Non-Interventional Extension to Investigate Recurrence of Vulvovaginal Candidiasis and Candida Colonization

Cidara Therapeutics

Status: Completed

Conditions: Yeast Infection; Vaginitis, Monilial; Mycoses; Moniliasis, Vulvovaginal; Candidiasis, Vulvovaginal

Study type: Observational

Funder types: Industry

Identifiers

NCT02888197

CD101.TP.2.02

Details and patient eligibility

About

Non-interventional extension study to investigate VVC recurrence and candida colonization following the P2 acute VVC study

Full description

Following completion of the Phase 2, multicenter, randomized, active-controlled study of the safety and tolerability of two formulations of CD101 compared to fluconazole for the treatment of moderate to severe episodes of acute vulvovaginal candidiasis (NCT07299432), subjects without a recurrence of VVC will be followed up to an additional 90 days +/- 14 days to assess candida colonization and recurrence of VVC.

Enrollment: 32 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Enrollment in and completed the primary study through the Day 28 visit.
• Received at least one dose of study drug in the primary study
• Able to give written informed consent prior to completion of the primary study

Exclusion criteria

• Received systemic or topical vaginal non-study antifungal therapy at any time during the primary study
• Diagnosed with bacterial vaginosis, trichomonas, gonorrhea, chlamydia, or active herpes at any point during the primary study
• The Principal Investigator considers that the subject should not participate in the study