Effects of ospemifene on vaginal epithelium of post-menopausal women

Ospemifene is a selective estrogen receptor modulator used for the treatment of vulvo-vaginal atrophy (VVA) in post-menopausal women. No direct evidence of its effects on histological features of the human vagina has been reported. To evaluate the effects of ospemifene on histological parameters, glycogen content, proliferation, and estrogen receptor α expression (ERα) of vaginal epithelium in post-menopausal women. Thirty-two post-menopausal women undergoing surgical procedures were enrolled. Sixteen subjects taking ospemifene at the time of inclusion (OSP) were compared to 16 subjects not taking any hormone (CTL). Vaginal biopsies were taken from the proximal and distal vaginal wall during surgery to evaluate histology, Ki-67 and ERα expression. OSP group showed thicker vaginal epithelium (349 ± 64 vs. 245 ± 53 μm, <i>p</i> + cells/mm, <i>p</i> p p