It's OK to Use Vaginal Estradiol Cream Longer Than 4 Weeks -- Here's Why

Andrew M. Kaunitz, MD


October 30, 2019

This transcript has been edited for clarity.

The European Medicines Agency's (EMA) guidance about the use of vaginal estrogen is not evidence based and will hurt women with genitourinary syndrome of menopause (GSM).

GSM is an underdiagnosed and undertreated condition; it causes vaginal dryness and pain with intercourse. GSM often progresses without treatment; symptoms tend to become bothersome years after menopause.

Although use of over-the-counter lubricants and moisturizers constitutes appropriate initial treatment for women with symptomatic GSM, low-dose vaginal estrogen, DHEA, and ospemifene address the primary pathophysiology of this condition. These prescription treatments are appropriate if lubricants and moisturizers are not effective.

In early October, the European Medicines Agency (EMA) issued a statement indicating that for safety concerns, treatment with vaginal estradiol cream be limited to a duration of not more than 4 weeks. This recommendation is not consistent with guidance from the North American Menopause Society (NAMS) or the American College of Obstetricians and Gynecologists (ACOG); both organizations, in fact, advise that low-dose vaginal estrogen may be used as long as needed, including indefinitely.

Two large, prospective US observational cohort studies of postmenopausal women provide reassurance regarding the safety of vaginal estrogen. The Women's Health Initiative study followed over 1500 women who used vaginal estrogen for a median duration of 2 years. The Nurses' Health Study followed almost 900 women using vaginal estrogen for a mean duration of 3 years. In neither of these studies was vaginal estrogen associated with an elevated risk for endometrial, breast, or colorectal cancer. Likewise, use of vaginal estrogen was not associated with an elevated risk for coronary heart disease, stroke, or venous thromboembolism.

Further reassurance on the safety of vaginal estrogen comes from a recent meta-analysis of observational studies which found no suggestion that vaginal estrogen impacts risk for breast cancer.

Although this recent warning from the EMA is not based on evidence, it will likely result in women avoiding a safe, effective, and much-needed treatment for this common condition. Untreated GSM can have a negative effect not only on women's vulvovaginal health, but also on their self-image, quality of life, and intimate relationships.

I encourage physicians to follow guidance from NAMS and ACOG, including asking about symptoms of GSM, identifying this prevalent condition during pelvic examinations, and offering effective treatment.

Thank you for the honor of your time. I am Andrew Kaunitz.

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