Menopause Symptom Management: Who Can Have Hormone Therapy, Who Cannot and the Nonhormone Options
Under the 2022 NAMS hormone therapy position statement, healthy women younger than 60 or within 10 years of menopause onset who have bothersome hot flashes have a favorable benefit-risk balance for systemic hormone therapy, with a progestogen added whenever a uterus is present. Hormone therapy is contraindicated with unexplained vaginal bleeding, breast or other estrogen-dependent cancer, prior venous thromboembolism or stroke, coronary disease and active liver disease. For women who cannot or will not take hormones, the 2023 nonhormone statement recommends CBT, clinical hypnosis, SSRIs or SNRIs, gabapentin, fezolinetant and oxybutynin.
Hormone therapy (HT) is the most effective treatment for hot flashes and night sweats, and the board question is almost always about eligibility. The 2022 position statement of The North American Menopause Society (NAMS, now The Menopause Society) says that for women younger than 60 or within 10 years of menopause onset without contraindications, the benefit-risk ratio favors HT for bothersome vasomotor symptoms and for prevention of bone loss. Women with unexplained vaginal bleeding, breast cancer, prior venous thromboembolism (VTE) or stroke, coronary disease or active liver disease should not take it, and for them the 2023 NAMS nonhormone statement lists effective alternatives: cognitive behavioral therapy (CBT), clinical hypnosis, SSRIs and SNRIs, gabapentin, fezolinetant and oxybutynin.
Assessment
Confirm the diagnosis
Menopause is diagnosed clinically after 12 months without menses in a woman of typical age (average about 51) without another cause. Laboratory tests are not needed in a woman over 45 with typical symptoms. Measure FSH and rule out pregnancy, thyroid disease and hyperprolactinemia when amenorrhea and hot flashes start before 40 (primary ovarian insufficiency) or between 40 and 45 (early menopause). FSH is unreliable during perimenopause, when values fluctuate, and in women using hormonal contraception.
Characterize symptoms and risk
- Vasomotor symptoms (VMS): frequency, severity, night sweats, sleep disruption and effect on work and mood.
- Genitourinary syndrome of menopause (GSM): vaginal dryness, dyspareunia, burning, urgency, dysuria and recurrent urinary tract infections.
- Mood, sleep and cognition complaints, which often travel with VMS.
- Risk review that drives eligibility: age and years since final menstrual period, breast cancer personal and family history, VTE and stroke history, coronary disease and calculated cardiovascular risk, liver disease, migraine with aura, smoking, BMI, bone density and fracture risk, and whether the uterus is present.
- Up-to-date mammography and evaluation of any postmenopausal bleeding before starting therapy.
Who can have hormone therapy
The timing rule
| Patient | NAMS 2022 position |
|---|---|
| Younger than 60 or within 10 years of menopause onset, no contraindications | Benefit-risk favorable for bothersome VMS and prevention of bone loss |
| 60 or older, or more than 10 years from onset | Benefit-risk less favorable because of greater absolute risks of coronary heart disease, stroke, VTE and dementia; consider only with careful individual assessment |
| Primary ovarian insufficiency or early menopause | HT recommended until at least the average age of natural menopause unless contraindicated |
| Bothersome GSM only, no indication for systemic HT | Low-dose vaginal estrogen, vaginal DHEA (prasterone) or oral ospemifene after over-the-counter moisturizers and lubricants fail |
Building the regimen
- Uterus present: estrogen plus a progestogen (oral or micronized progesterone, or a levonorgestrel IUD), or conjugated estrogens with bazedoxifene. Unopposed estrogen with a uterus increases endometrial hyperplasia and cancer risk.
- No uterus (hysterectomy): estrogen alone.
- Route: transdermal estradiol (patch, gel or spray) is associated in observational studies with lower risks of VTE and stroke than oral estrogen and is the preferred choice for women with obesity, hypertriglyceridemia, migraine or increased VTE risk who are otherwise eligible.
- Dose and duration: use the appropriate dose and duration for the individual woman's goals, reassessed at least yearly. NAMS 2022 rejects an automatic stop at 60 or 65; longer use is a shared decision for documented indications.
