What Is Hormone Replacement Therapy? Types, Benefits, Risks

Hormone replacement therapy, defined

Around menopause, the ovaries make much less estrogen and progesterone. That drop causes hot flashes, night sweats, poor sleep, vaginal dryness, and changes in mood, and it speeds bone loss. Hormone replacement therapy gives back enough estrogen to ease those symptoms, with a progestogen added for women who still have a uterus.

You will see two names for the same treatment. Many clinicians and medical societies now say menopausal hormone therapy or simply hormone therapy, and reserve "replacement" for women whose menopause comes early, before 40, when the hormones are replacing what the ovaries would normally still produce. In everyday use, HRT covers both.

In men, hormone replacement therapy almost always means testosterone, for men whose levels are consistently low and who have symptoms of deficiency. That is covered briefly below and in depth in HRT for men.

Types of hormone replacement therapy

Type	What it is	Usually for	Main uses
Systemic estrogen alone	Estrogen as a pill, patch, gel, spray, or vaginal ring that reaches the whole body	Women who have had a hysterectomy	Hot flashes, night sweats, sleep, bone protection
Systemic combined therapy	Estrogen plus a progestogen (progesterone or a progestin)	Women who still have a uterus	The same symptoms, with the progestogen protecting the uterine lining
Low-dose vaginal estrogen	Estrogen as a vaginal cream, tablet, or ring, with very little reaching the blood	Women with vaginal and urinary symptoms	Dryness, painful sex, some bladder symptoms
Testosterone	Injections, gels, patches, pellets, and other forms	Men with symptoms and consistently low testosterone	Sex drive, energy, muscle, bone

Systemic versus local (vaginal) therapy

Systemic hormone therapy reaches the whole body. It comes as pills, skin patches, gels, sprays, or a higher-dose vaginal ring, and it is what treats hot flashes and night sweats. Local therapy is low-dose estrogen placed in the vagina as a cream, tablet, or ring. It treats the genitourinary syndrome of menopause: dryness, irritation, painful sex, and some bladder symptoms. The Menopause Society notes that very little of it reaches the bloodstream, so its risks are far lower than those of systemic therapy.

Estrogen alone versus combined therapy

Estrogen taken on its own thickens the lining of the uterus and raises the risk of endometrial cancer. Women who still have a uterus therefore take a progestogen with it. In one 2025 review of the trial evidence, endometrial hyperplasia, the precancerous thickening, occurred in 34% of women on estrogen alone versus 1% on combined therapy. Women who have had a hysterectomy can usually take estrogen alone.

Combined therapy can be continuous, with both hormones every day, or cyclic, with estrogen daily and the progestogen for 12 to 15 days each month, which usually brings a monthly bleed.

Pill or skin

The route matters. Estrogen taken by mouth passes through the liver first, which raises clotting factors. Estrogen absorbed through the skin from a patch, gel, or spray avoids that first pass, and The Menopause Society notes the risk of blood clots may be lower with this route. For women with a higher baseline risk of clots, a non-oral route is often preferred.

What hormone replacement therapy can help with

Hot flashes and night sweats. These vasomotor symptoms are the main reason women start systemic therapy.
Sleep, irritability, and "brain fog" that come with night sweats and hormonal change.
Vaginal dryness and painful sex. Women on low-dose systemic therapy sometimes need vaginal estrogen as well.
Bladder symptoms. Vaginal estrogen may help overactive bladder and recurrent urinary tract infections.
Bone. Standard-dose hormone therapy helps prevent fractures. The 2025 review cited below reported fracture reductions of 20% to 37% across hip, vertebral, and total fractures.

Women whose ovaries are removed before age 45 have a particular reason to consider therapy, since it can reduce risks tied to early loss of estrogen, such as osteoporosis. The Menopause Society notes that women with early menopause may be able to take hormones earlier or for longer.

Risks, and why age and timing matter

The risks of hormone therapy depend on who takes it, when they start, which hormones they take, and by which route. The most important variable is timing. The Menopause Society's position is that for most women, hormone therapy helps control moderate to severe symptoms when it is started within 10 years of the onset of menopause or before age 60. Cleveland Clinic notes that heart disease risk is higher when therapy starts 10 or more years after menopause, and that starting in the 40s or 50s is typically not linked to higher cardiovascular risk.

