A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
NCT ID: NCT03562156
Last Updated: 2022-04-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
438 participants
INTERVENTIONAL
2018-08-16
2021-08-06
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Oteseconazole (VT-1161) 150mg capsule
Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks
Oteseconazole (VT-1161)
Oteseconazole (VT-1161) 150mg capsule
Placebo capsule
Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks
Placebo
matching placebo capsule
Interventions
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Oteseconazole (VT-1161)
Oteseconazole (VT-1161) 150mg capsule
Placebo
matching placebo capsule
Eligibility Criteria
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Inclusion Criteria
* 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
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
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Mycovia Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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31123
Birmingham, Alabama, United States
31108
San Diego, California, United States
31139
Lauderdale Lakes, Florida, United States
31143
Sarasota, Florida, United States
31106
Wellington, Florida, United States
31111
Norcross, Georgia, United States
31146
Covington, Louisiana, United States
31107
Metairie, Louisiana, United States
31105
Metairie, Louisiana, United States
31147
Fall River, Massachusetts, United States
31118
Las Vegas, Nevada, United States
31103
Las Vegas, Nevada, United States
31114
Lawrenceville, New Jersey, United States
31142
Port Jefferson, New York, United States
31127
West Seneca, New York, United States
31132
Greensboro, North Carolina, United States
31116
Morehead City, North Carolina, United States
31144
Raleigh, North Carolina, United States
31145
Winston-Salem, North Carolina, United States
31125
Franklin, Ohio, United States
31134
Philadelphia, Pennsylvania, United States
31120
Bristol, Tennessee, United States
31102
Houston, Texas, United States
31117
Draper, Utah, United States
31113
Richmond, Virginia, United States
Countries
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References
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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.
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
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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VMT-VT-1161-CL-011
Identifier Type: -
Identifier Source: org_study_id
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