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

Mycovia Pharmaceuticals Inc.219 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

219

Conditions

Recurrent Vulvovaginal Candidiasis

Interventions

Eligibility

Sex: FEMALEMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (33)

Tucson, Arizona, United States

Encino, California, United States

Los Angeles, California, United States

Englewood, Colorado, United States

Boca Raton, Florida, United States

Gainesville, Florida, United States

Leesburg, Florida, United States

Loxahatchee Groves, Florida, United States

Miami, Florida, United States

Savannah, Georgia, United States

...and 23 more locations

Outcomes

Primary Outcomes

Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-treat (ITT) Population

The primary efficacy outcome measure was the percentage of subjects with 1 or more culture-verified acute VVC episodes during the maintenance phase (post-randomization through Week 48) in the intent-to-treat population, which includes subjects who failed to clear their initial acute VVC episode during the induction phase. An acute VVC episode during the maintenance phase (considered a recurrent episode) was defined as a positive fungal culture for Candida species and a clinical signs and symptoms score of ≥3. To calculate the signs and symptoms score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with a higher score indicating a worse outcome. 0 = none (complete absence of any sign or symptom), 1 = mild (slight), 2 = moderate (definitely present), 3 = severe (marked, intense)

Time frame: 48 Weeks