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Vaginal estradiol tablets improve sexual function vs. moisturizer
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Menopausal women with moderate to severe vulvovaginal symptoms assigned vaginal estradiol tablets plus a placebo moisturizer for 12 weeks reported a greater improvement in sexual function and menopause-related quality of life vs. similar women assigned vaginal moisturizer plus placebo or double placebo, according to findings from a three-arm, double-blind trial.
Bothersome vulvovaginal symptoms such as a lack of lubrication and discomfort or pain with vaginal intercourse are reported by nearly 75% and 40% of postmenopausal women, respectively, Susan J. Diem, MD, MPH, of the department of medicine and epidemiology and community health at the University of Minnesota in Minneapolis, and colleagues wrote in the study background. Moderate to severe vulvovaginal symptoms in postmenopausal women are associated with decreases in sexual functioning and quality of life comparable to other chronic conditions, the researchers noted.
“Randomized, double-blind, placebo-controlled trials have demonstrated that vaginal estrogen creams, vaginal estrogen tablets, intravaginal prasterone and ospemifene reduce vulvovaginal symptoms, although few trials have examined the effects of treatment on [quality of life] or mood,” Diem and colleagues wrote. “Limited data exist to support the use of vaginal moisturizers, and no studies have examined their effects on [quality of life].”
Diem and colleagues analyzed data from 302 postmenopausal women reporting moderate to severe vulvovaginal symptoms, recruited from Kaiser Permanente Washington Health Research Institute in Seattle and the University of Minnesota in Minneapolis between April 2016 and February 2017 (mean age, 61 years; 88% white; 85% married or partnered; 81% sexually active). Researchers randomly assigned women to 10 µg vaginal estradiol (Vagifem, Novo Nordisk) plus placebo vaginal gel (hydroxyethyl cellulose; n = 102), placebo vaginal tablet plus vaginal moisturizer (Replens; n = 100) or dual placebo (n = 100) for 12 weeks. Women were instructed to use the vaginal tablet daily for 2 weeks (tablet in the morning and gel in the evening), and then twice weekly for 10 weeks. The vaginal gel (active or placebo) was to be used every 3 days through the trial. Follow-up visits occurred at 4 and 12 weeks, with women completing the 29-item Menopause-Specific Quality of Life (MENQOL) questionnaire (average domain scores range from 1 to 8, with higher score indicating poorer quality of life), the eight-item version of the depression module of the Patient Health Questionnaire (scores range from 0 to 24; score of 10 or more considered moderate to severe depression) and the seven-item Generalized Anxiety Disorder questionnaire (scores range from 0 to 21; score of 10 or more considered severe anxiety).
Within the cohort, mean total MENQOL score was 3.3, 23.3% of women had mild depressive symptoms, 6% had moderate to severe depressive symptoms, 23.3% had mild anxiety and 9.3% had moderate anxiety.
In all treatment arms, total MENQOL scores improved over 12 weeks, according to researchers; however, women assigned vaginal estradiol tablets plus placebo gel reported a greater improvement in total MENQOL score vs. women assigned to dual placebo (mean difference between groups at 12 weeks, –0.3; 95% CI, –0.5 to 0), whereas women assigned vaginal moisturizer plus placebo tablet did not (mean difference between groups at 12 weeks, 0.2; 95% CI, –0.1 to 0.4).
Women assigned to estradiol tablets also reported a greater improvement in the sexual function domain of the MENQOL questionnaire (mean difference at 12 weeks, –0.4; 95% CI, –1 to 0.1), whereas women assigned to vaginal gel or dual placebo did not, according to researchers. There were no observed interactions between treatment assignment and selected characteristics, including the presence or absence of sexual function-related bothersome symptoms on total MENQOL score or the MENQOL sexual function domain score.
There were no between-group differences observed for changes in depression or anxiety scores over 12 weeks, according to researchers.
“These results suggest that there may be modest benefit of treatment with vaginal estradiol tablets for improving aspects of sexual function captured in the MENQOL,” the researchers wrote. “Other considerations such as cost, ease of obtaining treatment and personal preferences regarding vaginal treatment options may influence individual therapeutic choices.” – by Regina Schaffer
Disclosure: The NIH National Institute on Aging funded this study.
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