Hot flashes. Night sweats. These are the most common - or at least the most commonly talked about - symptoms of menopause. But one reality of The Change for many women is less discussed yet no less important: problems with vaginal health and sexual function.
In an effort to shed light on this chapter of women's lives, Dr. Katherine A. Guthrie, a biostatistician in the Public Health Sciences Division at Fred Hutchinson Cancer Research Center, is co-leading a $7 million grant for a multicenter clinical trial that will compare popular treatments for menopause-related vaginal symptoms ranging from dryness and atrophy (thinning and shrinking of the tissues) to itching, irritation and painful intercourse.
Specifically, the researchers will compare two common treatments - a vaginal hormonal pill (Vagifem) and an over-the-counter gel (Replens) with placebos to evaluate their effects on bothersome vaginal symptoms and decreased sexual function. The clinical trials, which will involve 300 women between the ages of 45 and 70, will be conducted via clinical trial sites at Group Health Research Institute in Seattle and the University of Minnesota in Minneapolis.
"Neither intervention is new, but this is the first adequately powered, double-blind, placebo-controlled comparative-effectiveness trial of hormonal and non-hormonal treatments for postmenopausal vaginal symptoms," Guthrie said.
Up to 40 percent of postmenopausal women have symptoms presumed to be related to vaginal atrophy, and an estimated 75 percent of these women also report vaginal dryness, Guthrie said.
"Despite the high prevalence of postmenopausal vaginal symptoms, data to guide treatment choices is extremely limited," she said.
To this end, another aim of the grant is to build a set of comprehensive, evidence-based, user-friendly and widely available multimedia resources that would give women and health providers access to the latest clinical trial results evaluating the effectiveness of treatments for vaginal atrophy. "Our goal is to facilitate informed decision-making for managing menopausal symptoms," she said.
The researchers also plan to establish a biorepository for vaginal and blood specimens to investigate the relationships of the postmenopausal vaginal microbiome, vaginal mucosal inflammation and estrogen levels with the effectiveness of treatment for vaginal atrophy.
According to Guthrie, the number of U.S. women over age 65 is expected to double by 2022 - along with the prevalence of menopause-related vaginal symptoms.
"With new therapies for male sexual dysfunction, female partners with genitourinary atrophy are more apt to need treatment for vaginal symptoms to maintain partner intimacy without pain," she said. She and her colleagues hope this study will provide the necessary information to help inform treatment decision-making.
The five-year study is co-led by Dr. Andrea LaCroix, formerly a Women's Health Initiative investigator at Fred Hutch who now directs the Women's Health Center of Excellence at the University of California, San Diego; and Dr. Susan Reed, director of the Women's Reproductive Health Research Program at the University of Washington. It represents continued funding of MsFLASH, a clinical trials network launched in 2008 by the National Institute on Aging to test various interventions for hot flashes, night sweats and other menopausal symptoms. Since its inception, Guthrie has served as the primary statistician and since 2013 as principal investigator of the Data Coordinating Center for MsFLASH, which stands for Menopause Strategies: Finding Lasting Answers for Symptoms and Health.
The initial goal of the research network was to conduct randomized trials to compare various strategies for controlling menopause-related hot flashes and night sweats. The interventions studied included low-dose estrogen, low-dose antidepressants, omega-3 fatty acid supplements, aerobic exercise and yoga.
Guthrie and colleagues found that antidepressants (escitalopram and venlafaxine) offered as much relief as low-dose estrogen for managing vasomotor symptoms, but exercise and yoga fared no better than a placebo. They also found that antidepressants, yoga and exercise helped improve mood, sleep and overall quality of life.
"Our goal from the beginning has been to provide women with the tools necessary for navigating the symptoms of menopause - and beyond," she said, "particularly non-hormonal interventions which, unlike combined hormone-replacement therapy, are not associated with an increased risk of heart disease, stroke, breast cancer and other health risks."
Fred Hutchinson Cancer Research Center