- Compounded bioidentical hormones are not recommended because of variable dosing and lack of safety data.
The Women's Health Initiative findings that drove the old fear of HT came from women whose average age was 63, many years past menopause. Their absolute risks do not transfer to a healthy 52-year-old.
Bone and the special case of early menopause
NAMS 2022 lists prevention of bone loss and fracture as an established benefit of HT, so a recently menopausal woman with VMS and low bone mass gets two benefits from one therapy. For a woman whose only problem is osteoporosis and who has no VMS, HT is not the default first choice, particularly after 60; standard osteoporosis agents are used. Women with primary ovarian insufficiency or surgical menopause before the usual age face higher risks of bone loss, cardiovascular disease and cognitive change from early estrogen loss. For them HT is replacement of what the ovaries would normally produce, and the age-60 and 10-year cautions that apply to natural menopause do not apply until they reach the average age of menopause. A woman with primary ovarian insufficiency who still wants contraception needs counseling that HT doses are not reliably contraceptive.
Who cannot have hormone therapy
| Contraindication to systemic HT | Practical implication |
|---|---|
| Unexplained vaginal bleeding | Evaluate first (transvaginal ultrasound or endometrial biopsy) |
| Known, suspected or past breast cancer | Use nonhormone options; vaginal estrogen only in consultation with oncology |
| Other estrogen-dependent cancer (for example endometrial) | Oncology input |
| Active or past VTE, or known thrombophilia | Nonhormone options |
| Prior stroke or transient ischemic attack | Nonhormone options |
| Coronary heart disease, myocardial infarction | Nonhormone options |
| Active liver disease | Nonhormone options |
| Pregnancy | Not applicable to menopause but listed on labels |
High calculated cardiovascular risk, a history of gallbladder disease, migraine with aura and hypertriglyceridemia are not absolute contraindications; they shift the choice toward transdermal estradiol or a nonhormone option.
In November 2025 the FDA announced removal of the boxed warning language on cardiovascular disease, breast cancer and probable dementia from menopausal HT labels, while retaining the endometrial cancer boxed warning for systemic estrogen-alone products. Clinical contraindications did not change, and exam items continue to test them.
Nonhormone therapy: NAMS 2023
| Category | Recommended (evidence level) | Not recommended |
|---|---|---|
| Behavioral | CBT (Level I); clinical hypnosis (Level I); weight loss (Levels II to III) | Paced respiration; mindfulness; relaxation; cooling techniques; avoiding triggers; exercise and yoga for VMS (exercise remains good for general health) |
| Prescription | SSRIs and SNRIs (Level I); gabapentin (Level I); fezolinetant (Level I); oxybutynin (Levels I to II) | Clonidine (adverse effects, limited benefit); pregabalin; suvorexant |
| Procedural | Stellate ganglion block (Levels II to III) | |
| Supplements | None | Black cohosh, soy and isoflavones, other herbal products, cannabinoids, acupuncture, chiropractic care |
Doses from the NAMS 2023 table
| Drug | Dose range | How to start |
|---|---|---|
| Paroxetine mesylate (salt) | 7.5 mg daily | FDA approved for VMS; no titration |
| Paroxetine | 10 to 25 mg daily | Start 10 mg |
| Citalopram | 10 to 20 mg daily | Start 10 mg |
| Escitalopram | 10 to 20 mg daily | Start 10 mg |
| Venlafaxine | 37.5 to 150 mg daily | Start 37.5 mg |
| Desvenlafaxine | 100 to 150 mg daily | Start 25 to 50 mg and titrate |
| Gabapentin | 900 to 2,400 mg daily | Start 100 to 300 mg at bedtime and titrate; useful when night sweats disrupt sleep |
| Oxybutynin | 2.5 to 5 mg twice daily, or extended release up to 15 mg daily | Anticholinergic: caution in older women because of cognitive effects |
| Fezolinetant | 45 mg once daily | FDA approved for VMS; no titration |
Fezolinetant details
Fezolinetant is a neurokinin 3 receptor antagonist that acts on the hypothalamic thermoregulatory center. In December 2024 the FDA added a boxed warning for rare serious liver injury. Hepatic tests (aminotransferases and bilirubin) are obtained before starting, then monthly for the first 3 months and at 6 and 9 months, and the drug is not started when values are 2 times the upper limit of normal or higher. The label also lists cirrhosis, severe renal impairment and concurrent CYP1A2 inhibitors as contraindications; confirm the full list in the current prescribing information. Elinzanetant, a dual neurokinin 1 and 3 receptor antagonist, was approved by the FDA in October 2025, after the 2023 statement.
