Open, Randomized, Parallel Group Study Assessing Efficacy, Safety, and Tolerability of 8 weeks of Vaginal Hyaluronic (V-HYAL) Gel in Peri- and Post-Menopausal Female

IntroductionVulvovaginal atrophy (VVA) affects nearly 50% of peri- and postmenopausal women, causing dryness, irritation, and discomfort due to lower estrogen levels. It can also lead to sexual dysfunction and significantly reduce quality of life, akin to serious conditions like arthritis and COPD. Treatments like low-dose local estrogen therapies are effective and safe, while hyaluronic acid offers a non-hormonal alternative with similar results. This study evaluates the efficacy, safety, and tolerability of vaginal Hyal (V-HYAL) gel for treating VVA symptoms in these women.MethodThe study is an open, randomized, parallel-group design involving 70 peri- and post-menopausal women, evenly divided into two groups: one receiving V-HYAL Gel and the other serving as the control. Participants were randomized in a 1:1 ratio, beginning with a screening visit, followed by assessments at Baseline (Day 0), Week 4 (via phone contact), and Week 8 (concluding the study). Efficacy was evaluated using various measures, including the Visual Analog Scale (VAS), High Vaginal Swab (HVS) based on Nugent score, vaginal pH, Vaginal Health Index (VHI), Female Sexual Functioning Index (FSFI), DIVA questionnaire, and monitoring for adverse events. Clinical Trial ID NCT06964646 (Registered 5/6/2025)ResultsBy week 8, the intervention group showed a significant reduction in vaginal dryness scores (p = 0.042) compared to the control, though there were no significant differences in VAS scores for itching, irritation, or urination issues. Vaginal Health Index (VHI) scores improved significantly in the intervention group, suggesting better outcomes in alleviating vaginal atrophy. While there was no significant difference in Nugent scores or vaginal pH between groups, the intervention group showed higher pH levels. FSFI results indicated notable improvements by day 56 in satisfaction with arousal (p = 0.017), orgasm (p = 0.033), emotional closeness (p = 0.042), sexual relationship satisfaction (p = 0.015), and overall sexual life (p = 0.008). The DIVA questionnaire reported increased spontaneity in sexual activity (p = 0.038) and interest in sexual relationships (p = 0.023). Three mild adverse events occurred, with only one possibly related to the product (vaginal itchiness).ConclusionThis study provides evidence of HA as a viable non-hormonal alternative to estrogen-based treatments, highlighting its comparable efficacy, safety, and tolerability. Minimal adverse effects were reported, with only one subject experiencing mild vaginal itching likely related to the investigational product.Registry: ClinicalTrials.gov, TRN: NCT06964646, Registration date: 05 June 2025.