PMC12673431/

21. North American Menopause Society. 2023 nonhormone therapy position statement. Menopause 2023. https://menopause.org/wp-content/uploads/professional/2023-nonhormone-therapy-position-statement.pdf

A flat black rectangle lying on cream linen surrounded by sprigs of dried sage, lit by soft window light.

FDA Removes Black Box Warning From Menopause Hormone Therapy

On By Dr. Scott RennieIn Menopause & Women's HealthLeave a comment

Since the headlines ran, some version of the same question has been opening my video visits. “So it’s safe now, right? I saw it on the news.”

The women asking are usually a few years past their last period, sleeping badly, foggy at work, and frustrated. Somewhere along the way they were told hormones would give them breast cancer, and that was the end of the conversation. Something did change this summer. What changed is not what most people think.

The FDA did not run a new trial. No fresh outcome data landed on anyone’s desk. What happened is better described as a labeling correction: a regulatory acknowledgment that a warning written for one population had been applied, for more than twenty years, to a completely different one. That distinction is the whole story. It tells you how much permission this gives us, and it tells you exactly where the permission stops.

What Actually Happened

On November 10, 2025, HHS and the FDA announced they were initiating removal of the boxed warning from menopausal hormone therapy products containing estrogen. The specific language coming out covered cardiovascular disease, breast cancer, and probable dementia. (1) The move followed a public expert panel the agency convened in July 2025 and a comment period after that.

Then came the slower part, the part that got almost no coverage. Removing a boxed warning is not a press release. It is a product-by-product labeling supplement for every manufacturer. In February 2026, the FDA approved the first batch: labeling changes for six products spanning all four categories of menopausal hormone therapy, including systemic combination therapy, systemic estrogen alone, systemic progestogen for women with a uterus, and topical vaginal estrogen. (2) Twenty-nine companies had submitted proposed changes by that point. (2) More have been approved since.

The new labels also add something that wasn’t there before: age-specific framing, pointing toward initiation within ten years of menopause onset or before age 60 for systemic therapy. (2)

So the headline “HRT is safe now” is doing a lot of work it can’t support. The accurate version is that a warning which never fit a healthy 52-year-old with hot flashes has finally been taken off her prescription.

Why That Warning Was There In The First Place

You cannot understand the correction without understanding the error.

In July 2002, the Women’s Health Initiative stopped its estrogen plus progestin arm early. That trial had randomized 16,608 postmenopausal women with an intact uterus to conjugated equine estrogens plus medroxyprogesterone acetate or placebo. (3) The data safety monitoring board pulled the plug at 5.2 years because the global index crossed a predetermined boundary.

The relative risks made every front page in the country. Invasive breast cancer, hazard ratio 1.26. Coronary heart disease, 1.29. Stroke, 1.41. Pulmonary embolism, 2.13. (3)

What ran in far smaller type, if it ran at all, were the absolute numbers. Per 10,000 women per year of treatment: seven more coronary events, eight more strokes, eight more pulmonary emboli, eight more invasive breast cancers. Also five fewer hip fractures and six fewer colorectal cancers. (3) These are small absolute differences. “A twenty-six percent increase in breast cancer” and “eight additional cases per ten thousand women per year” describe the same finding, and only one of them ended a generation of treatment.

The estrogen-alone arm, which enrolled 10,739 women who had already had a hysterectomy, was stopped separately in 2004. That arm never showed an increase in breast cancer at all. If anything it trended the other direction. (4) The boxed warning went on both.

The dementia language came from WHIMS, the memory substudy. WHIMS enrolled women aged 65 to 79. (5) That is worth reading twice. A finding generated exclusively in women 65 and older became a printed warning handed to women in their early fifties for the next two decades.

The Trial Didn’t Study The Women Who Got The Warning

Mean age at enrollment in WHI was 63.3 years. (3)

Think about who that is. The average American woman reaches menopause around 51. A 63-year-old enrolling in the mid-1990s was, on average, more than a decade out from her final period. Many were two decades out. Most were not symptomatic, which was by design, because WHI was built as a chronic disease prevention trial and not a symptom trial. Participants were also carrying the cardiovascular risk you would expect at that age, including a substantial proportion with hypertension, obesity, and subclinical atherosclerosis nobody had imaged.

