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 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT03656666
Eligibility Criteria:
Inclusion Criteria:
* Moderate to severe GELP at inclusion with the diagnosis based on characteristic clinical and/or histological features. Minimum GELP score 5/30 in vagina and/or vulva (scored separately), of which erythema and pain ≥1 are mandatory
* Informed consent from the patient to the protocol and clinical procedures.
Exclusion Criteria:
* Patients receiving other systemic immune modulating therapy
* Concomitant use of strong CYP3A4 enzyme inducers
* Inadequate birth control, pregnancy and/or breast-feeding
* Depression and suicidal ideation
* Patients with severe renal impairment
* Patients with active tuberculosis, serious infections or cancer
* Unexplained and clinically significant weight loss in underweight patients
* Hypersensitivity to the active substance(s) or to any of the excipients
* Hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption
* Participating in another trial that might affect the current study or there should be minimum 90 days between participation in another intervention trial
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03656666
Study Brief:
Protocol Section:
NCT03656666