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 @ 12:35 PM
Ignite Modification Date:
2025-12-24 @ 12:35 PM
NCT ID:
NCT03782961
Eligibility Criteria:
Inclusion Criteria:
* Menopausal participants for at least 6 months;
* Participants with complaints of vaginal dryness;
* Skin integrity in the region of product analysis;
* Agreement to comply the procedures of the trial and attend the clinic on the days and times determined for applications and / or evaluations;
* Understanding, agreement and signing of the Informed Consent Term.
Exclusion Criteria:
* Use of anti-inflammatory / immunosuppressive / antihistamine drugs up to 3 weeks prior to selection;
* Pathologies and / or active skin lesions (local and / or disseminated) in the evaluation area;
* Immunosuppression by drugs or active diseases;
* Decompensated endocrinopathies;
* Relevant clinical history or current evidence of alcohol or other drug abuse;
* known history or suspected intolerance to products of the same category;
* Intense sun exposure up to 15 days before evaluation;
* Gynecological treatment up to 4 weeks before evaluation;
* Other conditions considered by the researcher to be reasonable for disqualification of study participation.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
70 Years
Study:
NCT03782961
Study Brief:
Protocol Section:
NCT03782961