Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections
ultraVIOLET
Phase 3, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oteseconazole (VT-1161) Oral Capsules vs Fluconazole and Placebo in Treatment of Acute Vulvovaginal Candidiasis in Subjects With Recurrent Vulvovaginal Candidiasis
1 other identifier
interventional
219
1 country
33
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2019
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2019
CompletedFirst Posted
Study publicly available on registry
February 15, 2019
CompletedStudy Start
First participant enrolled
March 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2020
CompletedResults Posted
Study results publicly available
February 4, 2022
CompletedFebruary 4, 2022
November 1, 2021
1.7 years
February 11, 2019
November 29, 2021
February 3, 2022
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 (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)
48 Weeks
Study Arms (2)
Oteseconazole (VT-1161) 150mg capsule
EXPERIMENTAL600mg oteseconazole administered on Day 1 and 450mg administered on Day 2, followed by 150mg administered once weekly for 11 weeks staring on Day 14
Fluconazole 150mg capsule / Placebo
ACTIVE COMPARATOR150mg fluconazole administered every 72 hours in 3 sequential doses starting on Day 1, followed by placebo administered once weekly starting on Day 14
Interventions
600mg administered on Day 1 and 450mg administered on Day 2, followed by 150mg administered once weekly for 11 weeks staring on Day 14.
150mg administered every 72 hours in 3 sequential doses starting on Day 1.
Eligibility Criteria
You may qualify if:
- 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
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 (33)
34
Tucson, Arizona, 85712, United States
39
Encino, California, 91436, United States
25
Los Angeles, California, 90036, United States
22
Englewood, Colorado, 80112, United States
49
Boca Raton, Florida, 33486, United States
14
Gainesville, Florida, 32607, United States
13
Leesburg, Florida, 34748, United States
33
Loxahatchee Groves, Florida, 33470, United States
36
Miami, Florida, 33155, United States
17
Savannah, Georgia, 31406, United States
27
Idaho Falls, Idaho, 83404, United States
10
Nampa, Idaho, 83687, United States
62
Chicago, Illinois, 60643, United States
41
Fort Wayne, Indiana, 46825, United States
30
Marrero, Louisiana, 70072, United States
50
Dearborn Heights, Michigan, 48127, United States
29
Saginaw, Michigan, 48602, United States
55
Traverse City, Michigan, 49686, United States
32
Troy, Michigan, 48085, United States
26
Kansas City, Missouri, 64111, United States
42
New Brunswick, New Jersey, 08901, United States
47
Ocean City, New Jersey, 07712, United States
37
Charlotte, North Carolina, 28207, United States
38
Fayetteville, North Carolina, 28304, United States
15
Columbus, Ohio, 43213, United States
18
Bluffton, South Carolina, 29910, United States
48
Myrtle Beach, South Carolina, 29572, United States
20
Bristol, Tennessee, 37620, United States
21
Murfreesboro, Tennessee, 37130, United States
24
Austin, Texas, 78705, United States
23
Fort Worth, Texas, 76104, United States
63
Katy, Texas, 77450, United States
58
League City, Texas, 77573, United States
Related Publications (1)
Vanreppelen 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)
Intervention 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
February 11, 2019
First Posted
February 15, 2019
Study Start
March 13, 2019
Primary Completion
December 2, 2020
Study Completion
December 2, 2020
Last Updated
February 4, 2022
Results First Posted
February 4, 2022
Record last verified: 2021-11