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

• Status: Completed
• Trial end date: 2021-08-03
• 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 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 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-011.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mycovia Pharmaceuticals Inc.

Criteria

Key Inclusion Criteria:

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

• Positive KOH or Gram stain

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

• Total vulvovaginal signs and symptoms score of <3 at baseline visit

• Must be able to swallow pills

Key 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