Monurelle Biogel^® vaginal gel in the treatment of vaginal dryness in postmenopausal women

Abstract

Objectives: To evaluate efficacy, tolerability and safety of Monurelle Biogel^® vaginal gel for treatment of vaginal dryness.

Methods: Multicenter, national, randomized, controlled vs. no-treatment, open-label study. Ninety-five postmenopausal women were randomized (48 to Monurelle Biogel^® and 47 to no treatment). Primary endpoint was the change of Verbal Rating Scale (VRS) total score of vaginal atrophy (VA) symptoms after 8-week treatment. The main secondary endpoints were VRS single-item score, Vaginal Health Index (VHI) score, Maturation Index (MI), Female Sexual Function Index (FSFI), and Female Sexual Distress Scale-Revised (FSDS-R).

Results: The VRS total score was statistically significant in favor of the treatment group on day 28 (p = 0.001) but not on day 56 (p = 0.064). By excluding women who were not sexually active, the total VRS scores reached the criteria for clinical success in 27/43 subjects (62.8%) in the control arm and in 38/46 subjects (82.6%) in the treatment arm (p = 0.035) on day 56. The VHI score significantly changed in the active arm (4.71 ± 4.85 vs. 0.28 ± 1.71) (p < 0.001) on day 56. Even the MI significantly improved, with an increase in the percentage of superficial cells (p = 0.01). The improvements in both VHI and MI were still present at the follow-up visit after the discontinuation of the treatment (day 84). Sexual function and distress showed a statistical significant difference on day 56.

Conclusions: Monurelle Biogel^® vaginal gel applied twice daily for 8 weeks is effective in relieving vaginal dryness and other VA symptoms. Such a clinical meaningful effect persists at least 4 weeks and is supported by an improvement in the vaginal environment.

Trial Registration clinicaltrials.gov Identifier: NCT02994342

Keywords:

• Vaginal atrophy
• vaginal dryness
• dyspareunia
• menopause
• vaginal gel
• colostrum

Acknowledgements

The authors thank Mrs Raffaella Pampuri (Cytologic Service, Anatomic Pathology, Fondazione IRCCS Policlinico San Matteo, University of Pavia, Italy) for helpful suggestions on how to perform vaginal cytology.

Conflict of interest

During the past 2 years, Dr Nappi had financial relationship (lecturer, member of advisory boards and/or consultant) with Bayer-Schering Pharma, Endoceutics, Gedeon-Richter, HRA Pharma, Merck Sharpe & Dohme, Novo Nordisk, Pfizer Inc, Shionogi Limited, TEVA Women’s Health Inc, Zambon SpA). Other authors declare no conflict of interest.

Source of funding

This study was funded by Zambon SpA with research grants to the local institutions.