Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology · 2026
Performance and safety of a moisturising hyaluronic acid-based ovule in alleviating vaginal dryness and dyspareunia: a prospective multicentre study.
Clinical StudyСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Ghadri Ramez, Aperano-Mas Raïssa, Jean Christian, Keller Thierry, Noel Roxane, Houamel Dounia
Аннотация
BACKGROUND: Vulvovaginal dryness affects women of all ages and is particularly prevalent after menopause. Hyaluronic Acid (HA)-containing products may improve hydration and lubrication of the vulvovaginal mucosa.
OBJECTIVES: To assess the performance and safety of HA-based vaginal ovule (MucoGYNE), in relieving symptoms of vaginal dryness and dyspareunia.
METHODS: This prospective, multicentre, open-label, single-arm post-market clinical follow-up study enrolled women aged ≥18 years with vaginal dryness and a Vaginal Health Index (VHI) score <15. Participants inserted one ovule intravaginally twice weekly for 5 weeks. The primary outcome was change in VHI score from baseline (Day 0) to Day 35. Secondary outcomes included vulvovaginal symptoms, Female Sexual Function Index (FSFI), global impression of change, satisfaction, and safety.
RESULTS: Twenty-nine women were included in the analysis, with high treatment adherence (96.8%). VHI scores increased significantly (mean change +6.1 ± 3.1; p < 0.0001). Vulvovaginal symptoms improved significantly. FSFI scores improved. Investigators reported clinical improvement in 89.7% of participants, and 79.3% perceived improvement. Most women (86.2%) were satisfied with treatment. Three non-serious adverse events were reported.
CONCLUSIONS: Use of MucoGYNE Ovules was associated with improvements in vaginal dryness and related symptoms and a favourable safety profile, suggesting that it may represent a promising and well-tolerated non-hormonal option for women experiencing vaginal dryness. Clinical Trial: ClinicalTrials.gov (NCT06282614).
OBJECTIVES: To assess the performance and safety of HA-based vaginal ovule (MucoGYNE), in relieving symptoms of vaginal dryness and dyspareunia.
METHODS: This prospective, multicentre, open-label, single-arm post-market clinical follow-up study enrolled women aged ≥18 years with vaginal dryness and a Vaginal Health Index (VHI) score <15. Participants inserted one ovule intravaginally twice weekly for 5 weeks. The primary outcome was change in VHI score from baseline (Day 0) to Day 35. Secondary outcomes included vulvovaginal symptoms, Female Sexual Function Index (FSFI), global impression of change, satisfaction, and safety.
RESULTS: Twenty-nine women were included in the analysis, with high treatment adherence (96.8%). VHI scores increased significantly (mean change +6.1 ± 3.1; p < 0.0001). Vulvovaginal symptoms improved significantly. FSFI scores improved. Investigators reported clinical improvement in 89.7% of participants, and 79.3% perceived improvement. Most women (86.2%) were satisfied with treatment. Three non-serious adverse events were reported.
CONCLUSIONS: Use of MucoGYNE Ovules was associated with improvements in vaginal dryness and related symptoms and a favourable safety profile, suggesting that it may represent a promising and well-tolerated non-hormonal option for women experiencing vaginal dryness. Clinical Trial: ClinicalTrials.gov (NCT06282614).