Blood clots and stroke

Both estrogen alone and combined therapy raise the risk of stroke, and The Menopause Society notes that this risk fades soon after therapy stops. Blood clot risk is higher with oral estrogen and may be lower with transdermal estrogen.

Breast cancer

Breast cancer risk differs by type. In the Women's Health Initiative trials summarized by the National Cancer Institute, estrogen alone was associated with a lower risk of breast cancer and of dying from it, while estrogen plus progestin increased the risk, and that increase persisted for at least a decade after women stopped. The Menopause Society notes that risk does not rise for about 7 years with estrogen alone, and rises after about 3 to 5 years with combined therapy. Cleveland Clinic describes the increase in most studies as small, under 1 in 1,000. Combined therapy also increases breast density, which can make mammograms harder to read.

Uterine cancer and bleeding

Estrogen without a progestogen raises endometrial cancer risk in women with a uterus. Combined therapy can cause irregular bleeding, and bleeding that is new or persistent should be evaluated, which sometimes means a biopsy of the uterine lining.

Other effects

Hormone therapy also raises the risk of gallbladder disease. Common side effects in the first months include breast tenderness, irregular bleeding, bloating, headaches, and mood changes, and most settle within a few months or with a change in dose or form.

Who usually should not take systemic HRT

Current or past breast, uterine, or ovarian cancer
Unexplained vaginal bleeding
A history of blood clots, or a high risk of them
A past stroke or heart attack, or high cardiovascular risk
Active liver disease or gallbladder disease
Pregnancy

What the FDA changed in 2025 and 2026

Since the early 2000s, menopausal hormone products have carried a boxed warning about heart disease, breast cancer, and dementia, and the FDA notes that many women avoided treatment because of it. On November 10, 2025, the FDA asked manufacturers to remove the language about cardiovascular disease, breast cancer, and probable dementia from the boxed warning, along with the advice to use the lowest dose for the shortest time. On February 12, 2026, it approved the first six updated labels.

Three details matter. The boxed warning about endometrial cancer stays on systemic estrogen-alone products. Cardiovascular and breast cancer risks remain in the Warnings and Precautions section of systemic product labels. And the updated labels add that women with moderate to severe hot flashes may consider starting systemic therapy before age 60 or within 10 years of menopause. The change brings the label closer to how menopause specialists already weigh timing. Your individual risk assessment matters as much as before.

Bioidentical, FDA-approved, and compounded hormones

"Bioidentical" means a hormone has the same chemical structure as the one your body makes. Many FDA-approved products are bioidentical, including estradiol patches, gels, and pills and micronized progesterone. These have been tested for safety, effectiveness, and consistent dosing.

Compounded bioidentical hormones are mixed by a pharmacy to a custom formula. They are not FDA-approved, they are not tested for safety or effectiveness, and the amount of hormone in each dose may differ from the label. The Menopause Society states that custom-compounded hormones are not safer or more effective than approved bioidentical products, and it warns that too little progesterone can leave the uterus unprotected while too much estrogen can overstimulate the uterine lining and breast tissue. For most women, an FDA-approved bioidentical product gives the benefits people look for in compounded hormones with far more certainty about the dose.

Hormone replacement therapy for men

In men, HRT means testosterone. The Endocrine Society recommends treatment only for men who have symptoms of deficiency and consistently low testosterone, confirmed by repeating a fasting morning blood test. It recommends against routinely treating all men 65 or older with low levels, and against testosterone in men planning to father a child soon, because it suppresses sperm production.

The largest safety trial, TRAVERSE, followed 5,246 men aged 45 to 80 with existing heart disease or high cardiovascular risk. Major cardiac events occurred in 7.0% of men on testosterone gel and 7.3% on placebo, while atrial fibrillation, acute kidney injury, and pulmonary embolism were more common with testosterone. Men on therapy need monitoring of testosterone levels, hematocrit, and, for many, PSA. Read the full guide to HRT for men for diagnosis, options, fertility, and cost.

How long to stay on HRT

There is no universal stopping point. Cleveland Clinic notes that most women use hormone therapy for five years or less, but there is no fixed limit. The Menopause Society says there is no single right time to stop. Many women try stopping after 4 to 5 years, and tapering slowly over months may reduce the return of hot flashes, though that has not been proven in studies. The 2025 review cited below reports that roughly half of women have symptoms again after stopping. Because risks can increase with age and longer use, the decision to continue deserves a fresh look each year.

