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:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT04735705
Eligibility Criteria:
Inclusion Criteria:
* Adult females, aged 18 years to 65 years;
* Subjects presenting two or more vaginal symptoms such as leucorrhoea, pruritus, burning sensation, erythema, pain, odour, dysuria, or dyspareunia;
* Subjects with a diagnosis of either non-infectious vaginitis, or endogenous, symptomatic infection;
* Negative for Gardnerella vaginalis, Candida albicans, Trichomonas vaginalis;
* Subjects willing to provide signed informed consent to clinical investigation participation.
Exclusion Criteria:
* Subjects in menstrual period or suffering from menorrhagia;
* Colpectomy;
* Subjects with undiagnosed abnormal genital bleeding;
* Subject with vulvar, vaginal or cervical cancer;
* Known, active sexually transmitted infection (STI) in partner, as per anamnesis;
* Subjects with HIV or other immunodeficiency;
* Subjects with any pathology of the female reproductive organs;
* Known allergy or hypersensitivity to the medical device ingredients;
* Use of spermicides;
* Use of diaphragm;
* Concomitant topical or systemic anti-infective treatment;
* Unable to comply with visit procedures;
* Subjects included in other clinical investigations;
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04735705
Study Brief:
Protocol Section:
NCT04735705