Matching the drug to the patient
- Breast cancer on tamoxifen: avoid paroxetine and fluoxetine (strong CYP2D6 inhibitors that reduce conversion to endoxifen); venlafaxine, citalopram, escitalopram or gabapentin are better choices.
- Coexisting depression or anxiety: an SSRI or SNRI treats both.
- Night sweats with insomnia: gabapentin at bedtime.
- Overactive bladder: oxybutynin, with cognitive caution in older women.
- Wants a nonhormone, non-antidepressant drug and has normal liver tests: fezolinetant.
Genitourinary syndrome of menopause
GSM is chronic and progressive, unlike VMS, which usually wane. Start with vaginal moisturizers used regularly and lubricants with intercourse. If symptoms persist, low-dose vaginal estrogen (cream, tablet or ring) is effective, does not require a progestogen at standard doses, and is not limited to a set duration. Vaginal DHEA and oral ospemifene are alternatives. Vaginal estrogen also reduces recurrent urinary tract infections in postmenopausal women. In breast cancer survivors, nonhormone options come first, and vaginal estrogen is a decision made with the oncologist.
Monitoring and follow-up
- Recheck a few months after starting or changing therapy for effect and side effects (breast tenderness, bleeding, headache), then at least yearly, as NAMS advises periodic reassessment of benefits and risks.
- Any unscheduled bleeding after the first months of continuous combined therapy, or any bleeding after a period of amenorrhea, requires endometrial evaluation.
- Continue age-appropriate mammography and bone density screening.
- Fezolinetant: hepatic tests on the schedule above and immediate stop for jaundice, dark urine, right upper quadrant pain or unusual fatigue.
- SSRIs and SNRIs: when stopping, taper to avoid discontinuation symptoms.
Referral triggers
Refer for postmenopausal bleeding needing biopsy or hysteroscopy, primary ovarian insufficiency (endocrine or reproductive specialist and fertility counseling), breast cancer survivors with refractory symptoms (oncology), or persistent severe symptoms despite first-line therapy (menopause specialist).
Patient education
Explain that VMS last a median of several years and that HT started near menopause has a different risk profile than HT started a decade later. Discuss the specific absolute risks that apply to her age and history, the need for a progestogen with a uterus, the bleeding pattern to expect, and the plan for yearly review. Lifestyle measures such as weight loss can help, while layered clothing and avoiding triggers are reasonable comfort measures even though the evidence for them is weak.
How the exam tests this
- Age and timing: a 54-year-old 3 years past menopause is the ideal HT candidate; a 68-year-old 18 years past menopause is not.
- Uterus trap: estrogen alone in a woman with a uterus is always wrong for systemic therapy.
- Breast cancer trap: systemic HT by any route is wrong; nonhormone therapy is right, and paroxetine is wrong if she takes tamoxifen.
- Route trap: when an otherwise eligible woman has obesity or migraine, transdermal estradiol is safer than oral.
- Supplement trap: black cohosh and soy are not recommended.
- Clonidine trap: clonidine appears as a "nonhormone" choice but is not recommended in the 2023 statement.
- FSH trap: a 52-year-old with a year of amenorrhea and hot flashes does not need an FSH level.
Practice question
A 51-year-old woman reports 10 to 12 hot flashes a day and night sweats that wake her three times nightly, starting after her final menstrual period 14 months ago. She completed treatment for estrogen receptor-positive breast cancer last year and takes tamoxifen. She has no history of depression. Blood pressure is 124/78 mm Hg, and liver tests are normal. Which treatment is most appropriate?
