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:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT05507333
Eligibility Criteria:
Inclusion Criteria:
1. Having decisional capacity and providing written informed consent.
2. Adult, post-menarchal, pre-menopausal women, aged 18 years or older
3. Diagnosis of VVC, defined as:
* Having a white or creamy vaginal discharge
* At least 2 of the following signs and symptoms of VVC that are characterised as at least moderate: itching, burning, irritation, oedema, erythema, or excoriation.
* KOH or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts.
4. Negative urine pregnancy test at Screening.
5. Refrain from using any intravaginal products (i.e. contraceptive creams, gels, foams, sponges, lubricants, or tampons, etc.) until Day 14.
6. Refrain from sexual intercourse or use a condom until Day 7.
7. Signed informed consent and willing and able to comply with all study requirements.
Exclusion Criteria:
1. Patients with known or apparent signs of other infectious causes of vaginal infection (BV, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Herpes simplex, or human papillomavirus) at Screening.
2. Patients who are pregnant or breastfeeding.
3. Patients who were treated for VVC within 14 days prior to Screening.
4. Patients who are currently receiving anti-fungal therapy unrelated to VVC or has taken anti-fungal therapy within 14 days prior to Screening.
5. Patients who have received an investigational drug in a clinical investigation within 30 days prior to Screening.
6. Known/previous allergy or hypersensitivity to any product constituent or fluconazole.
7. Any medical condition that in the Investigator's judgements would make the patient unsuitable for inclusion.
8. More than 3 previous VVC infections during the last 12 months.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05507333
Study Brief:
Protocol Section:
NCT05507333