Polycarbophil vaginal moisturizing gel versus hyaluronic acid gel in women affected by vaginal dryness in late menopausal transition: A prospective randomized trial

Objectives: During menopausal transition, women are frequently affected by vulvovaginal atrophy (WA), due to the decline of estrogen levels. Resulting symptoms are itching, burning, dyspareunia, and vaginal dryness (reported in up to 85%). The aim of this trial was to verify if medical device polycarbophil vaginal (PCV) moisturizer gel is not less effective than hyaluronic acid (HA) gel in treating vaginal dryness. Material and methods: This was a multicenter, open label, randomized, parallel group, comparative study with non-inferiority design. Female included were >= 45 to <= 55 years in the menopausal transition, with subjective dryness, any objective sign of WA, pH > 5, and body mass index of >= 18.5 to <= 36 kg/m(2). Subjects were randomized to 1 g of PCV gel twice a week for 30 days or 3 g of HA vaginal gel every 3 days for 30 days. Results: 53 subjects (mean age 49.45 +/- 2.96 years) were analyzed. Vaginal health index showed an improvement (p < 0.001) in both groups (from 12.54 +/- 1.37 to 16.36 +/- 2.66 for PCV, from 12.00 +/- 1.91 to 16.60 +/- 2.50 for HA), but the difference between final means (95%CI: -1.66 to 1.18) evidenced that PCV is non-inferior to HA treatment. Similarly, an improvement was evidenced in vaginal maturation index (p = 0.005 for PCV, ns. for HA), female sexual function index (p < 0.001 for PCV, p < 0.001 for HA), and SF-12 (p < 0.001 for PCV, p < 0.001 for HA), with no difference between groups. Safety was optimal and no adverse events were reported. Conclusions: The use of HA gel does not give additional benefits to those that are already provided by the moisturizing PCV. (C) 2022 The Author(s). Published by Elsevier B.V.