Estrogen tablets and a popular vaginal gel failed to top placebo for relieving vulvovaginal symptoms in postmenopausal women, based on data from a randomized trial of more than 300 patients suffering from genitourinary syndrome of menopause (GSM), a constellation of symptoms including pain on vaginal penetration and vaginal dryness.

“Surveys of postmenopausal women demonstrate a preference for effective, nonhormonal therapies, often due to safety concerns,” wrote Caroline M. Mitchell, MD, of Massachusetts General Hospital, Boston, and her colleagues. The report was published in JAMA Internal Medicine . The researchers randomized 302 postmenopausal women with GSM 1:1:1 to a Vagifem 10-microgram estradiol tablet and placebo gel, a placebo tablet and Replens gel, or a placebo tablet and a placebo gel.

The average age of the women was 61 years, 88% were white, and 81% were sexually active.

The primary outcome was a decrease in the most bothersome symptoms reported by the women after 12 weeks of treatment. The most common of these were pain on penetration (60%) and vulvovaginal dryness (21%).

After 12 weeks, the women reported no significant difference in most bothersome symptoms between estradiol or moisturizing gel, compared with placebo products (P = .25 and P = .31, respectively). The average improvement in symptom scores was similar between the estradiol tablet and placebo tablet (P = .64) and between the moisturizer and placebo gels (P = .17).

The study was limited by several factors including the homogenous population and the absence of a head-to-head comparison of treatments, the researchers noted. However, the results suggest that more research is needed about genitourinary syndrome of menopause, but that a nonprescription lubricating gel may be an appropriate estrogen-free choice, and that “treatment choice should be based on individual patient preferences regarding cost and formulation,” they said.

The study was funded by the National Institutes of Health/National Institute on Aging. Dr. Mitchell is a consultant for Symbiomix Therapeutics, and coauthors reported grant support from Bayer and having served on a scientific advisory board for Sermonix.

SOURCE: Mitchell C et al. JAMA Intern Med. 2018 Mar. doi: 10.1001/jamainternmed.2018.0116 .


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