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 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT03167957
Eligibility Criteria:
Inclusion Criteria:
* Female 18-65 years
* Informed Consent
* Clinical diagnosis of fluconazole-resistant VVC
* Negative pregnancy test
* Vaginal pH ≤ 4.5
Exclusion Criteria:
* Intolerance or hypersensitivity to any amphotericin B (AMB) product or to azole antifungal drugs
* Receiving antifungal therapy unrelated to VVC or has evidence of systemic fungal infections requiring antifungal therapy
* Received antifungal treatment for VVC within past 10 days except fluconazole, subjects must discontinue fluconazole after informed consent
* Has another cause or suspected cause of vulvovaginitis
* Has active HPV
* Has other urogenital infection
* Has other vaginal or vulvar condition that would confound interpretation of clinical response
* Has significant laboratory abnormality at screening
* Has Type I diabetes, use of insulin, HbA1c\>10
* Exposure to any investigational product within 30 days of screening
* Has other condition that would interfere with subject ability to provide informed consent or put subject at undue risk
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03167957
Study Brief:
Protocol Section:
NCT03167957