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: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mycovia Pharmaceuticals Inc.
• Treatments: Fluconazole

Criteria

Inclusion Criteria:

• 3 or more episodes of acute VVC in the past 12 months

• Positive KOH

• Total vulvovaginal signs and symptoms score of ≥3 at screening visit

• Total vulvovaginal signs and symptoms score of <3 at Day 14

• Must be able to swallow pills

Exclusion Criteria:

• Presence or a history of another vaginal or vulvar condition(s)

• Evidence of major organ system disease

• History of cervical cancer

• Poorly controlled diabetes mellitus

• Pregnant

• Recent use of topical or systemic antifungal or antibacterial drugs

• Recent use of immunosuppressive or systemic corticosteroid therapies