Conditions: Recurrent Vulvovaginal Candidiasis
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 254
Healthy volunteers: no

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:

Arms:
arm 1: 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 arm 2: 1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks arm 3: 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 arm 4: 2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks arm 5: 2 placebo tablets once daily for 7 days, then once weekly for 23 weeks

Interventions: intervention 1: VT-1161 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: