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

Completed · Phase 3 · Has a placebo group

Conditions studied: Recurrent Vulvovaginal Candidiasis

In brief

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 oteseconazole (VT-1161) suggest that it might be a safer and more effective treatment for RVVC than other oral antifungal medicines. This study will evaluate the effectiveness and safety of oteseconazole (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 oteseconazole (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 oteseconazole (VT-1161). This study is identical to VMT-VT-1161-CL-011.

Key facts

Study ID
NCT03561701
Run by
Mycovia Pharmaceuticals Inc.
People needed
425
Starts
2018-08-23
Expected to finish
2021-08-03
Last updated by the study team
2026-02-17

Who can join

Age: 12 and older. Sex: female. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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