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

• Published in: Climacteric : the journal of the International Menopause Society Vol. 20; no. 5; pp. 467 - 475
• Main Authors: Nappi, R. E., Cagnacci, A., Becorpi, A. M., Nappi, C., Paoletti, A. M., Busacca, M., Martella, S., Bellafronte, M., Tredici, Z., Di Carlo, C., Corda, V., Vignali, M., Bagolan, M., Sardina, M.
• Format: Journal Article
• Language: English
• Published: England Taylor & Francis 01.10.2017; Taylor & Francis Ltd
• Subjects: Administration, Intravaginal; Aged; Atrophy - physiopathology; colostrum; dyspareunia; Female; Gels; Hormone replacement therapy; Humans; Menopause; Middle Aged; Postmenopause - physiology; Quality of Life; Reproductive health; Sexual Dysfunction, Physiological - epidemiology; Vagina - pathology; Vaginal atrophy; Vaginal Creams, Foams, and Jellies - adverse effects; Vaginal Creams, Foams, and Jellies - therapeutic use; Vaginal Diseases - drug therapy; vaginal dryness; vaginal gel; Womens health; dyspareunia; Vaginal atrophy; menopause; vaginal dryness; colostrum; vaginal gel
• ISSN: 1369-7137; 1473-0804
• DOI: 10.1080/13697137.2017.1335703

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