Update: Hormone Therapy for Menopause

What is this update about?

Menopause is a natural stage of life, usually happening between ages 45 and 55, when menstrual periods stop, and hormone levels drop. Some women experience menopause earlier, due to surgery or cancer treatment. Menopausal hormone therapy consists of treatment that replaces one or more of the hormones your body no longer makes.

The FDA recently updated its guidance to remove some of the strongest warning labels from these treatments. In the past, hormone therapy carried the strongest type of warning label from the FDA, highlighting serious risks like heart disease, breast cancer and dementia. This led many women to avoid these treatments.

Based on recent data, the FDA requested that all hormone therapy products containing estrogen or progestogen in all dose forms remove language about the risk of cardiovascular disease, breast cancer and probable dementia from the boxed warning. The FDA also requested other safety-related labeling changes.

This change is meant to reflect what we now know: menopausal hormone therapy can be a reasonable option for relieving symptoms in many women.

However, it’s important to know that hormone therapy still has risks. The risks have not gone away, but they are now explained in a more balanced way that allows people to have a conversation with their doctor and share in decision-making, rather than using a one-size-fits-all warning.

Why is this update important?

The menopause experience is different for each individual, and symptoms vary between people. For some, menopause means a few annoying symptoms, but for others, it may bring symptoms that can seriously affect daily life. In general, the earlier in life that menopause happens, the more intense the symptoms may be. Common symptoms include:

• Hot flashes
• Night sweats
• Trouble sleeping
• Decreased libido, vaginal dryness or painful sex
• Bone thinning (osteoporosis)
• Joint pain
• Fatigue
• Mental fog

Menopausal hormone therapy

The most commonly used hormones are estrogen and progestins.

Although menopausal hormone therapy has been used for many years to address menopause symptoms, it is important to know the following:

1. Hormone therapy can help relieve symptoms

It’s effective for:

• Hot flashes and night sweats
• Sexual side effects
• Preventing bone loss (in some cases)
• Improving sleep
• Addressing fatigue and mental fog

2. Different types of hormone combinations are available

Your doctor may recommend:

• Estrogen alone (often after hysterectomy)
• Estrogen + progesterone (if you still have a uterus)
• Occasionally, testosterone may be added to menopausal hormone therapy to address loss of libido.

3. Different types of hormone preparations are available
Menopausal hormone therapy comes in different forms, and each has benefits and risks. You can read more about this process under the “How the hormone preparation is made” section of the page linked here.

4. Hormones may be delivered to the body in different ways

Hormone delivery methods may include systemic, intrauterine or vaginal options.

• Systemic hormones (patches, creams or pills) enter the bloodstream and affect the whole body. These are most effective for treating menopause symptoms but may cause more side effects. Although oral estrogen increases the risk of blood clots, transdermal (e.g. patch) estrogen does not appear to elevate the risk of clotting.
• Intrauterine hormones (such as intrauterine devices or IUDs) deliver progesterone directly to the uterus to protect against endometrial cancer. Intrauterine progesterone has fewer side effects than systemic progesterone. 
• Local low-dose vaginal hormones (such as Estring 3-month ring, Vagifem twice-weekly tablets, Estrace cream, Premarin cream, Intrarosa tablets or Imvexxy inserts) deliver hormones to the vaginal walls with minimal absorption to the bloodstream. They are useful for localized symptoms (such as dryness or discomfort with penetration) and are often safer for people who cannot safely take systemic hormones. 

5. One size does not fit all

Hormone therapy may not be safe for everyone, especially for those who have:

• A history of breast cancer
• Blood clots, stroke or heart disease
• Liver problems

6. Timing matters

• Starting hormones early in menopause could be safer and more beneficial, depending on several factors.
• Starting hormone therapy later (especially after age 60) may carry more risks.
• Menopausal women of any age can safely use local, low-dose vaginal hormones.

7. You have options

If hormones aren’t safe or aren’t the right choice for you, FDA-approved, non-hormonal treatments are also available.

Special considerations for breast cancer survivors

Hormone therapy has traditionally been avoided in people with a history of breast cancer, especially hormone receptor–positive breast cancer, because estrogen can stimulate cancer growth and increase the risk of recurrence. However, a recent international expert consensus suggests this approach may be overly restrictive for some individuals and supports more personalized decision‑making for those with severe menopause symptoms.

• Local low‑dose vaginal hormone therapies are minimally absorbed into the bloodstream and are unlikely to increase breast cancer recurrence risk; they may be an option when non‑hormonal treatments do not relieve vaginal symptoms.
• Systemic hormone therapy may increase recurrence risk for some people—especially within the first 5–10 years after a breast cancer diagnosis—but this risk varies by individual cancer factors and is often small.

People with low‑ or medium‑risk breast cancer who experience severe, life‑disrupting menopause symptoms may choose to consider systemic hormone therapy to improve quality of life. Experts emphasize that the decision should be made through shared decision-making, taking into account cancer type, time since diagnosis, severity of symptoms, personal values and alternative treatment options.

What does this mean for me?

If you’re struggling with menopause symptoms, hormone therapy may be a more reasonable option than many people once believed. The FDA has updated its guidance to better reflect current research, removing some of the strongest warning labels that may have discouraged doctors from prescribing and women from considering hormone treatment in the past.

This doesn’t mean hormone therapy is risk-free, but it does mean the risks depend on your age, health history and when you start treatment. For many women, including those early in menopause, the benefits can outweigh the risks.

It’s important to find a menopause expert who will consider your unique set of circumstances when formulating a plan that’s right for you. The Menopause Society is a professional society of experts in managing menopause symptoms with and without hormones. You can use their tool to find a menopause expert near you. 

This update is meant to help you have a more informed, personalized conversation with your healthcare team about whether hormone therapy could improve your quality of life. If menopause symptoms are affecting your quality of life, discuss options with your healthcare provider.

Reference

U.S. Food and Drug Administration (FDA). (2026). Hormone replacement therapies can help women with bothersome menopausal symptoms. 

eCancer. (2025). Experts call for change of heart on hormone replacement therapy after breast cancer.

 

Disclosure: FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.

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posted 4/27/2026