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

NCT06564883 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-08-21

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Biolab Sanus Farmaceutica

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2025-09-30
Completion
2025-10-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06564883 on ClinicalTrials.gov