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

Angelo Cagnacci,Dionisio Franco Barattini,Elena Casolati,Alberto Pecoroni,Mario Mangrella,Liviu Cristian Patrascu

doi:10.1016/j.ejogrb.2022.01.021

Abstract

ObjectivesDuring menopausal transition, women are frequently affected by vulvovaginal atrophy (VVA), 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 methodsThis 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 VVA, pH > 5, and body mass index of ≥18.5 to ≤36 kg/m2. 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. Results53 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. ConclusionsThe use of HA gel does not give additional benefits to those that are already provided by the moisturizing PCV.

Highlights

The menopausal transition (MT) can be divided in an early and late phase [1]; the first characterized by skipped cycles, and the second by periods of amenorrhea up to 11 months
According to Instruction for Use (IFU) approved by Competent Authorities for the two medical devices, as requested by the ISO 14,155 and MEDDEV 2.12/1 for PMVF studies, dosage of polycarbophilic vaginal (PCV) could be increased to 1 g of gel every day from day 8 to day 30, if symptoms persisted at the 7-day phone call
One patient in the Hyaluronic acid (HA) group did not receive the investigational products (IP) for personal reasons (Fig. 1). 53 participants who received the IP for the whole period without major protocol deviations were analyzed for efficacy (PCV n = 28 and HA n = 25)

Summary

Introduction

The menopausal transition (MT) can be divided in an early and late phase [1]; the first characterized by skipped cycles, and the second by periods of amenorrhea up to 11 months. In this period symptoms of vulvovaginal atrophy (VVA), vaginal dryness, affects almost 1/3 of the population [2,3]. Non-hormonal vaginal lubricants and moistures represent first-line treatment for VVA symptoms, ospemifene or local hormones being considered second line remedies [9,10]. PCV is a safe treatment that moisturizes the vagina and increases epithelial fluid content without affecting vaginal pH [13].

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Conclusion