Abstract


Stefania Alvisi1, Maurizio Baldassarre2, Valentina Martelli1, Giulia Gava1, Ilaria Mancini1 and Maria Cristina Meriggiola*1
1University of Bologna and S. Orsola-Malpighi Hospital, Bologna, Italy, 2University of Bologna and S. Orsola - Malpighi Hospital, Bologna, Italy

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Stefania Alvisi1, Maurizio Baldassarre2, Valentina Martelli1, Giulia Gava1, Ilaria Mancini1 and Maria Cristina Meriggiola*1
1University of Bologna and S. Orsola-Malpighi Hospital, Bologna, Italy, 2University of Bologna and S. Orsola - Malpighi Hospital, Bologna, Italy

Introduction:Ospemifene is a selective estrogen receptor modulator (SERM) approved in Europe for the treatment of moderate to severe vulvo-vaginal atrophy in post-menopausal women. Although both preclinical and clinical studies have demonstrated its efficacy, no direct evidences of the effects of Ospemifene on the human vagina have been reported.

Aims: To evaluate the effect of Ospemifene on epithelium thickness, glycogen content, proliferation index and estrogen receptor alpha (ERα) expression of the vaginal tissue of post-menopausal women.

Methods: Thirty-two post-menopausal women admitted to the Gynecological Unit of our Institution for scheduled surgical procedures were enrolled. Sixteen subjects currently taking Ospemifene (Osp group) at the time of inclusion in the study and sixteen control subjects (Ctrl group) not taking any drugs were included in the study. Anthropometric and clinical parameters were recorded at study inclusion. Vaginal biopsies were taken from the proximal and distal vaginal wall during surgery. Histological features and glycogen content were evaluated in each biopsy by standard hematoxylin-eosin and periodic acid-Schiff staining respectively. Expression of Ki67 and ERα were evaluated by immunohistochemistry.

Results: Median time of Ospemifene intake was 41 days (min. 28 – max. 77 days). Women in the Osp and Ctr groups did not differ for anthropometric parameters nor for years of amenorrhea. The analysis of vaginal biopsies showed an increased vaginal epithelium thickness in the Osp group when compared to the Ctr group (349±64 vs 245±52 µm, p=0.001) and this difference was seen also when both proximal (p=0.012) or distal (p=0.001) vagina were analyzed. In addition increased glycogen content was observed in the Osp group when compared to the Ctrl group. In the Osp group, the increased epithelium thickness was accompanied by a significant increase of the proliferation index expressed as number of Ki-67 immunoreactive cells per mm of vaginal epithelium (212±47 vs 127±28 immunoreactive nuclei/mm, p=0.001) with no differences between proximal and distal vagina. Finally women in the Osp group were characterized by a significantly increased expression of ERα, both in the epithelial (27±3 vs 21±3 score, p=0.001) and stromal (27±5 vs 21±2 score, p=0.001) layers of the proximal and distal vaginal wall.

Conclusions: Our results demonstrate that six weeks of Ospemifene intake was associated with significant changes of vaginal tissue morphology that may, in part, explain the improvement of vulvo-vaginal atrophy related symptoms reported with this SERM.

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