A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
VIOLET
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oteseconazole (VT-1161) Oral Capsules in the Treatment of Subjects With Recurrent Vulvovaginal Candidiasis
1 other identifier
interventional
438
1 country
25
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2018
Typical duration for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2018
CompletedFirst Posted
Study publicly available on registry
June 19, 2018
CompletedStudy Start
First participant enrolled
August 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 19, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 6, 2021
CompletedResults Posted
Study results publicly available
January 13, 2022
CompletedFebruary 17, 2026
January 1, 2026
2.2 years
June 1, 2018
October 19, 2021
January 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
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)
Maintenance phase (post-randomization through Week 48)
Study Arms (2)
Oteseconazole (VT-1161) 150mg capsule
EXPERIMENTALOnce daily for 7 days starting at Day 1, followed by once weekly for 11 weeks
Placebo capsule
PLACEBO COMPARATOROnce daily for 7 days starting at Day 1, followed by once weekly for 11 weeks
Interventions
Oteseconazole (VT-1161) 150mg capsule
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
31123
Birmingham, Alabama, 35233, United States
31108
San Diego, California, 92111, United States
31139
Lauderdale Lakes, Florida, 33319, United States
31143
Sarasota, Florida, 34239, United States
31106
Wellington, Florida, 33414, United States
31111
Norcross, Georgia, 30095, United States
31146
Covington, Louisiana, 70433, United States
31105
Metairie, Louisiana, 70006, United States
31107
Metarie, Louisiana, 70001, United States
31147
Fall River, Massachusetts, 02720, United States
31118
Las Vegas, Nevada, 89123, United States
31103
Las Vegas, Nevada, 89128, United States
31114
Lawrenceville, New Jersey, 08648, United States
31142
Port Jefferson, New York, 11777, United States
31127
West Seneca, New York, 14224, United States
31132
Greensboro, North Carolina, 27408, United States
31116
Morehead City, North Carolina, 28557, United States
31144
Raleigh, North Carolina, 27607, United States
31145
Winston-Salem, North Carolina, 27103, United States
31125
Franklin, Ohio, 45005, United States
31134
Philadelphia, Pennsylvania, 19102, United States
31120
Bristol, Tennessee, 37620, United States
31102
Houston, Texas, 77054, United States
31117
Draper, Utah, 84020, United States
31113
Richmond, Virginia, 23225, United States
Related Publications (2)
Sobel JD, Donders G, Degenhardt T, Person K, Curelop S, Ghannoum M, Brand SR. Efficacy and Safety of Oteseconazole in Recurrent Vulvovaginal Candidiasis. NEJM Evid. 2022 Aug;1(8):EVIDoa2100055. doi: 10.1056/EVIDoa2100055. Epub 2022 Jul 26.
PMID: 38319878DERIVEDVanreppelen G, Nysten J, Baldewijns S, Sillen M, Donders G, Van Dijck P. Oteseconazole (VIVOJA) for prevention of recurrent vulvovaginal candidiasis. Trends Pharmacol Sci. 2023 Jan;44(1):64-65. doi: 10.1016/j.tips.2022.10.004. Epub 2022 Nov 14. No abstract available.
PMID: 36396498DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Administration
- Organization
- Mycovia Pharmaceuticals Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2018
First Posted
June 19, 2018
Study Start
August 16, 2018
Primary Completion
October 19, 2020
Study Completion
August 6, 2021
Last Updated
February 17, 2026
Results First Posted
January 13, 2022
Record last verified: 2026-01