Put estrogen into an artery that already has established, possibly unstable plaque and you are not doing the same thing you do when you put estrogen into a 52-year-old’s relatively clean vasculature. That is the biological core of what became known as the timing hypothesis: estrogen appears to be protective, or at least neutral, in healthy endothelium, and potentially destabilizing in diseased endothelium.

The evidence for it isn’t a hunch.

The ELITE trial randomized 643 postmenopausal women to oral estradiol or placebo, stratified by how far out from menopause they were. In women less than six years postmenopause, estradiol significantly slowed carotid intima-media thickness progression. In women ten or more years out, it did nothing. (6) Same drug, same trial, opposite vascular story depending on when you started it.

The Danish Osteoporosis Prevention Study randomized about 1,000 recently postmenopausal women to hormone therapy or no treatment and followed them for ten years. The treated group had a lower composite rate of death, heart failure hospitalization, and myocardial infarction, with no increase in cancer, stroke, or venous thromboembolism. (7) It was open-label, which limits it, and it wasn’t powered as a cardiovascular outcomes trial. But it points the same direction.

And WHI’s own investigators, when they went back and stratified by age, found the pattern sitting in their own data. Women who started in their fifties looked different from women who started in their seventies. (8) The 18-year follow-up of both WHI arms, published in 2017, found no increase in all-cause mortality, cardiovascular mortality, or cancer mortality in either treatment group. (9)

None of this is new. ELITE published in 2016. The mortality follow-up published in 2017. The FDA’s 2025 action was a review of literature that already existed, which is exactly why calling it a labeling correction is fair. The evidence got there long before the label did.

Now The Part Nobody Is Covering: What This Does Not Do

Here is where I want to slow down, because the celebratory version of this story is going to get people hurt.

The endometrial cancer warning did not go away

The FDA explicitly did not seek removal of the boxed warning regarding endometrial cancer for systemic estrogen-alone products. (1) Unopposed systemic estrogen in a woman with a uterus causes endometrial hyperplasia and carcinoma, and the PEPI trial put hard numbers on how fast. Over three years on unopposed conjugated estrogen, 22.7 percent of women developed complex hyperplasia and 11.8 percent developed atypical hyperplasia. Every arm that included a progestogen held hyperplasia under 1 percent. (14) That risk is dose and duration dependent, it is real, and it is almost entirely preventable. Nothing in this label change touched it.

The word doing all the work in that paragraph is systemic, and it is worth slowing down on, because this is the single most muddled point in the entire subject.

Low-dose vaginal estrogen does not need a progestogen. Not for the cream, not for the ring, not for the tablet. A systematic review of 20 randomized trials covering nearly 3,000 women found endometrial cancer in 0.03 percent and hyperplasia in 0.4 percent, which is background noise, and the WHI Observational Study found no association either. (15) The Menopause Society does not recommend adding a progestogen to low-dose vaginal estrogen therapy. Neither do I. If you have a patient on Estring or a small twice-weekly dab of vaginal estradiol cream for dryness and recurrent UTIs, she does not need progesterone, and putting her on it adds side effects for no endometrial benefit.

Here is the part that trips people up. The dividing line is not oral versus topical. It is systemic versus local. A patch, a pump gel, a spray, and a compounded body cream are all systemic estrogen, and they all raise endometrial risk the same way a pill does. Transdermal delivery changes the clot risk, which I will get to in a minute. It does nothing for the endometrium. If she has a uterus and the estrogen is reaching her bloodstream at systemic levels, she needs a progestogen at an adequate dose for as long as she is on it, no matter what the delivery device looks like.

I bring it up because the compounded and direct-to-consumer market blurs exactly that line, and “cream” gets used to mean two completely different products. I have picked up patients well into a compounded systemic estradiol cream, rubbed on the inner arm at a real systemic dose, with no progestogen prescribed and nobody having mentioned that they needed one.

