Real-World Effectiveness, Tolerability, and Patient Satisfaction With a Hyaluronic Acid-Based Vaginal Moisturizer in...

The objective of the study is to evaluate symptom improvement, safety, tolerability, and patient satisfaction associated with a hyaluronic acid-based internal vaginal moisturizer in women with symptomatic vaginal dryness under real-world conditions.

This prospective, multicenter, single-arm, open-label post-market clinical investigation was conducted in outpatient gynecology clinics in Spain between June and September 2022. Fifty-one women aged ≥18 years with symptomatic vaginal dryness were enrolled; 48 comprised the intention-to-treat population. Participants self-administered a CE-marked hyaluronic acid-based vaginal moisturizer three times weekly for six weeks. The primary endpoint was the change from baseline to week 6 in vaginal dryness severity measured using a non-validated 10-point visual analogue scale (VAS). Secondary endpoints included changes in irritation, itching, dyspareunia, vaginal hydration, vaginal pH, safety, and patient satisfaction. Within-subject changes were analyzed using paired comparisons.

In participants with paired baseline and week 6 data (n = 47), mean vaginal dryness severity decreased from 7.34 ± 2.20 to 3.47 ± 2.00. The mean change was -3.87 points (95% confidence interval (CI) -4.62 to -3.12; t = -10.5; p < 0.001), corresponding to a large within-subject standardized effect size (Cohen's dz = 1.54). Significant reductions were also observed for irritation (-2.11; n = 47), itching (-2.16; n = 45), and dyspareunia (-2.88; n = 42) (all p < 0.001). Vaginal hydration increased (+2.69; p < 0.001), and vaginal pH decreased modestly (-0.44; p = 0.001). Eight of 48 participants (16.7%) reported device-related adverse events, all mild to moderate; no serious adverse events occurred. Three participants discontinued due to adverse events.

In this prospective, real-world, single-arm clinical investigation, use of a hyaluronic acid-based vaginal moisturizer was associated with significant short-term reductions in vaginal dryness and related symptoms, with an acceptable safety profile. Given the absence of a comparator group, results should be interpreted cautiously. Findings should be considered hypothesis-generating.