A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
- Registration Number
- NCT02267382
- Lead Sponsor
- Viamet
- Brief Summary
VT-1161 is a novel, oral inhibitor of fungal lanosterol demethylase (CYP51). In vitro and in vivo pharmacology studies have demonstrated that VT-1161 is highly active against Candida albicans and also non-albicans Candida species that cause vulvovaginal candidiasis. VT-1161 is highly selective for fungal CYP51, and data suggests that it may avoid the side-effect profile that limits the use of commonly prescribed antifungal agents for the treatment of recurrent yeast infections.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 254
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo Placebo 2 placebo tablets once daily for 7 days, then once weekly for 23 weeks VT-1161 Low-dose 3-month VT-1161 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 VT-1161 Low-dose 6-month VT-1161 1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks VT-1161 High-dose 3-month VT-1161 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 VT-1161 High-dose 24-week VT-1161 2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks
- Primary Outcome Measures
Name Time Method The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population. 48 Weeks A culture-verified acute VVC episode was defined as a positive fungal culture for Candida species associated with a clinical signs and symptoms score of ≥3. To calculate the 'signs and symptoms' score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with higher scores indicating a worse outcome.
0 = none (complete absence of any sign or symptom)
1. = mild (slight)
2. = moderate (definitely present)
3. = severe (marked, intense)
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (29)
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Precision Trials
🇺🇸Phoenix, Arizona, United States
NEA Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
Axis Clinical Trials
🇺🇸Los Angeles, California, United States
Genesis Center for Clinical Research
🇺🇸San Diego, California, United States
Altus Research
🇺🇸Lake Worth, Florida, United States
Healthcare Clinical Data
🇺🇸Miami, Florida, United States
Community Medical Research
🇺🇸North Miami, Florida, United States
Vision Clinical Research
🇺🇸Palm Beach, Florida, United States
Physician Care Clinical Research LLC
🇺🇸Sarasota, Florida, United States
Scroll for more (19 remaining)University of Alabama Birmingham🇺🇸Birmingham, Alabama, United States