Treatment of vulvo-vaginal atrophy with hyaluronate-based gel: a randomized controlled study

BACKGROUND: The study aimed to assess the performance and safety of single-use applicators prefilled with hy-aluronic acid (HA)-based vaginal gel (Hyalo Gyn) for the treatment of vulvovaginal atrophy (VVA)-related signs and symptoms in postmenopausal women. METHODS: Eighty women were randomized, 46 to Hyalo Gyn gel and 34 to a standard treatment (water-based lubri-cant). Outcome data collected included: the proportion of subjects having a reduction >1 point in the Verbal Rating Scale (VRS) Dryness Score, VRS Global Score, vaginal pH, Vaginal Health Index, Female Sexual Function Index, Female Sexual Distress Scale-Revised, patients' global assessment, tolerability, and safety. RESULTS: Significant improvements were observed for all the assessed endpoints in both treatment groups. The per-ception of any improvement on the VRS Dryness Score was not statistically different between the treatment groups. A sensitivity analysis on the absolute change in VRS Dryness Score showed a statistically significant difference in favor of the Hyalo Gyn group at 3 months. CONCLUSIONS: A 3-month treatment with Hyalo Gyn gel is effective, safe, and well tolerated for VVA-related symp-toms in postmenopausal women.

Automated summary

The study concludes that a 3-month treatment with Hyalo Gyn gel is effective, safe, and well tolerated for vulvovaginal atrophy-related symptoms in postmenopausal women.