Overview

A Study of Oral VT-1161 for the Treatment of Acute Vaginal Candidiasis (Yeast Infection) in Patients With Recurrent Vaginal Candidiasis

Status:
Completed

Trial end date:
2020-12-02

Target enrollment:

Participant gender:

Summary

Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is defined as at least 3 episodes of acute VVC in the past 12 months. Several properties of 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 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 period for the treatment of the patient's current VVC episode when the patient will take either fluconazole or VT-1161 (according to a random assignment). The second part consists of 11 weeks, when the patient will take either 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.

Phase:

Phase 3

Details

Lead Sponsor:

Mycovia Pharmaceuticals Inc.

Treatments:

Fluconazole