A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
Recurrent Vulvovaginal Candidiasis
About this trial
This is an interventional treatment trial for Recurrent Vulvovaginal Candidiasis
Eligibility Criteria
Key Inclusion Criteria:
Clinical diagnosis of symptomatic acute VVC
3 or more episodes of acute VVC in the past 12 months
Positive KOH
Minimum composite vulvovaginal signs and symptoms score of ≥3 at Screening
Composite vulvovaginal signs and symptoms score of <3 at Baseline
Must be able to swallow tablets
Key Exclusion Criteria:
Evidence of major organ system disease
Presence or a history of another vaginal or vulvar condition(s)
History of cervical cancer
Poorly controlled diabetes mellitus
Pregnant
Recent use of topical or systemic antifungal drugs
Recent use of immunosuppressive or system corticosteroid therapies
Sites / Locations
- University of Alabama Birmingham
- Precision Trials
- NEA Baptist Clinic
- Axis Clinical Trials
- Axis Clinical Trials
- Genesis Center for Clinical Research
- Altus Research
- Healthcare Clinical Data
- Community Medical Research
- Vision Clinical Research
- Physician Care Clinical Research LLC
- Clinical Research of West Florida
- Cypress Medical Research Center
- Clinical Trials Management LLC
- Clinical Trials Management LLC
- New England Center for Clinical Research
- Clinical Research of Nevada
- R. Garn Mabey, Jr. M.D. Chartered
- OB/GYN Clinical Research
- Women's Health Research Center
- Suffolk OB-GYN
- United Women's Clinical Research-Raleigh
- Lyndhurst Clinical Research
- Radiant Research
- Drexel University College of Medicine
- Magee Women's Hospital
- Brownstone Clinical Trials
- TMC Life Research
- Brownstone Clinical Trials
- Clinical Trials of Texas
- Physician's Research Options LLC
- Seattle Women's Health Research Gynecology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
VT-1161 Low-dose 3-month
VT-1161 Low-dose 6-month
VT-1161 High-dose 3-month
VT-1161 High-dose 24-week
Placebo
1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks
2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks
2 placebo tablets once daily for 7 days, then once weekly for 23 weeks