Status:
COMPLETED
Acceptability, Under Use in Real Conditions Of Two Vaginal Moistures Indicated for Women With Vaginal Drying
Lead Sponsor:
Libbs Farmacêutica LTDA
Conditions:
Vaginal Dryness
Eligibility:
FEMALE
Phase:
NA
Brief Summary
The studies carried out to evaluate the safety and efficacy of products aimed at the intimate area of women aim to confirm the absence of risk associated with its use, identify possible feelings of di...
Detailed Description
Moisturizers are used in chronic maintenance, replacing normal vaginal sections. Vaginal moisturizers rehydrate the mucosal tissue and are absorbed by the skin, adhering to the vaginal lining, thus m...
Eligibility Criteria
Inclusion
- Healthy research participants with an active sex life;
- Skin and intact mucosa in the test region;
- Agreement to adhere to the study's procedures and requirements and to attend the institute on the day (s) and time (s) determined for the assessments;
- Ability to consent to their participation in the study;
- Female research participants;
- Menopausal participants of any age;
- Participants who complain of vaginal dryness, classified at least as mild, and who present at least one of the following symptoms, in addition to vaginal dryness, also classified at least as mild (pain during or shortly after intercourse or discomfort during or soon after sexual intercourse).
Exclusion
- Have used moisturizing creams and / or vaginal lubricants 05 days before the initial study visit;
- Vaginal pathology in the product application area;
- Have had sex less than 48 hours before the visit;
- Have been diagnosed with 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 six weeks;
- Immune failure;
- Current use of the following medications for topical or systemic use: corticosteroids, immunosuppressants and antihistamines and in the last 7 days;
- History of reaction to the category of the product tested;
- Present vaginal bleeding on the day of visits;
- Other diseases or medications that may directly interfere with the study result or endanger the health of the research participant, at the discretion of the investigator.
Key Trial Info
Start Date :
April 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2020
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT04342559
Start Date
April 6 2020
End Date
April 6 2020
Last Update
April 13 2020
Active Locations (1)
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1
Augusto Theodoro de Figueiredo
São Paulo, Brazil, 01140050