Ospemifene, hormone therapy may improve postmenopausal vulvovaginal atrophy

Among postmenopausal women with vulvovaginal atrophy, ospemifene treatment and hormone therapy improved the vaginal microbiome in different ways, according to findings published in Menopause.

“The onset of [vulvovaginal atrophy] is mainly associated with marked reduction in circulating estrogen levels, which leads to thinning of the vaginal epithelium, less vascularization and less lubrication of the vagina,” Stefania Alvisi, MD, of the IRCCS Azienda Ospedaliero Universitaria di Bologna in Italy, and colleagues wrote. “These modifications lead to symptoms such as vaginal dryness and superficial dyspareunia, which can be associated with itching, burning sensations, susceptibility to mechanical insults, leukorrhea or atypical secretions.”

Depending on the severity of symptoms, treatments such as vaginal lubricants and moisturizers may provide relief, according to Alvisi and colleagues. The researchers aimed to evaluate the impact of two prescription treatments — ospemifene (Osphena, Shionogi Pharma) and hormone therapy — on the vaginal microbiomes of women with vulvovaginal atrophy.

The researchers enrolled postmenopausal white women who attended the Gynecology and Physiopathology of Human Reproduction outpatient clinic at the IRCCS Azienda Ospedaliero Universitaria di Bologna between April 2019 and February 2020. Those with a diagnosis of vulvovaginal atrophy were prescribed ospemifene (n = 20) or hormone therapy (n = 19). The remaining 28 women were healthy controls.

For each participant, Alvisi and colleagues collected a vaginal swab and calculated the vaginal health index (VHI) score at baseline. Those with vulvovaginal atrophy provided a second swab after 3 months of treatment. Swabs were used for vaginal maturation index (VMI) calculations.

Compared with the control group, women with vulvovaginal atrophy had greater biodiversity in their vaginal microbiomes. Women with vulvovaginal atrophy had less Lactobacillus (P = .002) and more Streptococcus (P = .008) and Sneathia (P = .02) compared with healthy controls. Greater Lactobacillus presence was associated with higher — and therefore better — scores for VHI (P = .002) and VMI (P = .035).

At 3 months, hormone therapy was associated with lower levels of bacteria in the Mycoplasmoidaceae (P = .042), Moraxellaceae (P = .022) and Burkholderiaceae (P = .046) families. There were also reductions in the genera Lachnospira (P = .041), Acinetobacter (P = .019) and Achromobacter (P = .046) and in the species Prevotella disiens (P = .031) and Ureaplasma parvum (P = .017).

In the ospemifene group, there were reductions in the Staphylococcaceae (P = .049) and Clostridiaceae (P = .015) families and the genera Staphylococcus (P = .049) and Clostridium (P = .015) at 3 months. There were no significant differences among species.

“This small study shows that both systemic hormone therapy and ospemifene improve signs of vulvovaginal atrophy and induce favorable changes in the vaginal microbiome, with differing effects on vaginal bacterial composition,” Stephanie Faubion, MD, MBA, medical director of NAMS and a Healio Women’s Health & OB/GYN Peer Perspective Board Member, said in a press release. “Areas for future study include the assessment of changes in the vaginal microbiome, proteomic profiles, and immunologic markers with various treatments and the associations between these changes and genitourinary symptoms.”

References:

• Alvisi S, et al. Menopause. 2023;doi:10.1097/GME.0000000000002150.
• Could altering vaginal microbiome treat vaginal dryness and painful sex during menopause? www.menopause.org/docs/default-source/press-release/ospemifene-impact-on-vaginal-mirobiome.pdf. Published Jan. 25, 2023. Accessed Jan. 26, 2023.