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

Biolab Pharma

Status and phase

Not yet enrolling

Phase 3

Conditions

Menopause

Vaginal Atrophy

Vaginismus

Treatments

Device: 0.20% sodium hyaluronate gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT06564883

BS-GIMM24

Details and patient eligibility

About

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

Enrollment

45 estimated patients

Sex

Female

Volunteers

No 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;
Have used topical or systemic antibiotics, antifungals, hormone-based creams or treatment for vaginal atrophy in the last 30 days.