Removing a warning does not remove a risk

Venous thromboembolism with oral estrogen is the cleanest example. The large UK nested case-control analysis of more than 80,000 VTE cases found oral hormone therapy carried an adjusted odds ratio of 1.58 overall, with oral conjugated equine estrogen plus medroxyprogesterone acetate at 2.10. Transdermal preparations showed no increased risk. Head to head, oral was associated with roughly 70 percent higher VTE risk than transdermal. (10)

That finding should change your prescription pad, not your enthusiasm. The route matters here, and this is the one place it does. First-pass hepatic metabolism drives the procoagulant shift, and transdermal estradiol bypasses it. For a woman with obesity, a prior clot, a thrombophilia, migraine with aura, or a family history that makes you uneasy, transdermal isn’t a preference. It’s the answer.

Breast cancer risk was overstated, not erased

The 2019 Lancet collaborative reanalysis of the worldwide epidemiological evidence put it in numbers a patient can actually hold onto. For a woman of average weight starting at age 50 and using therapy for five years, the excess breast cancer incidence through age 69 is roughly one additional case per 50 users of estrogen plus daily progestogen, and about one per 200 users of estrogen alone. (11) Small. Not zero. And dose and duration dependent, which means the conversation at year eight is a different conversation than the one at year two.

For context I give patients, because context is what they are usually missing: that magnitude sits in the same neighborhood as two alcoholic drinks a day, or carrying significant excess weight after menopause. Nobody puts a black box on either of those.

This is still not a primary prevention drug

The approved indications didn’t change. Systemic hormone therapy is indicated for moderate to severe vasomotor symptoms, for moderate to severe genitourinary symptoms of menopause, for prevention of postmenopausal osteoporosis in appropriate candidates, and for hypoestrogenism from hypogonadism or primary ovarian insufficiency. That’s the list.

The USPSTF continues to recommend against menopausal hormone therapy for the primary prevention of chronic conditions, a grade D recommendation. (12) You do not start a 58-year-old on estradiol to prevent her heart attack. If the timing hypothesis eventually earns a prevention indication, it will do so through a trial designed to answer that question, and that trial has not been run.

A boxed warning coming off is not new evidence coming in

There were no new randomized trials behind the November 2025 action. The FDA reviewed what already existed and concluded the label misrepresented it. That is a real and overdue fix. It is not a discovery, and anyone selling it to you as one is probably selling you something else too.

If You’re A Patient: You Can Reopen This

If you were told no in 2009, or 2015, or honestly even in 2023, the answer you got was shaped by a warning that has since been withdrawn. You are allowed to ask again.

A few things worth knowing before that appointment.

The window matters. The risk-benefit math is most favorable for women who are generally healthy, under 60, and within about ten years of their final menstrual period. The further out from that window you are, the more carefully the decision has to be individualized, and for some women the answer will still be no.

Vaginal estrogen is a separate conversation entirely. Low-dose vaginal estrogen for genitourinary symptoms, meaning dryness, painful sex, recurrent urinary tract infections, urgency, has minimal systemic absorption. The Menopause Society specifically welcomed the boxed warning removal for these products, describing them as safe and effective for a condition that affects most menopausal women. (13) If vaginal symptoms are your issue, the systemic risk conversation largely doesn’t apply to you, and you almost certainly do not need to take progesterone alongside it.

There are still real contraindications. A history of breast cancer, an estrogen-dependent tumor, prior stroke or heart attack, active or prior venous thromboembolism, a known thrombophilia, significant liver disease, or unexplained vaginal bleeding that hasn’t been worked up. If any of those apply to you, the answer may genuinely be no, and there are non-hormonal options worth discussing, including the newer neurokinin receptor antagonists for hot flashes.

And bring specifics, even to a twenty minute video visit. How many nights a week you wake up. Whether you have stopped exercising. Whether sex hurts. Whether you are thinking about leaving a job you used to like. A recent blood pressure reading, when your last mammogram was, and what your mother’s and sister’s history looks like. Symptom burden is half the equation, and “I’m having some hot flashes” badly undersells what is usually going on.

