Last updated on July 2019

Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis

Brief description of study

This is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in female subjects 12 years and older with AVVC.

Detailed Study Description

Subjects who meet all of the inclusion and none of the exclusion criteria will be enrolled into the study and will be randomized in a 2:1 ratio to either oral ibrexafungerp or ibrexafungerp matching placebo, as follows:

  • 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.

Clinical Study Identifier: NCT03734991

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Precision Trials AZ, LLC

Phoenix, AZ United States
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Altus Research

Lake Worth, FL United States
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OBGYN Assoc of Mid Florida

Leesburg, FL United States
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Clinical Trials Management LLC

Covington, LA United States
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GYN Center for Women PA

Durham, NC United States
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Medical Research South

Charleston, SC United States
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TMC Life Research Inc

Houston, TX United States
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Women's Medical Research Group

Clearwater, FL United States
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Wayne State University

Detroit, MI United States
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Unified Women's Clinical Research

Morehead City, NC United States
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Group For Women

Norfolk, VA United States
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Recruitment Status: Open

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