Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT04342559
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
True
Sex:
FEMALE
Study:
NCT04342559
Study Brief:
Protocol Section:
NCT04342559