Overview

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

Status:
Completed
Trial end date:
2020-04-29
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Scynexis, Inc.
Collaborator:
PPD
Treatments:
Ibrexafungerp
Criteria
Inclusion Criteria:

- Subject is a postmenarchal female subject 12 years and older

- Subject has a diagnosis of symptomatic AVVC at baseline including a positive
microscopic examination with 10% Potassium Hydroxide (KOH) in a vaginal sample
revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)

Exclusion Criteria:

- 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) anti fungal treatment, including
prescription or over-the-counter products during the study and treatment for
vulvovaginal candidiasis (VVC) 28 days prior to randomization.

- 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.