If You’re A Colleague: How I’m Counseling Now

I practice entirely by telemedicine, so everything below happens over video, usually in one visit and a follow-up. Here is how I run it in 2026.

I start by asking what she was told before, and by whom. Roughly half of my perimenopausal and postmenopausal patients are carrying a specific prior refusal, and if I don’t surface it, it sits there and quietly undermines everything I say next.

Then I frame the decision around three questions instead of one. Is she in the window? What is her baseline cardiovascular and thrombotic risk? And what is her symptom burden, honestly measured? A woman at 52 with severe vasomotor symptoms and no risk factors is a different patient than a woman at 64 with controlled hypertension and mild night sweats. The label change does not collapse that difference.

The remote setting changes the logistics of that second question, not the standard. Before I start systemic therapy I want a blood pressure I trust, which usually means a home cuff and a few readings rather than one number she remembers from a year ago. I want her mammogram status current, her personal and family history of clot and breast cancer taken carefully rather than checkbox-style, and any abnormal bleeding evaluated in person before we go anywhere near estrogen. None of that requires me to be in the room. All of it requires me to actually ask.

Route selection is where I have gotten more opinionated. Transdermal estradiol is my default for anyone with obesity, hypertriglyceridemia, migraine with aura, gallbladder disease, or any thrombotic history, personal or family. (10) The oral versus transdermal difference in VTE risk is one of the few places in this entire discussion where we can meaningfully reduce absolute harm by changing one line on the prescription.

Progestogen goes with every uterus on systemic estrogen, and only with systemic estrogen. Micronized progesterone is my preference for the metabolic profile and possibly the breast profile, though I will say plainly that the comparative data across progestogens is observational and not as strong as some of the marketing suggests. If she is on vaginal estrogen alone, she does not get a progestogen from me.

I still ask about duration out loud, every year. Not because there is a hard stop at five years, because there isn’t one, and the old “lowest dose for the shortest duration” language has aged badly. But breast cancer risk is duration dependent (11), and the woman who has been on therapy for nine years should be making that choice consciously rather than by inertia.

And I document the shared decision making. Symptom burden, risk factors reviewed, route and rationale, progestogen plan, alternatives discussed. That note protected me before the label change and it protects me now.

One more thing, and it matters more in this setting than any other. The current news cycle is producing a wave of patients who want hormones for reasons that are not on the label. Longevity. Body composition. Cognitive performance. Telemedicine is where most of that demand is landing, and a lot of it is landing on platforms that will ship estradiol after a four-question intake form and never once ask about the uterus. I would much rather have the honest conversation about what the evidence does and does not support than have someone go around me to get a worse version of the same drug.

The Bottom Line

A warning that should never have been applied to a healthy 52-year-old with hot flashes has been removed. That is a genuine correction, and the women who were denied treatment for twenty years deserved it a long time ago.

What did not happen is a change in the underlying biology. Oral estrogen still raises clot risk. Unopposed systemic estrogen still endangers the endometrium, whatever it is delivered in. Breast cancer risk is still small, still real, still duration dependent. Hormone therapy still isn’t a preventive medication.

The label was wrong. The nuance was always right. We just get to have the conversation now without a black box sitting in the middle of the table.

Related Reading

Perimenopause and Menopause Symptoms and How to Manage Them Menopause Treatment by Telemedicine: How It Works Osteoporosis: How to Prevent It and How It’s Treated Mammograms: When to Get One and What to Expect Why Does High Cholesterol Matter? A Doctor Explains Vaginal Dryness After Menopause: Why It Doesn’t Go Away Does Menopause Cause Weight Gain, or Is It Just Aging?

Scott Rennie, D.O.
Board Certified in Obesity Medicine and Family Medicine

This blog is for educational purposes only and does not constitute individual medical advice. Always consult your own physician before making changes to your health, medications, or treatment plan.

