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 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT02679456
Eligibility Criteria:
Inclusion Criteria:
Subjects must fulfill all of the following criteria to be eligible for study admission:
1. Female subjects from 18 to 65 years of age in good general health
2. Diagnosis of symptomatic moderate to severe vulvovaginal candidiasis
3. The ability to understand and sign a written informed consent form (ICF), which must be obtained prior to treatment and any study-related procedures.
4. The ability to understand and sign a consent or authorization form which shall permit the use, disclosure and transfer of the subject's personal health information (e.g., in the U.S. HIPAA Authorization form).
5. The ability to understand and follow all study-related procedures including study drug administration.
6. Females of childbearing potential must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
Exclusion Criteria:
A subject will be excluded from participation in the study if she meets any of the following exclusion criteria:
1. Any vaginal condition other than VVC that may interfere with the diagnosis or evaluation of response to therapy.
2. Prior use of any prohibited medication(s) or procedure(s) within the protocol specified timeframe including:
a. Systemic and/or topical (vaginal) antifungal treatment, prescription or over the counter, within 30 days of the baseline visit.
3. Subjects with history of renal impairment, hepatic impairment or cervical cancer.
4 Subjects with known hypersensitivity to enfumafungin derivatives, fluconazole or any of the components of the formulation.
5\. HIV infection, chemotherapy or illness serious enough to induce an immune deficiency.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02679456
Study Brief:
Protocol Section:
NCT02679456