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

NCT06564883 | Not Yet Recruiting Phase 3

• 1 other identifier: BS-GIMM24
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Relief of pruritus after using hyaluronic acid-based vaginal gel

  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.

  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.

  22 days

Study Arms (1)

Experimental Arm

EXPERIMENTAL

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

Device: 0.20% sodium hyaluronate gel

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.

Also known as: Hyaluronic Acid

Experimental Arm

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biolab Sanus Farmaceutica: lead

MeSH Terms

Conditions

Vaginismus

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

Samuel Guerra Filho, MD

CONTACT

+55 19 37898610; negocios@grupoinvestiga.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 21, 2024
• Study Start: March 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 30, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08