Sources:

  1. U.S. Food and Drug Administration. HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy. November 10, 2025. https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy
  2. U.S. Food and Drug Administration. FDA Approves Labeling Changes to Menopausal Hormone Therapy Products. February 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-labeling-changes-menopausal-hormone-therapy-products
  3. Rossouw JE, et al. Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women: Principal Results From the Women’s Health Initiative Randomized Controlled Trial. JAMA. 2002;288(3):321-333. https://pubmed.ncbi.nlm.nih.gov/12117397/
  4. Anderson GL, et al. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women’s Health Initiative randomized controlled trial. JAMA. 2004;291(14):1701-1712. https://pubmed.ncbi.nlm.nih.gov/15082697/
  5. Shumaker SA, et al. Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women: the Women’s Health Initiative Memory Study. JAMA. 2003;289(20):2651-2662. https://pubmed.ncbi.nlm.nih.gov/12771112/
  6. Hodis HN, et al. Vascular Effects of Early versus Late Postmenopausal Treatment with Estradiol. N Engl J Med. 2016;374(13):1221-1231. https://www.nejm.org/doi/full/10.1056/NEJMoa1505241
  7. Schierbeck LL, et al. Effect of hormone replacement therapy on cardiovascular events in recently postmenopausal women: randomised trial. BMJ. 2012;345:e6409. https://www.bmj.com/content/345/bmj.e6409
  8. Manson JE, et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women’s Health Initiative randomized trials. JAMA. 2013;310(13):1353-1368. https://pubmed.ncbi.nlm.nih.gov/24084921/
  9. Manson JE, et al. Menopausal Hormone Therapy and Long-term All-Cause and Cause-Specific Mortality: The Women’s Health Initiative Randomized Trials. JAMA. 2017;318(10):927-938. https://pubmed.ncbi.nlm.nih.gov/28898378/
  10. Vinogradova Y, Coupland C, Hippisley-Cox J. Use of hormone replacement therapy and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases. BMJ. 2019;364:k4810. https://pubmed.ncbi.nlm.nih.gov/30626577/
  11. Collaborative Group on Hormonal Factors in Breast Cancer. Type and timing of menopausal hormone therapy and breast cancer risk: individual participant meta-analysis of the worldwide epidemiological evidence. Lancet. 2019;394(10204):1159-1168. https://pubmed.ncbi.nlm.nih.gov/31474332/
  12. US Preventive Services Task Force. Hormone Therapy for the Primary Prevention of Chronic Conditions in Postmenopausal Persons: USPSTF Recommendation Statement. JAMA. 2022;328(17):1740-1746. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/menopausal-hormone-therapy-preventive-medication
  13. The Menopause Society. The Menopause Society Comments on the FDA Announcement on Hormone Therapy. November 2025. https://menopause.org/press-releases/the-menopause-society-comments-on-the-fda-announcement-on-hormone-therapy
  14. The Writing Group for the PEPI Trial. Effects of hormone replacement therapy on endometrial histology in postmenopausal women: the Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. JAMA. 1996;275(5):370-375. https://pubmed.ncbi.nlm.nih.gov/8569016/
  15. Constantine GD, et al. Endometrial safety of low-dose vaginal estrogens in menopausal women: a systematic evidence review. Menopause. 2019;26(7):800-807. https://journals.lww.com/menopausejournal/fulltext/2019/07000/endometrial_safety_of_low_dose_vaginal_estrogens.18.aspx
A laptop open on a desk beside a bright window, with a glass carafe of water and a small plant

Menopause Care by Telemedicine: What a Virtual Visit Can and Cannot Do

On By Dr. Scott RennieIn Menopause & Women's HealthLeave a comment

You are 51. You have not had a period in fourteen months, you are waking at three in the morning soaked through your shirt, and the first opening with a gynecologist near you is in March. That gap is most of the reason virtual menopause care exists.

The question comes up in the first couple of minutes of a lot of my video visits. Can this actually be done over a screen? Fair question, and the answer is mostly yes, with one category of exception that matters more than everything else on this page combined.

The diagnosis is a conversation, not a lab draw

If you are 45 or older, your periods have stopped or gone erratic, and you are having hot flashes and night sweats, the diagnosis is clinical. No blood test required. For women in that age group with typical symptoms, routine hormone testing is not recommended, and that is not a corner being cut for the sake of convenience (1).

