A Study of Oral VT-1161 for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
Status:
Completed
Trial end date:
2021-08-06
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 that it might be a safer and more effective treatment for RVVC than other
oral anti-fungal medicines.
This study will evaluate the effectiveness and safety of VT-1161 for the treatment of 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 with 3 150mg doses of fluconazole. The 2nd part consists of
12 weeks, when the patient will take either VT-1161 150 mg or a placebo (according to a
random assignment), and then a 36-week follow-up period.
In addition, at participating sites, an amendment to the study allows US patients who
complete the initial 48 weeks without experiencing a confirmed RVVC episode to continue in a
48-week observational extension period designed to evaluate the continued effectiveness of
VT-1161.
This study is identical to VMT-VT-1161-CL-012.