Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections

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 vulvovaginal candidiasis (VVC) in the past 12 months. Several properties of oteseconazole (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 oteseconazole (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 induction phase for the treatment of the patient's current VVC episode when the patient will take either fluconazole or oteseconazole (VT-1161) according to a random assignment. The second part consists of an 11-week maintenance phase, when the patient will take either oteseconazole (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.

Key facts

Study ID

NCT03840616

Run by

Mycovia Pharmaceuticals Inc.

People needed

219

Starts

2019-03-13

Expected to finish

2020-12-02

Last updated by the study team

2022-02-04

Who can join

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

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• 34 — Tucson, Arizona, United States
• 39 — Encino, California, United States
• 25 — Los Angeles, California, United States
• 22 — Englewood, Colorado, United States
• 49 — Boca Raton, Florida, United States
• 14 — Gainesville, Florida, United States
• 13 — Leesburg, Florida, United States
• 33 — Loxahatchee Groves, Florida, United States
• 36 — Miami, Florida, United States
• 17 — Savannah, Georgia, United States
• 27 — Idaho Falls, Idaho, United States
• 10 — Nampa, Idaho, United States
• 62 — Chicago, Illinois, United States
• 41 — Fort Wayne, Indiana, United States
• 30 — Marrero, Louisiana, United States
• 50 — Dearborn Heights, Michigan, United States
• 29 — Saginaw, Michigan, United States
• 55 — Traverse City, Michigan, United States
• 32 — Troy, Michigan, United States
• 26 — Kansas City, Missouri, United States
• 42 — New Brunswick, New Jersey, United States
• 47 — Ocean City, New Jersey, United States
• 37 — Charlotte, North Carolina, United States
• 38 — Fayetteville, North Carolina, United States
• 15 — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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