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

NCT ID: NCT06564883

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-10-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Arm

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

Group Type: EXPERIMENTAL

0.20% sodium hyaluronate gel

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Hyaluronic Acid

Eligibility Criteria

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Biolab Sanus Farmaceutica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Samuel Guerra Filho, MD

Role: CONTACT

negocios@grupoinvestiga.com

+55 19 37898610

Other Identifiers

BS-GIMM24

Identifier Type: -

Identifier Source: org_study_id