At a glance
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Phase 3, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oteseconazole (VT-1161) Oral Capsules vs Fluconazole and Placebo in Treatment of Acute Vulvovaginal Candidiasis in Subjects With Recurrent Vulvovaginal Candidiasis
In Brief
A Phase 3 clinical trial evaluating Oteseconazole (VT-1161) 150mg capsule, Fluconazole 150mg capsule, and 1 other intervention for Recurrent Vulvovaginal Candidiasis. Completed, enrolled 219 participants across 33 sites.
Detailed Summary
Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is defined as at least 3 episodes of acute vulvovaginal candidiasis (VVC) in the past 12 months. Several properties of oteseconazole (VT-1161) suggest it might be a safer and more effective treatment of RVVC than other oral antifungal medications. This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for the treatment of acute VVC episodes in patients with RVVC and consists of 2 parts. The first part of the study is a 2-week induction phase for the treatment of the patient's current VVC episode when the patient will take either fluconazole or oteseconazole (VT-1161) according to a random assignment. The second part consists of an 11-week maintenance phase, when the patient will take either oteseconazole (VT-1161) or a placebo according to the random assignment from the first part of the study, and then a 37-week follow-up period.
Study Details
Timeline
Interventions
600mg administered on Day 1 and 450mg administered on Day 2, followed by 150mg administered once weekly for 11 weeks staring on Day 14.
150mg administered every 72 hours in 3 sequential doses starting on Day 1.
Administered once weekly starting on Day 14.