Hydration and Acceptability of the Genital and Skin Mucosa of a Vaginal Moisturizer in Menopausal Women

Sponsor
Biolab Sanus Farmaceutica
Study ID
NCT06564883
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 0.20% sodium hyaluronate gel — DEVICE
    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.

Study Details

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

Key Dates

Start date
Mar 1, 2025
Status verified
Aug 2024
Primary completion
Sep 30, 2025
Completion
Oct 30, 2025

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm
    Hyaluronic Acid will applied under recommended conditions during the period of T22 ±2 days.

Primary Outcome Measure

Verify the hydration of the cutaneous and genital mucosa after using hyaluronic acid-based vaginal gel [ Time Frame: 22 days ]

Central Contacts

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