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Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)

NCT03734991 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2021-09-08

Study results available
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Summary

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.

Conditions

  • Candida Vulvovaginitis

Interventions

DRUG

Ibrexafungerp

Ibrexafungerp 300 mg BID for 1 day

DRUG

Placebo

Matching placebo

Sponsors & Collaborators

  • Scynexis, Inc.

    lead INDUSTRY

Principal Investigators

  • David Angulo, MD · Scynexis, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-04
Primary Completion
2019-08-21
Completion
2019-09-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03734991 on ClinicalTrials.gov