Phase 3
N=219
Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections
Recurrent Vulvovaginal Candidiasis
Bottom Line
View on ClinicalTrials.gov: NCT03840616 ↗Enrolled (actual)
219
Serious AEs
1.0%
Results posted
Feb 2022
Primary outcome: Primary: 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 — 5.1; 42.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Oteseconazole (VT-1161) 150mg capsule (Drug); Fluconazole 150mg capsule (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- Female
- Sponsor
- Mycovia Pharmaceuticals Inc.
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
5.1; 42.2 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03840616). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.