NCT06564883

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

Clinical Evaluation of Hydration and Acceptability of the Genital and Cutaneous Mucosa of a Vaginal Moisturizer in Vaginal Dryness in Menopausal Women

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Biolab Sanus Farmaceutica · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Vaginismus
• Vaginal Atrophy
• Menopause

Interventions

Type	Name	Description
DEVICE	0.20% sodium hyaluronate gel	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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-09-30
• Completion: 2025-10-30
• First posted: 2024-08-21
• Last updated: 2024-08-21