Status:
COMPLETED
Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
Lead Sponsor:
Scynexis, Inc.
Conditions:
Candida Vulvovaginitis
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This is a multicenter, randomized, double-blind, double-dummy, active-controlled, dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus oral fluconazole in adult f...
Detailed Description
This is a Phase 2, multicenter, randomized, double-blind, double-dummy, active-controlled, dose-ranging study of female subjects with moderate to severe Acute Vulvovaginal Candidiasis. Subjects will b...
Eligibility Criteria
Inclusion
- Key
- Subject is a female of at least 18 years of age
- 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)
- Key
Exclusion
- Subject has any vaginal condition other than AVVC that may interfere with the diagnosis or evaluation of response to therapy, such as suspected or confirmed concurrent causes of vulvovaginitis and/or cervicitis (mixed infection)
- 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.
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2018
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT03253094
Start Date
August 1 2017
End Date
May 4 2018
Last Update
August 12 2021
Active Locations (25)
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1
UAB Personal Health Clinic
Birmingham, Alabama, United States, 35294
2
Precision Trials AZ, LLC
Phoenix, Arizona, United States, 85032
3
Women's Health Care Research Corp.
San Diego, California, United States, 92111
4
Gulf Coast Research Group, LLC
Brandon, Florida, United States, 33510