Researchers at the University of Colorado Anschutz have developed a promising nonhormonal therapy for women experiencing Genitourinary Syndrome of Menopause (GSM). GSM is a common chronic condition caused by declining estrogen levels that affects the vulva, vagina and urinary tract, leading to symptoms such as vaginal dryness, painful intercourse, and recurrent vaginal and urinary tract infections.
Unlike over-the-counter treatments that may provide some temporary symptom relief, the new therapy is designed to restore estrogen signaling only within vaginal tissue, without exposing the rest of the body to estrogen.
In a preclinical animal study, the treatment restored the structure and function of vaginal tissue lost through estrogen deficiency, suggesting a potential way to address the underlying cause of GSM rather than simply managing its symptoms.
The findings were published today in Menopause.
“For too many women, the current options are either products that only provide temporary relief or hormone-based treatments they may not feel comfortable using,” said the paper’s senior author Steve Nordeen, PhD, professor emeritus, department of pathology at the CU Anschutz School of Medicine.
An estimated 50% to 70% of women experiencing natural or medically induced menopause develop one or more symptoms of GSM.
Currently, these women often have to choose between living with painful symptoms, using over-the-counter products that have limited efficacy or taking hormonal therapies that replace estrogen. However, many women either cannot or choose not to use hormone therapy because of concerns about potential risks, particularly those with a history of breast cancer or who have an increased risk of hormone-sensitive cancers.
“Our goal was to develop a therapy that addresses the underlying cause of the vaginal changes that follow menopause, not just the symptoms, without relying on steroid hormones. While more research is needed, these findings suggest we may have a promising new approach,” Nordeen added.
To develop this therapy, Nordeen and his colleagues synthesized a novel nonsteroidal estrogen-signaling molecule called 3-fluoro 6,4'-dihydroxyflavone (3F). Delivered as a vaginal suppository, the therapy regenerated the vaginal epithelium, the cellular lining of the vagina, in a preclinical model of menopause without evidence of systemic estrogenic activity.
“Our findings suggest the prospect of a safer and more effective therapy is within reach,” said Nordeen. “The next step is securing the support needed to move this therapy into human clinical trials so we can determine whether it offers women a new treatment option.”
The researchers suggest that if future clinical trials confirm these findings, the therapy could provide a new option for millions of women who experience GSM.