Hydration and Acceptability of the Genital and Skin Mucosa of a Vaginal Moisturizer in Menopausal Women
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorBiolab Sanus Farmaceutica
About this trial
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
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- 0.20% sodium hyaluronate gel
Treatment groups
45 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov