Hormone Therapy (MHT/HT)
FDA Updates Hormone Therapy Guidance (November 2025)
In November 2025, the FDA announced changes to labeling for menopausal hormone therapy, including the removal of several long-standing boxed-warning statements related to cardiovascular disease, breast cancer, and probable dementia from certain products.
The changes reflect a more individualized understanding of the benefits and risks of hormone therapy, including the importance of a woman’s age, symptoms, health history, type of therapy, and timing of treatment.
What is Menopausal Hormone Therapy?
Menopausal hormone therapy (MHT), sometimes called hormone replacement therapy (HRT), uses hormones, most commonly estrogen, with a progestogen when needed, to help manage symptoms associated with menopause.
Systemic MHT can be highly effective for symptoms such as hot flashes and night sweats and can help prevent bone loss. Local vaginal estrogen may be used for vaginal and urinary symptoms associated with genitourinary syndrome of menopause (GSM).
The type of therapy recommended depends on your symptoms, whether you have a uterus, your health history, and your individual risks and preferences.
How Menopausal Hormone Therapy Works
Types of Menopausal Hormone Therapy
Estrogen Alone
Combined Estrogen + Progestogen
Combined Estrogen + Progestogen
Estrogen may be used alone for women who do not have a uterus.
Combined Estrogen + Progestogen
Combined Estrogen + Progestogen
Combined Estrogen + Progestogen
Women with a uterus who use systemic estrogen generally also need a progestogen to protect the uterine lining.
Local Vaginal Estrogen
Combined Estrogen + Progestogen
Other Hormone Treatments
Low-dose vaginal estrogen can target vaginal and urinary symptoms with minimal systemic absorption.
Other Hormone Treatments
Combined Estrogen + Progestogen
Other Hormone Treatments
Other hormonal treatments may be considered for specific symptoms and circumstances.
Bioidentical Hormone Therapy
“Bioidentical” describes hormones that are chemically identical to hormones produced by the human body. FDA-approved bioidentical hormone therapies include certain forms of estradiol and micronized progesterone.
The term “bioidentical” does not mean that a product is necessarily compounded. FDA-approved bioidentical hormone therapies are available in standardized formulations, while compounded bioidentical hormones are prepared by compounding pharmacies and are regulated differently.
Benefits & Considerations
Potential Benefits
Depending on the type of therapy, MHT may:
- Reduce hot flashes and night sweats
- Improve sleep when disrupted by vasomotor symptoms
- Relieve vaginal and urinary symptoms
- Help prevent bone loss and reduce fracture risk
Risks and Considerations
The risks of MHT vary according to the type of hormones used, dose, route of administration, age, health history, and timing of treatment.
Depending on the therapy and individual circumstances, considerations can include:
- Blood clots
- Stroke
- Gallbladder disease
- Breast cancer risk with some forms and durations of combined therapy
- Endometrial cancer risk when systemic estrogen is used without adequate uterine protection in a woman with a uterus
For many healthy women younger than 60 or within 10 years of menopause onset who have bothersome symptoms, the benefit-risk profile of MHT may be favorable. Treatment decisions should always be individualized.
Personalized Treatment
Finding the Right Treatment
There is no single MHT regimen that is right for everyone. Your healthcare provider can help you consider:
- Your most bothersome symptoms
- Your age and stage of menopause
- Whether you have a uterus
- Your personal and family medical history
- Whether systemic or local treatment is appropriate
- The hormone, dose, and delivery method that best fits your needs
- How your treatment should be reviewed over time
Healthy Lifestyle
Healthy habits can complement medical treatment and support long-term health during menopause.
- Eat a balanced diet rich in calcium, vitamin D, protein, fruits, and vegetables.
- Participate in regular weight-bearing and strength-training exercise.
- Prioritize good sleep and stress management.
- Avoid smoking and limit alcohol.
- Maintain a healthy weight.
Learn more about nutrition, exercise, sleep, and other healthy habits on our Healthy Lifestyle page.
Final Thoughts
Menopausal hormone therapy can be an effective option for managing symptoms and supporting certain aspects of long-term health. Understanding the different types, benefits, and potential risks can help you have a more informed conversation with your healthcare provider and decide whether MHT may be appropriate for you.
Understanding your options can help you make informed choices about menopause treatment.
Want a More Comprehensive Guide?
Looking for a complete guide to every stage of menopause? Explore Menopause Spotlight: Your Essential Guide to Perimenopause, Menopause, and Beyond.
Available in paperback, hardcover and eBook.
Medical Disclaimer
The information on this page is provided for educational purposes only and is not intended to replace professional medical advice, diagnosis, or treatment.
The benefits and risks of menopausal hormone therapy vary from person to person. Always consult your healthcare provider before starting, stopping, or changing hormone therapy or other treatments.
Seek prompt medical attention for severe or unusual symptoms or any medical emergency.