Phase
Condition
Menopause
Vaginal Atrophy
Vaginitis
Treatment
0.20% sodium hyaluronate gel
Clinical Study ID
Female
Study Summary
Eligibility Criteria
Inclusion
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 theinstitute 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 replacementtherapy in the last 6 months
Presenting mild to moderate vaginal dryness (≥0.5 and <7.5) - according to theVisual Analogic Scale
Healthy research participants, with an active sex life (at least once a week)
Exclusion
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 thehealth of the research participant at risk.
Have used vaginal moisturizing creams and/or intimate lubricants 5 days before theinitial 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 ortreatment for vaginal atrophy in the last 30 days.