Patients ask me to check their hormone levels constantly. Almost always they have read something first and done real work on their own, and what they are after is a number that explains why they feel the way they do.

I understand that request better than I used to. It is not really about the lab. It is about wanting proof that this is happening and that she is not imagining it.

Which is exactly why ordering it can backfire. FSH swings week to week in perimenopause, so a single value lands wherever it happens to land that morning. Hand a woman a normal result while she is exhausted and soaked at four in the morning, and you have taken away the validation she came for and given her nothing in exchange. So I tell her what the test can and cannot settle, and then I treat the symptoms, which is what she needed either way.

Under 45 is a different conversation. Early menopause and primary ovarian insufficiency change the stakes, and there I do want labs.

What I can prescribe without ever being in the room

Systemic estrogen, as a patch, gel, spray or tablet. A progestogen alongside it if you still have a uterus, because unopposed estrogen is what drives endometrial risk. Low dose vaginal estrogen for dryness and painful sex, which barely registers systemically and is the most underused prescription in midlife women’s health.

The non-hormonal side has moved recently and plenty of people have not caught up. Fezolinetant (Veozah) was approved in May 2023 and blocks the NK3 receptor (2). Elinzanetant (Lynkuet) followed on October 24, 2025, and blocks NK1 as well as NK3, which is why the OASIS trials picked up an effect on sleep disruption and not only on hot flashes. Dosing is 120 mg daily (3). Where sleep is the dominant complaint rather than the flashes themselves, the agent with an actual sleep signal behind it is the more logical place to start.

Paroxetine at 7.5 mg and gabapentin are both still reasonable, particularly for women who cannot take estrogen at all.

One boxed warning came off. One did not.

On November 10, 2025, the FDA moved to strip the boxed warnings for cardiovascular disease, breast cancer and probable dementia from estrogen-containing menopause products (4). The endometrial cancer warning on systemic estrogen-only products stayed exactly where it was, and that is the part the coverage mostly dropped.

My read is that this fixed a labeling problem rather than a science problem. Nothing underneath changed in November. What changed is that a warning drawn from a trial population averaging 63 years old had spent two decades frightening 52 year olds away from a treatment whose risk profile depends enormously on how old you are when you start it. I wrote about that separately.

The thing a video visit cannot do, and it just got harder

Bleeding after menopause needs an in-person evaluation. Not a phone call, not reassurance, not wait and see.

ACOG updated this in April 2026 and it moved in the stricter direction. Transvaginal ultrasound on its own is no longer considered adequate initial triage for postmenopausal bleeding. The recommendation now is ultrasound together with endometrial tissue sampling in most patients (5). Relying on ultrasound alone appears to miss 5 to 12 percent of cancers, and the old 4 mm endometrial thickness cutoff performed especially badly in Black women, with a sensitivity around 47.5 percent (5).

Read that number again. A triage rule that caught fewer than half the cancers in one group of women was standard practice until this year.

So when a patient tells me on video that she is a year past her last period and bleeding again, the visit stops being about hot flashes and becomes about getting her seen and scanned quickly by someone who can put instruments on the problem. That is not telemedicine failing. That is telemedicine doing the one thing it can do in that moment, which is recognizing what it is looking at and moving.

Same goes for a new breast lump, for pelvic pain, and for anything needing a speculum, an IUD, a mammogram or a bone density scan.

What the visit actually looks like

Expect questions, a lot of them. When your last period was. What the flashes are doing to your sleep and your work. Whether sex has become painful, which almost nobody volunteers unless asked directly. Your personal and family history of breast cancer, clotting, stroke and heart disease. Whether you get migraines with aura.

I will ask what your blood pressure has been running, and if you do not own a cuff I will ask you to get one, because starting systemic estrogen without knowing that number is not something I am willing to do. I will ask when your last mammogram was, and I will ask again at follow-up. The biggest failure mode in virtual menopause care is a woman who feels wonderful on therapy and quietly slides three years behind on screening.

