A quick summary: Menopause Hormone Therapy, what you need to know

Menopausal hormone therapy (MHT) is the most effective treatment for hot flashes, night sweats, and vaginal symptoms related to menopause. It can also be very effective at treating many other symptoms of menopause like sleep disturbances, mood, low energy, joint pain, dry skin & nails, sexual dysfunction.

For a vast majority of women going through menopause transition, benefits generally outweigh risks when therapy is appropriately prescribed and monitored.

Things to know about modern MHT:

• MHT can still be prescribed after 60 years old when clinically appropriate
• MHT can be used as long as needed, there is no time limit
• Much of the fear around hormone therapy comes from misinterpretation of the early WHI study data, which led to two decades of under-treatment of menopause
• Transdermal estradiol and micronized progesterone have been shown to be safer options than other formulations
• The FDA has removed the outdated “Black Box warning” on estrogen therapy, although it still remains on packaging in Canada.
• Vaginal estrogen is safe for most women
• Vaginal estrogen can be taken without progesterone
• MHT can be prescribed to prevent bone loss
• Modern MHT prescriptions do not increase the risk of cardiovascular diseases, stroke or breast cancer

The bottom line: There is no single way to experience menopause, and there is no one-size-fits-all treatment.

• When chosen wisely and monitored properly, MHT is safe, effective, and can be a game-changing for your quality of life
• At Coral, we believe in a personalized approach that is grounded in science and deeply human

The full scoop: Menopause Hormone Therapy, what you need to know

WHEN and WHY is menopause hormone Therapy (MHT) prescribed?

Menopausal hormone therapy (MHT) may be prescribed to support women through the menopause transition when hormonal changes are affecting health or quality of life. MHT can be used to:

• Relieve various symptoms related to hormonal changes during menopause transition
• Improve quality of life when symptoms are impactful
• Treat genitourinary syndrome of menopause (GUSM), including vaginal dryness, discomfort with sex, and urinary issues
• Help prevent osteoporosis (bone loss)
• Support women with early menopause (before 45 years old) whether medically induced or natural

Is MHT safe?

For most women who start MHT before age 60 or within 10 years of menopause, MHT is safe and is the most effective treatment for menopause symptoms. It can be life-changing when appropriately prescribed.

For women over the age of 60 or more than 10 years beyond menopause who have never used hormone treatment, MHT can still be prescribed safely. In these cases, treatment decisions are made following a comprehensive health and quality-of-life assessment with close follow-up and monitoring.

For two decades, fears around hormone therapy were driven by misinterpretation of early research data from the Women’s Health Initiative (WHI). We now have a clearer understanding of who benefits from MHT, who should avoid it, and how to prescribe it safely, including the distinctions between the various types of MHT available for prescription.

Why the WHI study was misleading and its impact on women’s well-being

The original WHI study was a randomised control trial, but it was not designed to answer the question most women are asking today: “Is it safe and effective to start hormone therapy for symptomatic women going through the menopause transition?”

Instead, the WHI aimed to answer a different question: “Should we prescribe HRT to women to prevent heart disease and other chronic conditions?”

In order to answer that question, the study included:

• Older women (average age of 62-63yo)
• Only women WITHOUT menopause symptoms
• One type of hormone therapy: Non-body-identical oral conjugated equine estrogen (CEE), with or without medroxyprogesterone acetate (MPA) a synthetic progestin

Additional limitations of the WHI:

• Most participants were over 10–20 years past menopause
• Many had existing cardiovascular risk factors
• Results were broadly applied to all women, regardless of age or timing of prescription

Later analyses showed that age and timing matter greatly. When hormone therapy is initiated closer to the menopause transition, the balance of benefits and risks is far more favourable.

Following the abrupt discontinuation of the WHI study in 2002 and its misrepresentation by the media, prescriptions for MHT declined drastically, from 75-80% to less than 5%. As a result, most women not only stopped receiving MHT prescriptions but also ceased to receive proper comprehensive menopause care.

Understanding the “Black Box Warning” on your prescription

Following the WHI study, MHT products were given a “Black Box Warning” highlighting risks of breast cancer, heart disease, stroke, and dementia. These warnings originated from early interpretations of the WHI study and are now considered inaccurate based on updated evidence on MHT. Consequently, they do not reflect current evidence and best practices in modern menopause care.

Importantly, the warnings don’t distinguish between different types of hormone therapy, age, timing of initiation, route of administration, or dose, and also don’t apply to low-dose vaginal estrogen. As a result, many women experienced unnecessary fear and under-treatment for more than two decades.

