New Study Shows Hormone Replacement Therapy Doesn't Increase Risk of Death—Here's What Changed

A large-scale Danish study tracking over 800,000 women found that hormone replacement therapy (HRT) is not associated with an increased risk of death, even after 10 or more years of use. This finding comes as a significant shift in how doctors and patients view HRT safety, especially after decades of hesitation driven by older research that raised serious safety alarms.

What Did the Study Actually Find?

Researchers followed women born between 1950 and 1977 from age 45 until July 2023—a median follow-up of just over 14 years. Of the 876,805 women included in the analysis, about 11.9% used menopausal hormone therapy at some point, and 5.4% died during the study period. When researchers accounted for influential factors like age, education, income, and underlying health conditions such as diabetes and heart disease, they found no meaningful difference in death risk between women who used HRT and those who never did.

The study also examined specific causes of death—including heart disease, stroke, and cancer—and found no clear differences between the groups. Duration of use didn't matter either; women who used HRT for 10 or more years showed no increased mortality risk compared to shorter-term users.

Why Has HRT Been So Controversial?

The hesitation around HRT stems from a landmark 2002 study called the Women's Health Initiative (WHI), which reported increased risks of breast cancer, heart disease, stroke, and blood clots among women taking a specific combination of synthetic hormones called conjugated equine estrogens and medroxyprogesterone acetate. This finding prompted the FDA to add a black box warning—the most serious safety warning the agency issues—to hormone therapy products. For over two decades, this warning created significant barriers: doctors became reluctant to prescribe HRT, and patients feared the treatment despite their symptoms.

However, subsequent research revealed important nuances about the original WHI findings. The study population was older, with an average age of 63, and the hormones used were synthetic, not bioidentical. Younger women and those starting hormone therapy closer to menopause onset showed a different risk profile. These reassessments ultimately led the FDA to remove the black box warning, a decision that has already begun reshaping access to treatment in 2026.

What Types of Hormone Therapy Are Available Today?

Modern hormone replacement therapy has evolved significantly. Today, many providers recommend bioidentical hormones—compounds chemically identical to those naturally produced by the human body, derived from plant sources like soy or yams. These differ from the synthetic hormones used in the original WHI study, which have a different molecular structure and interact with hormone receptors differently.

One increasingly popular delivery method is hormone pellet therapy, a form of bioidentical hormone replacement therapy that uses small, rice-sized pellets inserted beneath the skin to deliver consistent doses of hormones over three to six months. The pellets, typically containing estradiol or testosterone, dissolve gradually based on cardiac output, mimicking the body's natural hormone release patterns and eliminating the peaks and troughs common with other delivery methods like creams, patches, or injections.

Who Benefits Most from Hormone Replacement Therapy?

Women in perimenopause and menopause represent the largest demographic seeking hormone therapy. As estradiol and progesterone levels decline, symptoms such as hot flashes, night sweats, vaginal dryness, bone density loss, and mood instability can significantly impact quality of life. Pellet therapy using estradiol and, in many cases, a small dose of testosterone can address these symptoms effectively.

Good candidates for hormone therapy are adults experiencing symptoms of hormonal imbalance confirmed by comprehensive bloodwork. Common symptoms include:

• Sleep and Mood Issues: Persistent fatigue, poor sleep quality, mood swings, and depression
• Cognitive and Physical Changes: Brain fog, unexplained weight gain, and muscle loss
• Sexual and Metabolic Symptoms: Low libido and other signs of hormonal decline

However, candidacy is determined on an individual basis. Patients with certain conditions—including hormone-sensitive cancers, uncontrolled blood clotting disorders, or active liver disease—may not be appropriate candidates, which is why lab testing and medical evaluation are essential before initiating treatment.

What Does the FDA Change Mean for Access to Treatment?

The removal of the black box warning has practical effects across healthcare settings. More providers are now willing to offer bioidentical hormone replacement therapy services, and more patients are pursuing treatment without the stigma and fear attached to the former warning. Medspas and wellness clinics have seen notable growth in hormone optimization services as a result. The combination of updated FDA guidance, growing patient awareness, and accessible medspa-based treatment is broadening who can benefit from hormone therapy in 2026.

Current medical guidelines now recommend hormone therapy for women who have recently begun menopause and have moderate to severe symptoms with no contraindications. This represents a significant shift from the cautious approach that dominated the past two decades.

The new Danish mortality data provides reassurance for patients and providers considering hormone therapy. While the treatment is not without risks and requires careful medical evaluation, the evidence now suggests that when appropriately prescribed and monitored, HRT does not increase the overall risk of death—a finding that may help many people make more informed decisions about managing their menopausal symptoms.