- A. Transdermal estradiol 0.05 mg patch with oral micronized progesterone.
- B. Paroxetine mesylate 7.5 mg daily.
- C. Venlafaxine extended release starting at 37.5 mg daily.
- D. Black cohosh extract twice daily.
Answer: C. A history of breast cancer is a contraindication to systemic hormone therapy, so a nonhormone option is needed, and venlafaxine is effective for VMS without meaningfully inhibiting CYP2D6, which tamoxifen needs for activation. Option A is wrong because the transdermal route does not remove the breast cancer contraindication. Option B is FDA approved for VMS, but paroxetine is a strong CYP2D6 inhibitor that can reduce tamoxifen's effectiveness. Option D is not recommended in the 2023 NAMS statement because of insufficient evidence of benefit.
Key points
- HT benefit-risk is favorable for women younger than 60 or within 10 years of menopause onset without contraindications; it is less favorable after that.
- Add a progestogen whenever a uterus is present; transdermal estradiol carries lower VTE and stroke risk than oral in observational data.
- Contraindications: unexplained vaginal bleeding, breast or estrogen-dependent cancer, VTE, stroke, coronary disease and active liver disease.
- There is no mandatory stop age; reassess at least yearly with shared decision-making.
- NAMS 2023 recommended nonhormone options: CBT, hypnosis, SSRIs and SNRIs, gabapentin, fezolinetant 45 mg and oxybutynin; not recommended: clonidine, supplements, paced respiration.
- Avoid paroxetine with tamoxifen; check liver tests before and during fezolinetant.
- Low-dose vaginal estrogen treats GSM without a progestogen.
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Frequently asked questions
Common follow-up questions on Pediatrics & Women's Health (FNP).
Does hormone therapy have to stop at age 65?
No. NAMS 2022 states there is no arbitrary age at which hormone therapy must stop. Continuing beyond 65 is a shared decision for documented indications such as persistent hot flashes, with periodic reassessment of benefits and risks.
Does vaginal estrogen need a progestogen?
Low-dose vaginal estrogen for genitourinary syndrome of menopause has minimal systemic absorption, and a progestogen is not generally needed for endometrial protection. Postmenopausal bleeding on vaginal estrogen still requires evaluation.
Which nonhormone drug should be avoided in a woman taking tamoxifen?
Paroxetine and fluoxetine strongly inhibit CYP2D6, the enzyme that converts tamoxifen to its active metabolite endoxifen. Venlafaxine, desvenlafaxine, citalopram, escitalopram or gabapentin are preferred in that situation.
What monitoring does fezolinetant require?
Since a December 2024 boxed warning for liver injury, hepatic laboratory tests are checked before starting, monthly for the first 3 months and at 6 and 9 months, and the drug is not started if aminotransferases or bilirubin are 2 times the upper limit of normal or higher.
Sources and references
- The 2022 Hormone Therapy Position Statement of The North American Menopause Society Advisory Panel. The 2022 hormone therapy position statement of The North American Menopause Society. Menopause. 2022. https://doi.org/10.1097/GME.0000000000002028
- The 2023 Nonhormone Therapy Position Statement of The North American Menopause Society Advisory Panel. The 2023 nonhormone therapy position statement of The North American Menopause Society. Menopause. 2023. https://doi.org/10.1097/GME.0000000000002200
- The 2020 Genitourinary Syndrome of Menopause Position Statement of The North American Menopause Society. Menopause. 2020. https://doi.org/10.1097/GME.0000000000001609
- US Food and Drug Administration. FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause (updated with Boxed Warning December 2024). FDA Drug Safety Communication. 2024. https://www.fda.gov/drugs/drug-safety-communications/fda-adds-warning-about-rare-occurrence-serious-liver-injury-use-veozah-fezolinetant-hot-flashes-due
- Sriprasert I, Hodis HN, Mack WJ, et al. Elimination of the Black Box Warning on Menopausal Hormone Therapy. Obstetrics and Gynecology. 2026. https://doi.org/10.1097/AOG.0000000000006226
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