Status:
NOT_YET_RECRUITING
Hydration and Acceptability of the Genital and Skin Mucosa of a Vaginal Moisturizer in Menopausal Women
Lead Sponsor:
Biolab Sanus Farmaceutica
Conditions:
Vaginismus
Vaginal Atrophy
Eligibility:
FEMALE
Phase:
PHASE3
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 pr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06564883
Start Date
March 1 2025
End Date
October 30 2025
Last Update
August 21 2024
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