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Minerva Obstetrics and Gynecology 2021 Jun 07

DOI: 10.23736/S2724-606X.21.04841-7


language: English

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

Rossella E. NAPPI 1, 2 , Miroslav KOTEK 3, Alexander BREŠT’ANSKÝ 4, Nicola GIORDAN 5, Irene BERIOTTO 5, Elisa TRAMENTOZZI 5

1 Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS S. Matteo Foundation, Pavia, Italy; 2 Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy; 3 ULMUS, s.r.o., Hlohovec, Slovakia; 4 Gynkomed s.r.o., Bratislava, Slovakia; 5 Fidia Farmaceutici, S.p.A., Abano Terme, Padua, Italy

BACKGROUND: The study aimed to assess the performance and safety of single-use applicators prefilled with hyaluronic 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 lubricant). 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 (VHI), Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS-R), patients’ global assessment, tolerability, and safety.
RESULTS: Significant improvements were observed for all the assessed endpoints in both treatment groups. The perception 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 symptoms in post-menopausal women.

KEY WORDS: Vulvovaginal atrophy; Hyaluronic acid; Vaginal moisturizer; Menopause; Vaginal dryness

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