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 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT05649735
Eligibility Criteria:
Inclusion criteria:
* Signed written informed consent
* Subjects diagnosed with vulvovaginitis
* Presence of at least two subjective symptoms and two objective signs (at least moderate) of vaginal inflammation. Vaginal inflammation will be assessed on six subjective symptoms (burning, pain, itching, vaginal dryness, dyspareunia and dysuria and four objective signs (leucorrhoea, vulvar erythema, vulvar oedema and presence of abrasion/erosion)
* The patient is able to read and understand the language and content of the study material, understand the requirements for follow-up visits, willing and able to provide information at scheduled assessments and willing and able to fulfil the requirements of the study
* PAP positive patients were allocated to group D
Exclusion Criteria:
* Persons who do not meet the inclusion criteria
* Patients who do not sign the informed consent form
* Other gynaecological diseases (in addition to cervicovaginitis), immunosuppressive diseases (i.e. HIV infection) or who are immunocompromised for reasons such as corticosteroid therapy, chemotherapy, anti-angiogenic agents or immunosuppressants
* Patients being treated with antibiotics, anti-inflammatory agents, analgesics, antineoplastic or immunosuppressive drugs within 10 days prior to inclusion in the study
* History of connective tissue disease, e.g. systemic lupus erythematosus, systemic sclerosis, Sjogren's syndrome or mixed connective tissue disease
* Known allergy to any component of the device
* Subjects who are unable to understand informed consent or who have a high probability of noncompliance with study procedures and/or noncompletion of the study in the judgment of the investigator
* Time between last day of last menstruation and baseline visit\> 16 days or ≤5 days
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05649735
Study Brief:
Protocol Section:
NCT05649735