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%).