Vulvovaginal dryness is a common complaint affecting women across the lifespan and is particularly prevalent after menopause. Moisturising and lubricating strategies are often used to address mucosal hydration and symptomatic discomfort. Hyaluronic acid (HA) is a hydrophilic molecule used in topical gynecologic preparations intended to improve mucosal hydration and lubrication. The present study evaluated a marketed HA‑containing vaginal ovule (MucoGYNE) to assess its performance and safety for relief of vaginal dryness and associated dyspareunia.
This research was a prospective, multicentre, open‑label, single‑arm post‑market clinical follow‑up study. Women aged 18 years or older who had symptoms of vaginal dryness and a baseline Vaginal Health Index (VHI) score below 15 were eligible for inclusion. The study was conducted at multiple centres in France and is registered on ClinicalTrials.gov under identifier NCT06282614.
Participants were instructed to insert one MucoGYNE ovule intravaginally twice weekly for a total duration of five weeks. The treatment schedule and product were applied consistently across the enrolled cohort as described in the study protocol reported in the abstract.
The primary outcome measure was the change in Vaginal Health Index (VHI) score from baseline (Day 0) to the end of treatment (Day 35). Secondary outcomes included assessment of vulvovaginal symptoms, the Female Sexual Function Index (FSFI), investigator and patient global impressions of change, patient satisfaction with treatment, and safety monitoring for adverse events.
Twenty‑nine women were included in the analysis population. Treatment adherence was high, with a reported adherence rate of 96.8%. The primary endpoint demonstrated a statistically significant improvement in VHI: mean change from baseline to Day 35 was +6.1 ± 3.1 points (p < 0.0001). This finding indicates an objective improvement in assessed vaginal health over the five‑week treatment period with the HA‑based ovule.
The abstract reports significant improvement in vulvovaginal symptoms following treatment with the HA ovule. FSFI scores also improved during the study, although the abstract does not provide specific numeric values for FSFI change. Investigators judged that 89.7% of participants experienced clinical improvement. From the patient perspective, 79.3% perceived an improvement in their condition, and 86.2% of women expressed satisfaction with the treatment received.
Safety assessment in this prospective follow‑up identified three non‑serious adverse events. No serious adverse events were reported in the abstract. The authors describe the overall safety profile as favourable. The specific nature of the non‑serious events was not detailed in the abstract.
In this single‑arm, open‑label cohort, use of the MucoGYNE hyaluronic acid‑based ovule twice weekly for five weeks was associated with statistically significant improvement in the Vaginal Health Index, reductions in vulvovaginal symptoms, improvements in sexual function scores on the FSFI (reported as improved), and high rates of investigator‑assessed and patient‑reported improvement and satisfaction. The product demonstrated a favourable tolerability profile with only three non‑serious adverse events reported. The authors conclude that MucoGYNE may represent a promising non‑hormonal treatment option for women experiencing vaginal dryness and dyspareunia.
The abstract provides limited methodological and outcome detail. Specifics not reported in the abstract include demographic breakdowns (age distribution beyond eligibility), etiologies of vaginal dryness (for example, menopausal status), exact numeric changes in FSFI domains, the nature and timing of the three non‑serious adverse events, and any longer‑term follow‑up beyond Day 35. As a single‑arm, open‑label post‑market study, the trial lacks a randomized comparator group; the implications for comparative efficacy relative to other non‑hormonal or hormonal therapies are therefore not addressed in the available abstract. Readers seeking full methodological details and complete results should consult the full manuscript or the ClinicalTrials.gov entry NCT06282614 for supplemental information.