Non-Interventional Extension to Investigate Recurrence of Vulvovaginal Candidiasis and Candida Colonization
- Conditions
- MycosesYeast InfectionCandidiasis, VulvovaginalMoniliasis, VulvovaginalVaginitis, Monilial
- Registration Number
- NCT02888197
- Lead Sponsor
- Cidara Therapeutics Inc.
- Brief Summary
Non-interventional extension study to investigate VVC recurrence and candida colonization following the P2 acute VVC study
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 32
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to recurrence of clinical signs/symptoms of VVC Up to Day 90 +/- 14 days Time to recurrence of clinical signs/symptoms of VVC
- Secondary Outcome Measures
Name Time Method Rate of candida colonization Up to Day 90 +/- 14 days Rate of candida colonization
Rates of recurrence of culture confirmed VVC Up to Day 90 +/- 14 days Rates of recurrence of culture confirmed VVC
Rate of recurrence of clinical signs/symptoms of VVC Up to Day 90 +/- 14 days Rate of recurrence of clinical signs/symptoms of VVC
Time to recurrence of culture confirmed VVC Up to Day 90 +/- 14 days Time to recurrence of culture confirmed VVC
Trial Locations
- Locations (23)
The Women's Clinical, P.A.
🇺🇸Little Rock, Arkansas, United States
Soffolk OB/GYN
🇺🇸Port Jefferson, New York, United States
Eastern Carolina Women's Center
🇺🇸New Bern, North Carolina, United States
Altus Research Inc
🇺🇸Lake Worth, Florida, United States
Clinical Trials Management LLC
🇺🇸Metairie, Louisiana, United States
Saginaw Valley Medical Research Group LLC
🇺🇸Saginaw, Michigan, United States
Hawthorne Medical Research Inc
🇺🇸Winston-Salem, North Carolina, United States
Lawrence OB GYN Clinical Research LLC
🇺🇸Lawrenceville, New Jersey, United States
Alliance Women's Research Group LLC
🇺🇸Delran, New Jersey, United States
Tidwewater Physicians for Women
🇺🇸Norfolk, Virginia, United States
Olympian Clinical Research
🇺🇸Clearwater, Florida, United States
Women's Medical Research
🇺🇸Clearwater, Florida, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Drexel University
🇺🇸Philadelphia, Pennsylvania, United States
Women's Health Research
🇺🇸Columbus, Ohio, United States
Precision Trials AZ
🇺🇸Phoenix, Arizona, United States
Women's Health Care Research Corp
🇺🇸San Diego, California, United States
New Age Medical Research Corporation
🇺🇸Miami, Florida, United States
Seattle Women's Health, Research, Gynecology
🇺🇸Seattle, Washington, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
TMC Life Research Inc.
🇺🇸Houston, Texas, United States
Clinical Trials of Texas Inc
🇺🇸San Antonio, Texas, United States
Unified Women's Clinical Research - Hickory
🇺🇸Winston-Salem, North Carolina, United States