Status:
COMPLETED
Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
Lead Sponsor:
Scynexis, Inc.
Conditions:
Recurrent Vulvovaginal Candidiasis
Eligibility:
FEMALE
12+ years
Phase:
PHASE3
Brief Summary
This study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female su...
Detailed Description
This study is a Phase 3, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and ...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria:
- Diagnosis of symptomatic VVC with microscopic examination with KOH positive for yeast and normal vaginal pH.
- 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.
- Key exclusion Criteria:
- Vaginal conditions other than recurrent VVC that may interfere with the diagnosis or evaluation of response to therapy.
- Recent use of systemic and/or topical vaginal antifungal products.
- Pregnant.
- History of major system organ disease.
Exclusion
Key Trial Info
Start Date :
October 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2021
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT04029116
Start Date
October 21 2019
End Date
November 29 2021
Last Update
June 18 2023
Active Locations (25)
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1
Precision Trials LLC
Phoenix, Arizona, United States, 85032
2
Women's Healthcare Research Corp
San Diego, California, United States, 92111
3
Altus Research - Hunt - PPDS
Lake Worth, Florida, United States, 33461
4
New Age Medical Research Corporation
Miami, Florida, United States, 33186