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

Mycovia Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Recurrent Vulvovaginal Candidiasis

Treatments: Drug: Placebo; Drug: Oteseconazole (VT-1161) 150mg capsule; Drug: Fluconazole 150mg capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT03840616

VMT-VT-1161-CL-017

Details and patient eligibility

About

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.

Enrollment: 219 patients

Sex: Female

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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219 participants in 2 patient groups

Oteseconazole (VT-1161) 150mg capsule

Experimental group

Description:

600mg oteseconazole administered on Day 1 and 450mg administered on Day 2, followed by 150mg administered once weekly for 11 weeks staring on Day 14

Treatment:

Drug: Oteseconazole (VT-1161) 150mg capsule

Fluconazole 150mg capsule / Placebo

Active Comparator group

Description:

150mg fluconazole administered every 72 hours in 3 sequential doses starting on Day 1, followed by placebo administered once weekly starting on Day 14

Treatment:

Drug: Placebo

Drug: Fluconazole 150mg capsule