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 @ 12:17 PM
Ignite Modification Date:
2025-12-26 @ 12:17 PM
NCT ID:
NCT02180100
Eligibility Criteria:
Inclusion Criteria:
* Vulvovaginal candidiasis infection is diagnosed, the symptoms evaluated using a numerical rating system based on severity (absent=0; mild=1; moderate=2; severe=3) with a minimum VVC Composite Signs/Symptoms score of 7
* Subject completes the informed consent process
* Subject agrees to take study medication when scheduled
* Subject complies with all clinical trial instructions. Commits to all follow-up visits
* Subject agrees to abstain from sexual intercourse from the time of randomization through the first seven days immediately following treatment
Exclusion Criteria:
* had any other sexually transmitted disease or gynaecological abnormality requiring treatment
* had a disease known to predispose to candidiasis such as diabetes mellitus, or were receiving antibiotics or corticosteriods
* had used antifungal medication in the week before entry; or
* were expected to menstruate within seven days of the start of treatment
* infected more than one candida species
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
48 Years
Study:
NCT02180100
Study Brief:
Protocol Section:
NCT02180100