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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
0.20% sodium hyaluronate gel
DeviceHyaluronic 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.
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: Experimental ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Verify the hydration of the cutaneous and genital mucosa after using hyaluronic acid-based vaginal gel
To evaluate the perceived hydration effectiveness, a visual analogue scale will be used, where the minimum value (zero) represents no dryness and the maximum value (ten) represents extremely dryness. Lower scores indicate improved vaginal hydration.
Time frame
22 days2
Verify the acceptability of the cutaneous and genital mucosa after using hyaluronic acid-based vaginal gel
To assess skin acceptability, an epithelial integrity questionnaire will be used, where a score, on a 5-point scale, will be assigned after evaluation by the gynecologist. The lowest score will be 1, representing "petechiae before contact" and the maximum score will be 5 with "thin, non-friable mucosa". The higher the score, the healthier and more intact the epithelium will be.
Time frame
22 daysSecondary outcomes
1
Relief of pruritus after using hyaluronic acid-based vaginal gel
The relief of pruritus assessment will be evaluates through an Visual Analogic Scale. Where the minimum value (zero) represents no pruritus and the maximum value (ten) represents extremely pruritus. Lower scores indicate improvement or absence of vaginal pruritus.
Time frame
22 days2
Verify the maintenance of pH after using Hyaluronic Acid when applied under recommended conditions of use through gynecologist follow-up during the use.
pH maintenance will be assessed using reagent strips.
Time frame
22 days3
Verify the maintenance of vaginal microbiota after using Hyaluronic Acid when applied under recommended conditions of use through gynecologist follow-up during the use.
Bacterioscopic collection of vaginal contents using a sterile swab. The swabs containing the samples will be placed in test tubes sent to the laboratory for microbiological analysis.
Time frame
22 daysLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: