Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
NCT ID: NCT04029116
Last Updated: 2023-06-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
440 participants
INTERVENTIONAL
2019-10-21
2021-11-29
Brief Summary
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Detailed Description
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Subjects who fail treatment with fluconazole for their acute episode will be included in a nested open label Sub-Study, in which they will be offered one-day oral ibrexafungerp for their unresolved acute episode.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Ibrexafungerp
Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Ibrexafungerp 300 mg BID (one day) every 4 weeks for a total of 6 dosing days
Fluconazole Tablet
150 mg every 72 hours for 3 doses
IBREXAFUNGERP
300 mg BID (one day) every 4 weeks for a total of 6 dosing days
Placebo
Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Placebo BID (one day) every 4 weeks for a total of 6 dosing days
Fluconazole Tablet
150 mg every 72 hours for 3 doses
Placebo oral tablet
BID (one day) every 4 weeks for a total of 6 dosing days
Interventions
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Fluconazole Tablet
150 mg every 72 hours for 3 doses
IBREXAFUNGERP
300 mg BID (one day) every 4 weeks for a total of 6 dosing days
Placebo oral tablet
BID (one day) every 4 weeks for a total of 6 dosing days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of 3 or more episodes of VVC in the past 12 months.
* Culture confirmation and resolution of the signs and symptoms of the initial VVC episode (with treatment).
* Able to take oral tablets and capsules.
Exclusion Criteria
* Recent use of systemic and/or topical vaginal antifungal products.
* Pregnant.
* History of major system organ disease.
12 Years
FEMALE
No
Sponsors
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Scynexis, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nkechi Azie, MD
Role: STUDY_DIRECTOR
Scynexis, Inc.
Locations
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Precision Trials LLC
Phoenix, Arizona, United States
Women's Healthcare Research Corp
San Diego, California, United States
Altus Research - Hunt - PPDS
Lake Worth, Florida, United States
New Age Medical Research Corporation
Miami, Florida, United States
Healthcare Clinical Data Inc
North Miami, Florida, United States
Clinical Research Prime - ClinEdge - PPDS
Idaho Falls, Idaho, United States
Clinical Trials Management
Covington, Louisiana, United States
Women Under Study, LLC
New Orleans, Louisiana, United States
Unified Women's Clinical Research
Hagerstown, Maryland, United States
Wayne State University
Detroit, Michigan, United States
Center For Women's Health and Wellness LLC
Lawrenceville, New Jersey, United States
Lawrence Obstetrics Gynecology Clinical Research LLC
Lawrenceville, New Jersey, United States
Bosque Women's Care
Albuquerque, New Mexico, United States
Carolina Women's Research and Wellness Center
Durham, North Carolina, United States
Unified Womens CLinical Research
Greensboro, North Carolina, United States
Unified Women's Clinical Research Raleigh
Raleigh, North Carolina, United States
M3 Wake Research, Inc
Raleigh, North Carolina, United States
Group For Women
Winston-Salem, North Carolina, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Obstetrics and Gynecology Associates of Erie, PC
Erie, Pennsylvania, United States
Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Chattanooga Medical Research Inc
Chattanooga, Tennessee, United States
Medical Research Center of Memphis, LLC
Memphis, Tennessee, United States
TMC Life Research Inc
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SCY-078-304
Identifier Type: -
Identifier Source: org_study_id
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