Monitoring on hormone therapy

MedlinePlus advises follow-up every three to six months at first, then yearly once treatment is working well. Monitoring usually covers:

Symptom relief and side effects, with dose or route adjusted
Blood pressure, weight, and cardiovascular risk factors
Any unexpected vaginal bleeding, which needs evaluation
Breast cancer screening on schedule
Bone density when there is a fracture risk
For men on testosterone: testosterone level, hematocrit, and PSA where appropriate

Testosterone therapy in men is dosed by blood levels, and the Endocrine Society suggests aiming for the mid-normal range.

If HRT is not right for you

Women who cannot or prefer not to take hormones have options. Fezolinetant and paroxetine are FDA-approved specifically for hot flashes. Gabapentin, oxybutynin, and clonidine are approved for other conditions and can also reduce hot flashes. Over-the-counter vaginal lubricants help with dryness and painful sex.

How to decide whether HRT is right for you

The decision comes down to how much your symptoms affect your life and what your personal risks look like. Questions worth working through with your physician:

How much are hot flashes, sleep loss, or vaginal symptoms affecting daily life?
How long has it been since your last period, and how old are you?
Do you still have a uterus, which determines whether you need a progestogen?
Do you have a personal or family history of breast cancer, blood clots, stroke, or heart disease?
Would a patch or gel suit your risk profile better than a pill?
Are your symptoms mainly vaginal, in which case low-dose vaginal estrogen may be enough?
When will you reassess, and how will you know it is working?

Frequently asked questions

What is hormone replacement therapy in simple terms?

Hormone replacement therapy is a prescription that replaces hormones your body has stopped making in adequate amounts. For women it usually means estrogen, plus a progestogen if the uterus is intact, to treat menopause symptoms. For men it usually means testosterone for levels that are confirmed low on repeat blood tests.

Is hormone replacement therapy safe?

For healthy women with moderate to severe symptoms, The Menopause Society supports hormone therapy started within 10 years of menopause or before age 60, and the FDA's updated labels describe the same window. Risk rises with older age at the start, longer use, oral estrogen in women prone to clots, and certain health histories such as breast cancer, stroke, or blood clots. Your own history decides whether it is safe for you.

Does HRT cause breast cancer?

It depends on the type. In the Women's Health Initiative, estrogen alone was linked to a lower risk of breast cancer, while estrogen plus progestin raised the risk, and that higher risk lasted for at least a decade after stopping. The Menopause Society notes that with combined therapy the risk starts to rise after about 3 to 5 years.

What is the safest form of hormone replacement therapy?

Low-dose vaginal estrogen has the lowest risk because very little enters the bloodstream, but it only treats vaginal and urinary symptoms. For systemic treatment, estrogen through the skin may carry a lower risk of blood clots than estrogen by mouth. The safest choice for you depends on your symptoms, whether you have a uterus, and your health history.

What is the difference between HRT and hormone therapy?

They describe the same treatment. Cleveland Clinic notes that clinicians often say hormone therapy for women over 50 and hormone replacement therapy for younger women, especially those whose menopause begins before 40, because in that group the hormones are replacing what the ovaries would normally still make.

How long can you stay on HRT?

There is no fixed limit. The Menopause Society says there is no single right time to stop, and many women try stopping after 4 to 5 years. Because risks can rise with age and longer use, the decision to continue should be reviewed with your physician at least once a year.

Are bioidentical hormones safer than regular HRT?

Several FDA-approved products are already bioidentical, including estradiol and micronized progesterone. Custom-compounded bioidentical hormones are not FDA-approved, and The Menopause Society states they are not safer or more effective than approved bioidentical products. Compounded doses can also vary, which can leave the uterus unprotected.

Can men take hormone replacement therapy?

Yes. For men, hormone replacement therapy means testosterone, and the Endocrine Society recommends it only for men with symptoms and consistently low morning testosterone levels. It is not appropriate for men with normal levels, and it lowers sperm production, so men planning a pregnancy soon should discuss other options first.

Hormone therapy in Miami

I treat menopause symptoms and low testosterone in Miami with plans built on your symptoms, your history, and lab work, and I recheck labs after we start so the dose fits how you actually respond. If you are a man wondering about testosterone, start with my guide to HRT for men. To see how I approach treatment, read about hormone replacement therapy in Miami, or book a consultation and we can go through your options together.