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

R. E. Nappi, A. Cagnacci, A. M. Becorpi, C. Nappi, A. M. Paoletti, M. Busacca, S. Martella, M. Bellafronte, Z. Tredici, C. Di Carlo, V. Corda, M. Vignali, M. Bagolan, M. Sardina

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)467-475
Number of pages9
JournalClimacteric
Volume20
Issue number5
DOIs
Publication statusPublished - Sep 3 2017

Keywords

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

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

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