Clinicians caring for menopausal women are familiar with the genitourinary syndrome of menopause (GSM), previously referred to as vulvovaginal atrophy, a progressive condition that impairs sexual function and quality of life. Although GSM affects up to 45% of midlife and older women, most with the condition go undiagnosed and untreated.1
Estrogen represents a key regulator of vaginal physiology. Declines in estrogen associated with menopause play a central role in the pathophysiology of GSM. The occurrence of symptomatic GSM in premenopausal women with hypoestrogenemic states, including lactation and use of GnRH agonists, underscores the central role estrogen plays in maintaining normal vaginal function.
Over-the-counter (OTC) vaginal lubricants used with sexual activity and vaginal moisturizers used on a routine basis several times per week can provide some relief from symptoms of GSM.1
In March 2018, a report published in JAMA Internal Medicine described results of an NIH-funded, short-term (3 mo), double-blind trial that randomized women with symptoms suggestive of GSM to these three groups: 1) Currently marketed 10 µg estradiol tablets plus placebo vaginal gel, 2) Placebo vaginal tablets plus a currently marketed vaginal moisturizer gel, or 3) Placebo tablets plus placebo gel.2 The trial’s primary outcome related to reported severity of participants’ most bothersome symptom (MBS), which was defined at enrollment.
In the 302 women randomized, pain with penetration represented the most common MBS (reported by 69% of participants), followed by dryness (21%). A small reduction in MBS was observed with all treatments. Neither vaginal estradiol tablets nor the commercially marketed moisturizer reduced the MBS more than placebo gel. Likewise, participants reported an improvement in sexual function that was similar in those randomized to estradiol versus placebo gel as well as those randomized to moisturizer versus placebo gel.