Hormone therapy is becoming the new standard of care.

In July 2002, the Women's Health Initiative (WHI) abruptly halted its hormone therapy arm. Within 24 hours, the headlines were everywhere: hormones cause breast cancer, heart attacks, strokes, dementia. Prescriptions dropped by more than 70% almost overnight. An entire generation of women was told their symptoms were something to "tough out."

We now know the conclusions drawn from that trial were, at best, an oversimplification — and at worst, deeply misleading.

• The wrong patients. The average WHI participant was 63 years old and more than a decade past menopause — not the 45–55-year-old women hormone therapy actually treats.
• The wrong hormones. Conjugated equine estrogens (Premarin) and synthetic medroxyprogesterone acetate (Provera) are not the bioidentical estradiol and micronized progesterone used today. They behave very differently in the body.
• A one-size-fits-all route. The trial used oral conjugated estrogens for every participant. Today, route is individualized: oral estradiol remains a safe, effective option for many women, while transdermal delivery — patches, creams, pellets — bypasses first-pass liver metabolism and is often preferred for patients with specific clotting or metabolic considerations. Tailoring the route to the patient is part of what makes modern hormone therapy fundamentally different from the WHI protocol.
• The wrong framing. The "increased risk" of breast cancer was a relative risk of less than one additional case per 1,000 women per year — smaller than the risk attributed to a glass of wine a day.

On November 10, 2025, the U.S. Department of Health and Human Services and the FDA announced the removal of the long-standing boxed warnings from menopausal hormone therapy products, including systemic estrogen and estrogen-progestin therapies. Officials cited that the warnings — written based on the original WHI interpretation — were misleading and were discouraging women from a treatment that, for the right patient, is both safe and protective. Earlier in 2025, the FDA had already moved to lift the boxed warning from low-dose vaginal estrogen, which never had evidence to support it.

Men got their own correction first. On February 28, 2025, the FDA issued class-wide labeling changes for all testosterone products, removing the cardiovascular boxed warning following the results of the TRAVERSE trial, which demonstrated that testosterone therapy in hypogonadal men is non-inferior to placebo for major adverse cardiac events.

The message from regulators is finally catching up to the literature: the warning labels written a generation ago no longer reflect what modern hormone therapy actually does.

The TRAVERSE trial — the largest cardiovascular safety study of testosterone therapy ever conducted — found that testosterone replacement in hypogonadal men did not increase the risk of heart attack, stroke, or cardiovascular death. It also reduced fractures and improved sexual function, mood, and energy. The narrative that testosterone is dangerous for the heart is, like the WHI narrative, no longer supported by the evidence.

Hormone therapy is no longer a last-resort intervention for severe symptoms. Properly prescribed — with bioidentical hormones, the right route, and the right timing — it is one of the most powerful preventive tools we have for cardiovascular disease, cognitive decline, osteoporosis, and the slow erosion of vitality that defines so much of midlife.

The standard of care is shifting. Our practice has been built around what the evidence actually says — not what a 24-year-old press release said it said.