An open, single center, clinical investigation to evaluate the efficacy and safety of a non-hormonal vaginal moisturizer for the symptomatic treatment of vulvovaginal atrophy in postmenopausal woman

Abstract

Objective: To evaluate the efficacy and safety of a non-hormonal vaginal moisturizer in alleviating the clinical symptoms of vulvovaginal atrophy (VVA). Methods: This was an observational, single center, open label study in which the investigational product was applied to postmenopausal women (n = 36) with VVA symptoms three times per week for a period of 12 weeks. Patient’s perception of vaginal discomfort, sexual function improvement assessed with the Female Sexual Function Index (FSFI), quality of life evaluated with the Cervantes-SF scale, and subject’s satisfaction with the treatment were evaluated after 4 and 12 weeks of product use. In addition, vaginal health was evaluated with the Vaginal Health Index (VHI) score and the vaginal pH. Results: A statistically significant decrease was observed in the severity of the most bothersome symptoms from moderate at baseline (mean 2.47 ± 0.55) to mild after 4 weeks (mean 1.33 ± 0.58) and 12 weeks (mean 1.32 ± 0.74, p < 0.0001). VHI scores significantly improved after 4 and 12 weeks compared to baseline (from 11.70 to 16.36 at 4 weeks and 17.34 at 12 weeks, both p < 0.0001). Vaginal pH decreased significantly from a mean pH of 6.27 ± 0.46 at baseline to 5.77 ± 0.59 at 4 weeks and 5.56 ± 0.60 at 12 weeks of treatment (p < 0.0001). Total FSFI scores significantly increased, indicating improvement of sexual function, after 4 and then after 12 weeks of product use (Baseline score 20.16 compared to 24.27 at 4 and 23.94 at 12 weeks, both p < 0.0001). Quality of life improved (decrease of total Cervantes-SF scores) after 12 weeks of product use as compared to baseline (Baseline 32.09 vs 26.45, p = 0.0004). At 12 weeks, a 97.5% reported overall satisfaction with the product and no adverse events related to the product were reported. Conclusion: Through limited size study, the proposed non-hormonal vaginal moisturizer demonstrated being effective and safe for the management of VVA symptoms in postmenopausal women, offering significant improvements in symptom severity, vaginal health, sexual function, and quality of life. There is a need for further research with a larger sample and comparison with other similar products.