Labs, when they are warranted, get ordered to a draw site near you. Prescriptions go to your pharmacy the same day.

For clinicians

Licensure is the whole ballgame. You need a license in the state where the patient is physically sitting during the visit, not where she gets her mail, and telehealth prescribing of estrogen is otherwise permitted across all fifty states on that basis.

On my own panel, roughly 25 percent of the women arrive already on hormone therapy started somewhere else, usually a direct-to-consumer platform. That number tells you what kind of visit you are actually having. Much of the time you are not initiating therapy, you are inheriting it, and the first job is working out what she is on, at what dose, and whether anyone ever screened her for a contraindication.

Two things worth tightening. Document the contraindication screen explicitly rather than letting it sit implicitly in the note, because the labeling change has patients arriving expecting a prescription and expecting it that day. And build a real handoff to a local gynecologist before you need one. After the April 2026 update, a postmenopausal bleeding referral carries a specific expectation about what the workup should include, and telling someone to go see somebody is not a plan.

The Bottom Line

Most of menopause care transfers to video without losing anything. The diagnosis is clinical, the history is the test, and hormone therapy, the two neurokinin antagonists and the non-hormonal alternatives can all be started and adjusted remotely by someone licensed where you are.

What does not transfer is anything needing hands. Bleeding after menopause is the one to take seriously, and as of April 2026 the standard for evaluating it went up, not down.

If you have been waiting until March to ask someone about this, you do not have to.

Related Reading

FDA Removes Black Box Warning From Menopause Hormone Therapy

Perimenopause and Menopause Symptoms and How to Manage Them

Vaginal Dryness After Menopause: Why It Doesn’t Go Away

Does Menopause Cause Weight Gain, or Is It Just Aging?

Why Some Conditions Need an In-Person Visit, Not Virtual Care

More on Menopause & Women’s Health

Scott Rennie, D.O.
Board Certified in Obesity Medicine and Family Medicine

This blog is for educational purposes only and does not constitute individual medical advice. Always consult your own physician before making changes to your health, medications, or treatment plan.

Sources

1. National Institute for Health and Care Excellence. Menopause: identification and management. https://www.nice.org.uk/guidance/ng23

2. U.S. Food and Drug Administration. FDA Approves Novel Drug to Treat Moderate to Severe Hot Flashes Caused by Menopause. May 12, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-novel-drug-treat-moderate-severe-hot-flashes-caused-menopause

3. FDA Approves Elinzanetant as First Nonhormonal Therapy for Menopause Vasomotor Symptoms. Pharmacy Times, October 2025. https://www.pharmacytimes.com/view/fda-approves-elinzanetant-as-first-nonhormonal-therapy-for-menopause-vasomotor-symptoms

4. U.S. Food and Drug Administration. HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy. November 10, 2025. https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy

5. American College of Obstetricians and Gynecologists. ACOG Publishes Updated Guidance on Evaluation of Postmenopausal Bleeding. April 2026. https://www.acog.org/news/news-releases/2026/04/acog-publishes-updated-guidance-evaluation-postmenopausal-bleeding

Why Menopause Care Is Missing From Women’s Checkups

On By Dr. Scott RennieIn Menopause & Women's HealthLeave a comment

I hear some version of the same question most weeks on video visits, patients trying to figure out whether what they’re feeling is actually menopause.

Women often come to me with vague but frustrating symptoms. Trouble sleeping. Brain fog. New anxiety. Irregular or heavy periods. Weight creeping up despite no major changes. Sometimes joint pain, palpitations, or new migraines. Many times, we both suspect something hormonal. The connection to menopause doesn’t always click right away.

Most of us were never taught to see the menopause transition as its own physiologic phase with real preventive implications, not because we don’t care. Medical training gives menopause a brief mention inside reproductive aging, with the emphasis staying on fertility, not on what happens once it ends. Patients ask me about hormone therapy, sleep, mood, or sexual changes, and more often than I’d like, I don’t feel equipped in the moment to explain what’s happening or lay out the options.

