Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections
NCT ID: NCT03840616
Last Updated: 2022-02-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
219 participants
INTERVENTIONAL
2019-03-13
2020-12-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
NCT03562156
A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
NCT03561701
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Acute Vaginal Candidiasis (Yeast Infection)
NCT01891331
A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
NCT02267382
Oteseconazole in the Treatment of Adults With Vulvovaginal Candidiasis（VVC）
NCT07044947
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Oteseconazole (VT-1161) 150mg capsule
600mg oteseconazole administered on Day 1 and 450mg administered on Day 2, followed by 150mg administered once weekly for 11 weeks staring on Day 14
Oteseconazole (VT-1161) 150mg capsule
600mg 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
150mg fluconazole administered every 72 hours in 3 sequential doses starting on Day 1, followed by placebo administered once weekly starting on Day 14
Fluconazole 150mg capsule
150mg administered every 72 hours in 3 sequential doses starting on Day 1.
Placebo
Administered once weekly starting on Day 14.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Oteseconazole (VT-1161) 150mg capsule
600mg 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
150mg administered every 72 hours in 3 sequential doses starting on Day 1.
Placebo
Administered once weekly starting on Day 14.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
12 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mycovia Pharmaceuticals Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
34
Tucson, Arizona, United States
39
Encino, California, United States
25
Los Angeles, California, United States
22
Englewood, Colorado, United States
49
Boca Raton, Florida, United States
14
Gainesville, Florida, United States
13
Leesburg, Florida, United States
33
Loxahatchee Groves, Florida, United States
36
Miami, Florida, United States
17
Savannah, Georgia, United States
27
Idaho Falls, Idaho, United States
10
Nampa, Idaho, United States
62
Chicago, Illinois, United States
41
Fort Wayne, Indiana, United States
30
Marrero, Louisiana, United States
50
Dearborn Heights, Michigan, United States
29
Saginaw, Michigan, United States
55
Traverse City, Michigan, United States
32
Troy, Michigan, United States
26
Kansas City, Missouri, United States
42
New Brunswick, New Jersey, United States
47
Ocean City, New Jersey, United States
37
Charlotte, North Carolina, United States
38
Fayetteville, North Carolina, United States
15
Columbus, Ohio, United States
18
Bluffton, South Carolina, United States
48
Myrtle Beach, South Carolina, United States
20
Bristol, Tennessee, United States
21
Murfreesboro, Tennessee, United States
24
Austin, Texas, United States
23
Fort Worth, Texas, United States
63
Katy, Texas, United States
58
League City, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VMT-VT-1161-CL-017
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.