Should We Rethink Our Use of Vaginal Estrogen?

Andrew M. Kaunitz, MD


April 02, 2018

Hello. I am Andrew Kaunitz, professor and associate chair in the Department of Obstetrics and Gynecology at the University of Florida College of Medicine in Jacksonville. Today I'd like to ask: Should we rethink our use of vaginal estrogen?

Genitourinary syndrome of menopause (GSM), previously called vulvovaginal atrophy, represents a common progressive condition that impairs sexual function and quality of life.

Declines in estrogen associated with menopause play a key role in the pathophysiology of GSM.

Over-the-counter vaginal lubricants, which are used with sexual activity, and moisturizers, which are used on a routine basis, can provide some relief from symptoms of GSM.

A National Institutes of Health–funded 3-month double-blind trial[1] randomized women with symptoms suggestive of GSM to three groups, each of which included use of a vaginal tablet and gel:

  1. Currently marketed estradiol tablets plus placebo vaginal gel;

  2. Placebo vaginal tablets plus a currently marketed vaginal moisturizer gel; or

  3. Placebo tablets plus placebo gel.

Severity of participants' most bothersome symptom (MBS), defined at enrollment, represented the primary outcome.

Among the over 300 women randomized, the most common MBS was pain with penetration, followed by dryness. A small reduction in MBS was observed with all treatments. Likewise, participants reported an improvement in sexual function which was similar among those randomized to estradiol versus placebo as well as those randomized to moisturizer versus placebo.

As the investigators noted, their trial differs from others in that they employed gel placebo rather than placebo cream or tablets. The use of gel placebo may help explain the substantial placebo response noted with this trial.

One takeaway message from this study, and one consistent with current guidance from the North American Menopause Society,[2] is that use of lubricants and moisturizers is an appropriate first step for women with symptomatic GSM. On the basis of the findings of this short-term trial, some clinicians and women will conclude that use of vaginal estrogen which, after all, is often expensive and mired in controversies surrounding hormone therapy, should be abandoned. However, my perspective is different.

Multiyear clinical trials assessing treatment of GSM have not been performed. However, our understanding of this common condition's genesis underscores the key role played by estrogen. Numerous 1-year published trials of women with symptomatic GSM have consistently demonstrated vaginal estrogen's safety as well as its superiority to placebo in managing symptoms. Over the long run, and consistent with NAMS guidance,[2] outcomes for our patients with symptomatic GSM not adequately managed with over-the-counter products will be optimized if treatment includes vaginal estrogen.

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


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