The average woman in the United States reaches menopause at about age 51, according to the Mayo Clinic (2024). The years leading up to that point, called perimenopause, can last four to eight years. Hormone levels fluctuate widely during this time. These shifts affect body temperature regulation, brain chemistry, metabolism, and cardiovascular function. Symptoms can begin well before the final menstrual period. A woman in her mid-forties may show up with new anxiety, fatigue, or night sweats. That’s an easy substitution to make instead of perimenopause, and it’s one I watch for now specifically because of how often it happens.

There are several reasons why menopause-related concerns get missed. Many women are still menstruating irregularly and do not yet think of themselves as menopausal; primary care visits are short and filled with competing priorities. The confusion that followed older studies on hormone therapy still lingers. I’d rather be direct about where I land: the newer safety data is solid, and hesitation still rooted in the old fear is outdated. Newer research from The Menopause Society and the National Institutes of Health shows clear safety and benefit for most healthy women under 60 or within 10 years of menopause onset (The Menopause Society, 2023; NIH, Office on Women’s Health, 2024).

I ask every woman in her forties about menstrual changes, hot flashes, sleep, mood, libido, and vaginal or urinary symptoms, because awareness starts with the question, not the answer. Simple questions open the door. If a patient raises the issue herself, I’d rather start the conversation than defer it to a specialist on the spot.

I lean on The Menopause Society’s practical resources and CME, and I’m working through their Menopause Society Certified Practitioner (MSCP) program myself. Reading Menopause Practice: A Clinician’s Guide or reviewing their treatment algorithms has strengthened my own confidence here. Other organizations such as the NIH, AAFP, and Cleveland Clinic also offer free CME courses and case examples.

Treatment doesn’t always mean prescribing systemic hormone therapy right away. I explain the range of choices and personalize them: for some patients that means hormone therapy, for others it’s non-hormonal medications, localized vaginal treatment, or lifestyle interventions. For a symptomatic perimenopausal patient who still needs contraception, I favor continuous combined hormonal contraceptives, since standard menopausal hormone therapy can produce breakthrough bleeding in that setting; a typical low-dose choice is ethinyl estradiol 20 mcg plus levonorgestrel 100 mcg orally once daily, often continuously. If contraception isn’t a factor, my usual starting menopausal regimen is transdermal 17-beta-estradiol 0.025 to 0.05 mg/day plus micronized progesterone 100 mg nightly, continuously, if the uterus is present. Weight-bearing exercise, protein intake, and good sleep remain foundational regardless of what else we add. My job is to know the options well enough to guide that discussion, and to know when a referral actually helps more than I can.

When menopause management becomes part of preventive care, patients feel seen and supported. It becomes a normal part of the health conversation, the same as colon screening or cholesterol management; I try to keep these discussions inside the relationship I already have with a patient, rather than routing her to someone new for something I can manage myself.

Menopause represents a turning point for cardiovascular, metabolic, and bone health, and recognizing it early is a real opportunity to prevent disease later. My honest read on where primary care gets this wrong: it’s decades-old caution about hormone therapy that the newer data no longer supports, not a lack of caring. Women deserve clinicians who treat that caution as outdated and prescribe with the confidence the evidence now allows.

Related Reading

Perimenopause and Menopause Symptoms and How to Manage Them Menopause Treatment by Telemedicine: How It Works How Does Aging Change Your Metabolism? What Research Shows Health Screenings Women Need and When to Get Them Does Menopause Cause Weight Gain, or Is It Just Aging? Vaginal Dryness After Menopause: Why It Doesn’t Go Away

Scott Rennie, D.O.

References:

Cleveland Clinic. Menopause and Preventive Care: What Every Woman Should Know. 2023.

The Menopause Society. Menopause Practice: A Clinician’s Guide, 6th Edition. 2023.

Mayo Clinic. Menopause: Symptoms and Causes. Updated 2024.

NIH Office on Women’s Health. Menopause and Heart Health. 2024.

Board Certified in Obesity Medicine and Family Medicine

This blog is for educational purposes only and does not constitute individual medical advice. Always consult your own physician before making changes to your health, medications, or treatment plan.