Results of a small study of ospemifene provide direct evidence of the effect of the drug on vaginal tissue, according to the authors. The findings show efficacy that extends to the vulvar vestibule, they said, noting that they need to be confirmed by a longitudinal study.
Published in The Journal of Sexual Medicine, the research was designed to evaluate changes induced by ospemifene on epithelium thickness, glycogen content proliferation index, collagen content, and type I/III collagen ratio in vulvar and vaginal tissue. Twenty postmenopausal women at a gynecologic clinic who were scheduled for surgery were enrolled in the study. Eleven of the participants were taking ospemifene at the time of inclusion; the other nine women were the control group.
The authors took vaginal and vulvar biopsies from the women during surgery. The histological features and glycogen content of the biopsies were evaluated by standard hematoxylin-eosin and periodic acid-Schiff staining. Total collagen and collagen type I/III ratio were evaluated with hydroxyproline assay and Sirius red staining. Immunohistochemistry was used to evaluate Ki67 expression.
The researchers found that in the women taking ospemifene, epithelial thickness, glycogen content, and proliferation index were increased compared with the control group. The women on the drug also had more collagen in their biopsies, while an increased ratio between type I and III collagen fibers was found only at the vaginal level.
The authors concluded that ospemifene intake is associated with a marked improvement in various morphological and physiological features of both vaginal and vulvar vestibule epithelium, including collagen content of tissues.