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:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
NCT ID:
NCT03761628
Eligibility Criteria:
Inclusion Criteria:
* Adult, post-menarchal, pre-menopausal women aged 18 years or older
* Diagnosis of VVC, defined as having a white or creamy vaginal discharge plus the following findings:
1. At least 2 of the following signs and symptoms of VVC that are characterized as at least moderate: itching, burning, irritation, edema, redness, or excoriation.
2. Potassium hydroxide (KOH) or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts.
* Having decisional capacity and providing written informed consent
* Negative urine pregnancy test at screening
* Refrain from using any intravaginal products (i.e., contraceptive creams, gels, foams, sponges, lubricants, or tampons, etc.) during the study period
* Refrain from sexual intercourse or use a condom until Day 7
* Signed informed consent and willing and able to comply with all study requirements
Exclusion Criteria:
* Patients with known or apparent signs of other infectious causes of VVC (BV, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Herpes simplex, or human papillomavirus) at screening
* Patients who are pregnant or breastfeeding
* Patients who were treated for VVC within the past 14 days
* Patients who are currently receiving antifungal therapy unrelated to VVC or has taken antifungal therapy within the past 14 days
* Patients who have used pH-modifying vaginal products within the last 14 days
* Patients who have received an investigational drug in a clinical investigation within 30 days prior to screening
* Known/previous allergy or hypersensitivity to any product constituent or fluconazole
* Any medical condition that in the Investigator's judgments would make the patient unsuitable for inclusion
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03761628
Study Brief:
Protocol Section:
NCT03761628