Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)
NCT ID: NCT03734991
Last Updated: 2021-09-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
376 participants
INTERVENTIONAL
2019-01-04
2019-09-04
Brief Summary
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Detailed Description
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* Oral ibrexafungerp 300-mg dose BID for 1 day
* Oral ibrexafungerp matching placebo BID for 1 day
Subjects will receive their first dose of study drug at the site and will be dispensed the second dose for self-administration at home 12 hours after the first dose. Study Blinding, Randomization and Stratification: This is a randomized, double-blind study.
All site and sponsor personnel will be blinded to treatment assignment. Approximately 366 eligible subjects will be enrolled and randomized in a 2:1 ratio to one of the two study treatment groups. For the purpose of maintaining treatment blinding, all subjects randomized to the placebo group will receive matching ibrexafungerp placebo tablets.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ibrexafungerp (SCY-078)
300 mg orally every 12 hrs for 1 day (2 doses in 1 day)
Ibrexafungerp
Ibrexafungerp 300 mg BID for 1 day
Placebo
Matching Placebo
Placebo
Matching placebo
Interventions
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Ibrexafungerp
Ibrexafungerp 300 mg BID for 1 day
Placebo
Matching placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Subject has a diagnosis of symptomatic AVVC at baseline including a positive microscopic examination with 10% KOH in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)
Exclusion Criteria
Need for systemic and/or topical (vaginal) antifungal treatment, including prescription or over-the-counter products during the study and treatment for VVC 28 days prior to randomization
Subject is actively menstruating at the time of the Baseline visit.
Subject has uncontrolled diabetes mellitus.
Subject has a vaginal sample with pH \>4.5.
Subject has a history of or an active cervical/vaginal cancer.
12 Years
FEMALE
No
Sponsors
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Scynexis, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Angulo, MD
Role: STUDY_DIRECTOR
Scynexis, Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Precision Trials AZ, LLC
Phoenix, Arizona, United States
Womens' Health Care Research Corp
San Diego, California, United States
Women's Medical Research Group
Clearwater, Florida, United States
Altus Research
Lake Worth, Florida, United States
OBGYN Assoc of Mid Florida
Leesburg, Florida, United States
New Age Medical Research Corporation
Miami, Florida, United States
Clinical Trials Management LLC
Covington, Louisiana, United States
Clinical Trials Management LLC
Metairie, Louisiana, United States
Unified Women's Clinical Research- Hagerstown
Hagerstown, Maryland, United States
Wayne State University
Detroit, Michigan, United States
Consultants In Women's Healthcare, Inc.
St Louis, Missouri, United States
Center For Women's Health and Wellness LLC - Interspond - PPDS
Lawrenceville, New Jersey, United States
Lawrence OB/GYN Clinical Research, LLC
Lawrenceville, New Jersey, United States
GYN Center for Women PA
Durham, North Carolina, United States
Carolina Women's Research and Wellness Center
Durham, North Carolina, United States
Unified Women's Clinical Research Greensboro
Greensboro, North Carolina, United States
Unified Women's Clinical Research
Morehead City, North Carolina, United States
Unified Women's Clinical Research Raleigh
Raleigh, North Carolina, United States
Unified Women's Clinical Research - Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
Medical Research South
Charleston, South Carolina, United States
Magnolia Ob/Gyn Research Center, LLC
Myrtle Beach, South Carolina, United States
Medical Research Center of Memphis
Memphis, Tennessee, United States
TMC Life Research Inc
Houston, Texas, United States
Group For Women
Norfolk, Virginia, United States
Countries
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References
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Goje O, Sobel R, Nyirjesy P, Goldstein SR, Spitzer M, Faught B, Larson S, King T, Azie NE, Angulo D, Sobel JD. Oral Ibrexafungerp for Vulvovaginal Candidiasis Treatment: An Analysis of VANISH 303 and VANISH 306. J Womens Health (Larchmt). 2023 Feb;32(2):178-186. doi: 10.1089/jwh.2022.0132. Epub 2022 Oct 17.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SCY-078-303
Identifier Type: -
Identifier Source: org_study_id
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