Menopause Hormone Therapy: Current Evidence on Benefits and Risks

Hot flashes wake you at night. Your sleep, mood, and focus have changed. You have heard that hormone therapy helps, but you may also remember headlines from the early 2000s about breast cancer and strokes. It is hard to know what to believe.

This guide explains what the research shows now, why timing matters, and what changed on US labels in 2025.

What menopause hormone therapy is

Menopause is the time when periods stop for good, usually around age 51. Before and after it, falling estrogen levels can cause symptoms:

• Hot flashes and night sweats (vasomotor symptoms).
• Sleep problems and mood changes.
• Vaginal dryness, pain with sex, and some urinary symptoms.

Menopause hormone therapy (MHT), also called hormone replacement therapy (HRT), replaces some of the estrogen. It comes in several forms:[1]

• Systemic estrogen: pills, skin patches, gels, or sprays that treat whole-body symptoms.
• A progestogen: needed by people who still have a uterus, to protect the lining of the uterus from cancer.
• Low-dose vaginal estrogen: creams, tablets, or rings that treat vaginal and urinary symptoms.

What your doctor looks at

The main guidance

The North American Menopause Society (now called The Menopause Society) 2022 position statement says hormone therapy is the most effective treatment for hot flashes. It also prevents bone loss and fractures.[1] The Society of Obstetricians and Gynaecologists of Canada (SOGC) gives similar advice in its 2021 guideline.[2]

Key points from these guidelines:

• For healthy people under 60, or within 10 years of their last period, who have bothersome symptoms, the benefits usually outweigh the risks.[1][2]
• Starting after 60, or more than 10 years after menopause, carries higher risks of heart disease, stroke, clots, and dementia.[1]
• The type, dose, route, and length of treatment should fit each person.[1]

What the Women's Health Initiative showed

The Women's Health Initiative (WHI) was a large US trial that began in the 1990s. Its average participant was 63 years old, which is older than most people who start therapy for symptoms. For estrogen plus progestin, the trial reported these differences per 10,000 women per year, compared with placebo:[3]

• 7 more heart disease events.
• 8 more strokes.
• 8 more blood clots in the lungs.
• 8 more invasive breast cancers.
• 6 fewer colorectal cancers.
• 5 fewer hip fractures.

Later analyses found that risks were lower in women who started in their 50s. Estrogen alone, given to women without a uterus, did not raise breast cancer risk during the trial.[4]

Other risks to know

• Blood clots and stroke risk rise with estrogen pills. Observational studies suggest skin patches and gels may carry a lower clot risk.[1]
• Breast cancer risk with estrogen plus progestogen rises with longer use.[1]
• Gallbladder disease is more common with pills.

Clinicians usually avoid systemic hormone therapy if you have had breast cancer, a blood clot, a stroke, a heart attack, active liver disease, or vaginal bleeding that has not been explained.

Not for disease prevention alone

The USPSTF recommends against using hormone therapy only to prevent chronic conditions such as heart disease or dementia in postmenopausal people.[5] This advice does not apply to treating symptoms. It is about taking hormones when you do not have symptoms.

What changed in 2025

Since 2003, US labels for hormone therapy carried a boxed warning based on the WHI. On November 10, 2025, the US Department of Health and Human Services and the FDA announced removal of this boxed warning. The FDA also moved to product-specific labels, removed the advice to always use the lowest dose for the shortest time, and added guidance that starting within 10 years of menopause or before 60 is the best timing.[6]

This is a US labeling change. In Canada, Health Canada approves the product monographs, so wording may differ. In both countries, the risks above still apply. The change reflects a fuller picture of benefits and risks by age and timing.

Other treatment options

If you cannot or prefer not to use hormones, other options exist. These include some antidepressants (SSRIs and SNRIs), gabapentin, and newer non-hormonal drugs that act on brain pathways for temperature control. Cognitive behavioral therapy and some lifestyle steps can also help.[2]

Questions to ask your clinician

• Am I a good candidate for hormone therapy, given my age and time since menopause?
• Do I need a progestogen, and which one?
• Would a patch or gel be safer for me than a pill?
• What is my personal risk of breast cancer, clots, and stroke?
• Would vaginal estrogen alone treat my symptoms?
• How often should we review whether I still need it?
• What non-hormonal options do I have?

When to get care quickly

Call 911 or go to the emergency department if you have:

• Sudden chest pain or shortness of breath.
• Pain, swelling, and warmth in one leg.
• Face drooping, arm weakness, trouble speaking, or sudden vision loss.
• A sudden, severe headache.

See your clinician soon for any vaginal bleeding after menopause, or a new breast lump.

Bottom line

Hormone therapy is the most effective treatment for hot flashes. For healthy people under 60 or within 10 years of menopause, the benefits usually outweigh the risks. Risks are real but depend on age, timing, type, and route. The 2025 US label change removed the boxed warning, but the decision is still a personal one to make with your clinician.

Primary AI can show you the guideline and study sources behind this topic in plain language, so you can bring better questions to your appointment.