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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

NCT06564883•Biolab Sanus Farmaceutica

View on ClinicalTrials.gov

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

Eligibility

Age

All ages

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Healthy research participants, with an active sexual life;
•Intact skin and mucosa in the test region;
•Participants vaccinated for COVID-19 (Corona virus Disease).
•Agreement to adhere to the study procedures and requirements and attend the institute on the day(s) and time(s) determined for the assessments;
•Ability to consent to participate in the study;
•Menopausal participants of any age, without systemic or topical hormone replacement therapy in the last 6 months
•Presenting mild to moderate vaginal dryness (≥0.5 and \<7.5) - according to the Visual Analogic Scale
•Healthy research participants, with an active sex life (at least once a week)

Exclusion Criteria

•Skin pathology in the area of product application;
•Decompensated Diabetes Mellitus (TBD by the institute together with the sponsor);
•Immune insufficiency;
•Current use of the following topical or systemic medications: corticosteroids, immunosuppressants and antihistamines;
•Skin diseases: vitiligo, psoriasis, atopic dermatitis;
•Previous reaction to the category of the product tested;
•Other illnesses or medications that may directly interfere with the study or put the health of the research participant at risk.
•Have used vaginal moisturizing creams and/or intimate lubricants 5 days before the initial study visit;
•Have had sexual intercourse at least 48 hours before the initial study visit;
•Have been diagnosed with a urogenital or vaginal infection in the last 30 days;
+1 more criteria

Key Dates

Start Date

March 1, 2025

Primary Completion Date

September 30, 2025

Completion Date

October 30, 2025

Last Updated

August 21, 2024

Enrollment

ESTIMATED participants

Conditions

VaginismusVaginal AtrophyMenopause

Interventions

0.20% sodium hyaluronate gel

DEVICE

Contacts

Samuel Guerra Filho, MD

CONTACT

+55 19 37898610 negocios@grupoinvestiga.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 21, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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