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

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.

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

Females previously enrolled in the primary study (NCT07299432) who had not been diagnosed with recurrence of vulvovaginal candidiasis and successfully completed the Day 28 visit in the primary study.