Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections

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.

Timeline

Start

2019-03-13

Primary completion

2020-12-02

Completion

2020-12-02

Publications

• Vanreppelen G, Nysten J, Baldewijns S, Sillen M, Donders G, Van Dijck P. Oteseconazole (VIVOJA) for prevention of recurrent vulvovaginal candidiasis. Trends Pharmacol Sci. 2023 Jan;44(1):64-65. doi: 10.1016/j.tips.2022.10.004. Epub 2022 Nov 14. No abstract available.

Drugs

Indications