A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
- Conditions
- Recurrent Vulvovaginal Candidiasis
- Interventions
- Drug: Placebo
- Registration Number
- NCT03562156
- Lead Sponsor
- Mycovia Pharmaceuticals Inc.
- Brief 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 oteseconazole (VT-1161) suggest that it might be a safer and more effective treatment for RVVC than other oral anti-fungal 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-012 (NCT03561701).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 438
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oteseconazole (VT-1161) 150mg capsule Oteseconazole (VT-1161) Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks Placebo capsule Placebo Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks
- Primary Outcome Measures
Name Time Method Percentage of Subjects With 1 or More Culture-Verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-Treat Population Maintenance phase (post-randomization through Week 48) 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
31143
🇺🇸Sarasota, Florida, United States
31132
🇺🇸Greensboro, North Carolina, United States
31134
🇺🇸Philadelphia, Pennsylvania, United States
31105
🇺🇸Metairie, Louisiana, United States
31102
🇺🇸Houston, Texas, United States
31118
🇺🇸Las Vegas, Nevada, United States
31108
🇺🇸San Diego, California, United States
31107
🇺🇸Metairie, Louisiana, United States
31123
🇺🇸Birmingham, Alabama, United States
31142
🇺🇸Port Jefferson, New York, United States
31139
🇺🇸Lauderdale Lakes, Florida, United States
31106
🇺🇸Wellington, Florida, United States
31111
🇺🇸Norcross, Georgia, United States
31114
🇺🇸Lawrenceville, New Jersey, United States
31103
🇺🇸Las Vegas, Nevada, United States
31146
🇺🇸Covington, Louisiana, United States
31120
🇺🇸Bristol, Tennessee, United States
31113
🇺🇸Richmond, Virginia, United States
31116
🇺🇸Morehead City, North Carolina, United States
31125
🇺🇸Franklin, Ohio, United States
31117
🇺🇸Draper, Utah, United States
31127
🇺🇸West Seneca, New York, United States
31144
🇺🇸Raleigh, North Carolina, United States
31147
🇺🇸Fall River, Massachusetts, United States
31145
🇺🇸Winston-Salem, North Carolina, United States