In 2025 the U.S.  FDA initiated the removal of the “Black Box Warning” from estrogen-containing menopausal hormone therapies to better align with current scientific consensus. Because Health Canada has not yet taken similar action, warnings regarding hormone treatments will continue to appear, even in cases where they are not relevant to the majority of patients.

Today’s evidence on MHT

Current research demonstrates that:

• Benefits of MHT generally and significantly outweigh risks
• MHT is the most effective treatment for vasomotor symptoms (such a hot flashes and night sweats) during menopause transition
• MHT can also improve sleep, mood, and overall quality of life
• MHT helps prevent bone loss and fractures [1][2]
• MHT reduce the risk of developing type 2 diabetes [1]
• MHT does not increase the risk of heart disease
• There is no increase in all-cause mortality among women using MHT
• Transdermal (skin-based) estrogen does not appear to increase the risk of stroke or deep vein thrombosis (DVT)
• Current vaginal (local) estrogen treatments are low dose and don’t raise systemic estrogen levels, making them safe and effective for most women for the treatment of GUSM, including for women with a history of breast cancer.

Although there is promising evidence, the current official guidelines do not support the use of MHT solely for prevention of:

• Alzheimer’s or dementia
• Breast cancer
• Type 2 diabetes
• Stroke
• Depression
• Aging

Breast cancer risk and MHT

Breast cancer risk depends on several factors, including the type of hormone used, duration of therapy, and an individual’s baseline risk.

In the WHI study, only the group of women receiving MPA, a synthetic progestin, had a slight increase in breast cancer rate. In contrast, micronized progesterone does not appear to carry the same risk based on other studies.

Women in the WHI study receiving only estrogen therapy (without the MPA progestin, because they did not have a uterus) had a lower rate of breast cancer. Current evidence on estrogen-only therapy shows no increased risk of invasive breast cancer and a reduction in  breast cancer mortality.

Bioidentical hormones – commonly named bMHT or body-identical

Bioidentical hormones are chemically identical to those produced by the human body, such as estradiol (E2) and micronized progesterone (P4). These hormones are available as FDA-approved and Health Canada-approved, regulated medications. Although often described as “natural”, these products are still manufactured medications (synthetic).

While compounded therapies are also often described as bioidentical, they are generally not recommended as a first-line treatment. Compounded bioidentical hormone therapies are not regulated and analysed by regulatory authorities for safety, efficacy, potency, or quality, which can result in variability in dosing, absorption, and purity. In addition, there is a lack of high-quality clinical evidence showing that compounded hormones are safer or more effective than approved therapies, and adverse events are not systematically monitored or reported. Compounded hormone therapy may be considered in specific situations (such as allergies,medication shortages, or cost barriers) but require close monitoring. Similar caution applies to phytoestrogens, which are also unregulated.

Unfortunately, in most Canadian provinces, public healthcare plans do not cover regulated and approved bioidentical hormone therapy.

The bottom line

Treatment using MHT must always be individualized, evidence-based, and regularly reassessed. When appropriately prescribed and monitored, MHT is safe, effective, and can significantly improve quality of life.

Disclaimer: The information provided here is for informational purposes only. It is not intended as medical advice. Always consult with your doctor or healthcare provider to determine what is best for your individual health needs.

References:

[1] https://jamanetwork.com/journals/jama/fullarticle/2797868 Gartlehner G, Patel SV, Reddy S, Rains C, Schwimmer M, Kahwati L. Hormone Therapy for the Primary Prevention of Chronic Conditions in Postmenopausal Persons: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2022;328(17):1747–1765. doi:10.1001/jama.2022.18324

[2] Rozenberg S, Al-Daghri N, Aubertin-Leheudre M, Brandi ML, Cano A, Collins P, Cooper C, Genazzani AR, Hillard T, Kanis JA, Kaufman JM, Lambrinoudaki I, Laslop A, McCloskey E, Palacios S, Prieto-Alhambra D, Reginster JY, Rizzoli R, Rosano G, Trémollieres F, Harvey NC. Is there a role for menopausal hormone therapy in the management of postmenopausal osteoporosis? Osteoporos Int. 2020 Dec;31(12):2271-2286. doi: 10.1007/s00198-020-05497-8. Epub 2020 Jul 8. PMID: 32642851; PMCID: PMC7661391

[3] Manson JE, Crandall CJ, Rossouw JE, et al. The Women’s Health Initiative Randomized Trials and Clinical Practice: A Review. JAMA. 2024;331(20):1748–1760. doi:10.1001/jama.2024.6542