New therapies for vaginal menopause symptoms may provide short-term relief
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Key takeaways:
- Vaginal estrogen, dehydroepiandrosterone, moisturizers and oral ospemifene may improve genitourinary symptoms of menopause.
- More studies are needed to assess long-term efficacy, tolerability and safety.
Vaginal estrogen, vaginal dehydroepiandrosterone, oral ospemifene and vaginal moisturizers result in short-term improvements in vaginal atrophy symptoms, known as genitourinary syndrome of menopause, but more long-term data are needed.
“Treatments for [genitourinary syndrome of menopause] aim to relieve bothersome symptoms by mimicking or restoring premenopausal vaginal secretions and tissue integrity,” Elisheva R. Danan, MD, MPH, primary care physician in the department of medicine at the Minneapolis VA Center for Care Delivery & Outcomes Research at the University of Minnesota, and colleagues wrote in Annals of Internal Medicine. They added, “Vaginal estrogen and vaginal moisturizers have long been the mainstay of treatment, but newer non-estrogen local and systemic hormone therapies have emerged.”
Comparing new vs. older therapies
Danan and colleagues conducted a systematic review assessing 46 randomized controlled trials published through December 2023. All studies enrolled postmenopausal women with at least one genitourinary syndrome of menopause symptom lasting at least 8 weeks. All studies reported effectiveness and adverse events caused by hormonal interventions or vaginal moisturizers.
Overall, vaginal estrogen was evaluated in 22 studies, non-estrogen hormones in 16 studies, vaginal moisturizer in four studies and multiple interventions in four studies.
Vaginal estrogen, vaginal dehydroepiandrosterone and oral ospemifene (Osphena, Senshio; Shionogi) all may improve vulvovaginal dryness and dyspareunia compared with placebo or no treatment, according to researchers. Compared with placebo, vaginal estrogen may also improve the most bothersome genitourinary syndrome of menopause symptoms and both vaginal estrogen and oral ospemifene may improve treatment satisfaction. In addition, vaginal dehydroepiandrosterone may improve distress, bother or interference from genitourinary syndrome of menopause symptoms compared with placebo.
Data suggest vaginal moisturizers may only improve vulvovaginal dryness.
Researchers observed no benefit or uncertain effects on genitourinary syndrome of menopause symptoms with vaginal testosterone, systemic dehydroepiandrosterone, vaginal oxytocin and oral raloxifene or bazedoxifene treatments.
According to the researchers, though serious adverse events were uncommon, this may be due to limited reporting as included studies were short and lasted up to 12 weeks. Therefore, long-term follow-up for efficacy, tolerability and endometrial safety past 1 year is needed, the researchers noted.
“Future studies would be strengthened by standard definitions of symptoms and uniform diagnostic criteria for genitourinary syndrome of menopause, a common set of validated outcome measures and reporting standards and attention to clinically relevant patient populations and intervention comparisons,” the researchers wrote.
Longer, more diverse trials needed
In a related editorial, Stephanie S. Faubion, MD, MBA, MSCP, director of the Mayo Clinic Center for Women’s Health and medical director of The Menopause Society, noted that these findings document how “stunningly little” we know about genitourinary syndrome of menopause.
“In addition to routine adoption of the [Core Outcomes in Menopause] genitourinary syndrome of menopause outcome measures, standardization of the diagnostic criteria for genitourinary syndrome of menopause in the clinical trial setting is key,” Faubion wrote. “Further, inclusion of diverse patient populations, including those with chronic medical conditions and history of cancer; reporting of longer-term serious adverse events; and head-to-head comparisons of different therapies will advance science and ultimately improve the care of all women with [genitourinary syndrome of menopause].”