Hydration and Acceptability of the Genital and Skin Mucosa of a Vaginal Moisturizer in Menopausal… (NCT06564883) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Hydration and Acceptability of the Genital and Skin Mucosa of a Vaginal Moisturizer in Menopausal Women
45 participantsStarted 2025-03-01
Plain-language summary
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
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 day…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Verify the hydration of the cutaneous and genital mucosa after using hyaluronic acid-based vaginal gel
Timeframe: 22 days
2
Verify the acceptability of the cutaneous and genital mucosa after using hyaluronic acid-based vaginal gel