If you have been told that what you are experiencing is “just part of getting older,” or that your symptoms are “normal” and there is nothing to be done, you are not alone.
Genitourinary Syndrome of Menopause (GSM) includes vaginal dryness, burning, irritation, pain with intercourse, and recurrent urinary tract infections, all driven by estrogen deficiency affecting the vaginal, vulvar, and urethral tissues. GSM is extremely common, significantly undertreated, and highly responsive to therapy.
For women whose symptoms are primarily vaginal dryness, painful intercourse, or recurrent UTIs without significant systemic symptoms, local vaginal estrogen therapy is often all that is needed. This is a safe, well tolerated, first line treatment that can be prescribed in primary care, and many of the women we see have never been offered it despite years of symptoms.
Yes, low dose vaginal estrogen is considered safe for the large majority of women, and the concern you are describing comes from research that studied something different from what we prescribe.
The fear traces back to the Women’s Health Initiative, a study published in the early 2000s that examined a specific oral hormone regimen taken by women who were on average well past menopause. The findings from that single trial were applied broadly to every estrogen product regardless of dose or route of delivery. Millions of women and a great many physicians backed away from treatment as a result.
Vaginal estrogen is a fundamentally different medication. It is delivered directly to the tissue that needs it, at a dose small enough that very little enters the bloodstream. Pooled analysis of the randomized trials has not shown an increased risk of endometrial or breast cancer with local vaginal therapy. Recent data also indicate that women with a prior stroke who use vaginal estrogen tablets are not more likely to have a second stroke than women who do not.
Regulators have now formally acknowledged this distinction. In November 2025, the FDA announced it would remove the boxed warning from estrogen products, including low dose vaginal preparations, on the grounds that the warning overstated risk and was not supported by current evidence. The American Urological Association and The Menopause Society both supported that change. Removing the warning does not represent a new discovery so much as the label finally catching up to what the evidence has shown for years.
There remain situations that call for individual discussion, including a personal history of breast or endometrial cancer, unexplained vaginal bleeding, or active liver disease. A history of hormone sensitive cancer is not an automatic disqualification, and we frequently treat these women in coordination with their oncologist. Unexplained bleeding does need to be evaluated before starting any hormone therapy.
Our goal is to make this decision with you rather than for you. If you have been avoiding treatment because of what you read on a package insert, that is worth a conversation.
Ready to Talk About GSM?
Our team is ready to answer your questions and schedule your consultation.