For years, the word “hormones” alone was enough to generate fear. In menopause, this has had a very concrete consequence: millions of women have continued to live with vaginal dryness, pain during intercourse, burning sensations, and urinary symptoms, considering them an inevitable price to pay for the passing of time.
Today, we know that this is not the case. And, above all, that it should no longer be so.

In recent years, scientific research has clarified a fundamental point: not all hormone therapies are the same. The recent position taken by the FDA marks a historic turning point, because it officially recognizes what the scientific community has long maintained: low-dose local hormone therapies cannot be judged using the same criteria as systemic therapies.

This is a shift in perspective that has a direct impact on women’s quality of life.

The turning point: the review of FDA warnings

In November 2025, the FDA (Food and Drug Administration) announced the start of a process to reconsider the most severe warnings (“black box warnings”) applied to estrogen-containing drugs, including low-dose vaginal ones.

These warnings, developed in a different historical and scientific context, have had a powerful side effect: they have fueled fear, often disproportionate to the real risk profile of local treatments.

As explained by Steve J. Fleischman, MD, President of ACOG, many of the listed side effects – thrombosis, stroke, cancer, dementia – are derived from data on systemic hormone therapies and are not automatically transferable to vaginal estrogens, which have minimal systemic absorption.

The result? Women with an appropriate prescription who gave up therapy, despite a potentially high benefit and very low risk.

The FDA’s decision moves in the opposite direction: less alarmism, more scientific accuracy.

Genitourinary syndrome of menopause: a real problem, not a“secondary” one

The reduction of estrogens in menopause not only affects the menstrual cycle. Estrogens are essential to maintain: the thickness and elasticity of the vaginal mucosa, proper lubrication, an acidic and protective vaginal pH, and the balance of the vaginal microbiota.

When these hormones decrease, tissues become thinner, drier, and more fragile. The pH changes, the vaginal flora is altered, and symptoms appear that we now define as genitourinary syndrome of menopause (GSM).

Persistent dryness, burning, pain during intercourse, recurrent urinary tract infections, urgency, and increased urinary frequency are not marginal complaints. They are chronic, progressive symptoms with a profound impact on quality of life, sexuality, and emotional well-being.

And, unlike hot flashes, they do not tend to resolve spontaneously.

What local hormone therapies really are

Local hormone therapies are designed to address exactly this problem.

They do not “treat menopause,” but rather treat the tissues that suffer from estrogen deficiency.

They are applied locally (ovules, capsules, vaginal creams) and use: very low-dose estrogens (estriol or estradiol) or prasterone (DHEA), a hormonal precursor that is converted directly within vaginal tissues.

The key point is this: the action is local, not systemic.

Blood hormone levels remain comparable to those of an untreated woman.

It is precisely this distinction that the FDA now recognizes with greater clarity.

Why they work (and why they are different from systemic therapy)

Vaginal estrogens promote:

·      thickening of the mucosa

·      increased elasticity

·      improved lubrication

·      restoration of a physiological vaginal pH

Prasterone, on the other hand, is converted “on demand” within vaginal cells into the hormones needed, without overloading the body.

The result is not only a reduction in pain, but an overall improvement in intimate comfort, sexual response, and perception of one’s own body.

Safety: what science says today

The main international scientific societies agree on one point: at the doses used locally, systemic absorption is minimal.

This means that the risks associated with systemic hormone therapy are not comparable to those of vaginal therapies. This is exactly the distinction that, for years, was not communicated clearly.

For most women, local hormone therapies have a favorable safety profile and can be used even long-term, with periodic monitoring.

In cases of hormone-sensitive cancers, the choice must always be personalized and shared within a multidisciplinary setting, involving the oncologist. But even in these contexts, today the debate is more balanced and data-driven.

A cultural paradigm shift, not just a therapeutic one

The revision of FDA warnings is not just a regulatory act. It is a cultural signal: women’s intimate health deserves the same scientific rigor with which cardiovascular risk or bone health are evaluated.

Ignoring genitourinary syndrome means accepting pain, renunciation, and silence. Treating it means recognizing that menopause is not an end, but a transformation that can be supported with appropriate tools.

Today we have data, targeted therapies, and greater institutional awareness.

Fear can no longer be the guiding criterion.

The FDA’s decisions represent an important step toward a more precise, more honest medicine, closer to the real lives of women.

Talking about local hormone therapies means talking about quality of life, dignity, and freedom from pain.

And this, finally, is a conversation that can emerge from silence.

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