Hydration and Acceptability of the Genital and Skin Mucosa of a Vaginal Moisturizer in Menopausal Women
NCT Number: NCT06564883
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Vaginismus|Vaginal Atrophy|Menopause
Interventions: DEVICE: 0.20% sodium hyaluronate gel
Sponsor: Biolab Sanus Farmaceutica
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-03-01
Completion Date: 2025-10-30

Summary:
Hyaluronic Acid is indicated for the relief of vaginal dryness, itching, and irritation, or the reduction of vaginal lubrication with prolonged hydration effects for up to 72 hours. Hyaluronic Acid promotes vaginal moisture, providing symptom relief in various situations such as:

* Vaginismus and other sexual dysfunctions related to penetration
* Users of hormonal contraceptives with lubrication loss
* Postpartum and lactational period
* Post antibacterial or antifungal therapies
* During systemic oncological treatments (chemotherapy, radiotherapy, hormone therapy)
* Climacteric (urogenital atrophy)
* Post urogynecological surgeries (correction of urinary incontinence, genital dystopias, etc.)
* Post vulvovaginal abrasive, chemical, laser, or high-frequency therapies
* Post cosmetic and genital rejuvenation therapies

Primary Outcome Measures: Verify the hydration of the cutaneous and genital mucosa after using hyaluronic acid-based vaginal gel, To evaluate the perceived hydration effectiveness, a visual analogue scale will be used, where the minimum value (zero) represents no dryness and the maximum value (ten) represents extremely dryness. Lower scores indicate improved vaginal hydration., 22 days|Verify the acceptability of the cutaneous and genital mucosa after using hyaluronic acid-based vaginal gel, To assess skin acceptability, an epithelial integrity questionnaire will be used, where a score, on a 5-point scale, will be assigned after evaluation by the gynecologist. The lowest score will be 1, representing "petechiae before contact" and the maximum score will be 5 with "thin, non-friable mucosa". The higher the score, the healthier and more intact the epithelium will be., 22 days
Secondary Outcome Measures: Relief of pruritus after using hyaluronic acid-based vaginal gel, The relief of pruritus assessment will be evaluates through an Visual Analogic Scale. Where the minimum value (zero) represents no pruritus and the maximum value (ten) represents extremely pruritus. Lower scores indicate improvement or absence of vaginal pruritus., 22 days|Verify the maintenance of pH after using Hyaluronic Acid when applied under recommended conditions of use through gynecologist follow-up during the use., pH maintenance will be assessed using reagent strips., 22 days|Verify the maintenance of vaginal microbiota after using Hyaluronic Acid when applied under recommended conditions of use through gynecologist follow-up during the use., Bacterioscopic collection of vaginal contents using a sterile swab. The swabs containing the samples will be placed in test tubes sent to the laboratory for microbiological analysis., 22 days