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

Mycovia Pharmaceuticals Inc.425 enrolled

Overview

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 oteseconazole (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 oteseconazole (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 oteseconazole (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 oteseconazole (VT-1161). This study is identical to VMT-VT-1161-CL-011.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

425

Conditions

Recurrent Vulvovaginal Candidiasis

Interventions

Eligibility

Sex: FEMALEMin age: 12 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * 3 or more episodes of acute VVC in the past 12 months * Positive KOH or Gram stain test * 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

Locations (14)

31215

Phoenix, Arizona, United States

31227

Little Rock, Arkansas, United States

31217

Los Angeles, California, United States

31240

Hartford, Connecticut, United States

31204

Homestead, Florida, United States

31233

North Bay Village, Florida, United States

31255

Wichita, Kansas, United States

31245

Hagerstown, Maryland, United States

31223

Winston-Salem, North Carolina, United States

31244

Columbus, Ohio, United States

...and 4 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. 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: Maintenance phase (Baseline through Week 48)