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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT02733432
Eligibility Criteria:
Inclusion Criteria:
* moderate to severe acute vulvovaginal candidiasis (severity score \>7)
* positive potassium hydroxide wet preparation for pseudohyphae or budding yeast or positive Becton Dickinson Affirm test or positive vaginal culture for Candida species
* vaginal pH \<4.5 for subjects with positive potassium hydroxide wet preparation
* able to give written informed consent
Exclusion Criteria:
* receipt of intravaginal or systemic antifungal therapy within 7 days of randomization
* known or suspected infectious causes of vulvovaginitis other than candidiasis
* history of genital herpes
* planned treatment or surgery during the study period for cervical intraepithelial neoplasia or cervical carcinoma
* need for non-protocol systemic or vaginal antifungal therapy
* history of hypersensitivity or allergic reaction to echinocandins, azoles, or their excipients
* pregnant females
* females who are breast feeding
* women intending to become pregnant during the study period
* recent use of an investigational medicinal product within 28 days or presence of an investigational device at the time of screening
* subjects who use or anticipate use of intravaginal products
* have any condition that the Investigator believes would put the subject at risk for participation or would confound the results of the study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02733432
Study Brief:
Protocol Section:
NCT02733432