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

Launched by BIOLAB SANUS FARMACEUTICA · Aug 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a vaginal moisturizer that contains Hyaluronic Acid, which is designed to help relieve symptoms like vaginal dryness, itching, and irritation in menopausal women. The moisturizer aims to provide long-lasting hydration, potentially for up to 72 hours, making it easier for women experiencing conditions like vaginismus or vaginal atrophy to have a more comfortable sexual experience.

To participate in this trial, women must be menopausal, have mild to moderate vaginal dryness, and should not have used any hormonal treatments in the last six months. They should also be generally healthy and have an active sexual life. Participants will need to attend study visits and follow certain guidelines, like not using other vaginal products or having sexual intercourse shortly before the initial visit. This trial is not yet recruiting participants but aims to improve the quality of life for women facing these common challenges.

Gender

FEMALE

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.