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

Phase 3

Not yet recruiting

• Conditions: Vaginismus; Vaginal Atrophy; Menopause

• Registration Number: NCT06564883
• Lead Sponsor: Biolab Sanus Farmaceutica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-15
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Healthy research participants, with an active sexual life;<br><br> - Intact skin and mucosa in the test region;<br><br> - Participants vaccinated for COVID-19 (Corona virus Disease).<br><br> - Agreement to adhere to the study procedures and requirements and attend the<br> institute on the day(s) and time(s) determined for the assessments;<br><br> - Ability to consent to participate in the study;<br><br> - Menopausal participants of any age, without systemic or topical hormone replacement<br> therapy in the last 6 months<br><br> - Presenting mild to moderate vaginal dryness (=0.5 and <7.5) - according to the<br> Visual Analogic Scale<br><br> - Healthy research participants, with an active sex life (at least once a week)<br><br>Exclusion Criteria:<br><br> - Skin pathology in the area of product application;<br><br> - Decompensated Diabetes Mellitus (TBD by the institute together with the sponsor);<br><br> - Immune insufficiency;<br><br> - Current use of the following topical or systemic medications: corticosteroids,<br> immunosuppressants and antihistamines;<br><br> - Skin diseases: vitiligo, psoriasis, atopic dermatitis;<br><br> - Previous reaction to the category of the product tested;<br><br> - Other illnesses or medications that may directly interfere with the study or put the<br> health of the research participant at risk.<br><br> - Have used vaginal moisturizing creams and/or intimate lubricants 5 days before the<br> initial study visit;<br><br> - Have had sexual intercourse at least 48 hours before the initial study visit;<br><br> - Have been diagnosed with a urogenital or vaginal infection in the last 30 days;<br><br> - Have used topical or systemic antibiotics, antifungals, hormone-based creams or<br> treatment for vaginal atrophy in the last 30 days.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Verify the hydration of the cutaneous and genital mucosa after using hyaluronic acid-based vaginal gel;Verify the acceptability of the cutaneous and genital mucosa after using hyaluronic acid-based vaginal gel

Secondary Outcome Measures

Name	Time	Method
Relief of pruritus after using hyaluronic acid-based vaginal gel;Verify the maintenance of pH after using Hyaluronic Acid when applied under recommended conditions of use through gynecologist follow-up during the use.;Verify the maintenance of vaginal microbiota after using Hyaluronic Acid when applied under recommended conditions of use through gynecologist follow-up during the use.