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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Menopause; Vaginal Atrophy; Vaginismus
• Intervention / Treatment: Device: 0.20% sodium hyaluronate gel

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Samuel Guerra Filho, MD; Phone Number: +55 19 37898610; Email: negocios@grupoinvestiga.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;
• Have used topical or systemic antibiotics, antifungals, hormone-based creams or treatment for vaginal atrophy in the last 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm; Hyaluronic Acid will applied under recommended conditions during the period of T22 ±2 days.	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.; Other Names: Hyaluronic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Biolab Sanus Farmaceutica

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Vaginal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vaginismus; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: BS-GIMM24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No