Clinical trial NCT06564883: Hydration and Acceptability of the Genital and Skin Mucosa of a Vaginal Moisturizer in Menopausal Women
Official title: Clinical Evaluation of Hydration and Acceptability of the Genital and Cutaneous Mucosa of a Vaginal Moisturizer in Vaginal Dryness in Menopausal Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Vaginismus
Vaginal Atrophy
Menopause
Lead sponsor: Biolab Sanus Farmaceutica
Sponsor class: INDUSTRY
First posted: 2024-08-21
Enrollment: 45
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Verify the hydration of the cutaneous and genital mucosa after using hyaluronic acid-based vaginal gel
timeFrame: 22 days
measure: Verify the acceptability of the cutaneous and genital mucosa after using hyaluronic acid-based vaginal gel
timeFrame: 22 days
Secondary outcomes:
measure: Relief of pruritus after using hyaluronic acid-based vaginal gel
timeFrame: 22 days
measure: Verify the maintenance of pH after using Hyaluronic Acid when applied under recommended conditions of use through gynecologist follow-up during the use.
timeFrame: 22 days
measure: Verify the maintenance of vaginal microbiota after using Hyaluronic Acid when applied under recommended conditions of use through gynecologist follow-up during the use.
timeFrame: 22 days
Other outcomes:
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