Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)
Summary
Linked Publications
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Oral Ibrexafungerp for Vulvovaginal Candidiasis Treatment: An Analysis of VANISH 303 and VANISH 306.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Cure (Complete Resolution of Signs and Symptoms) |
95; 28; 93; 70 | — |
| SECONDARY Mycological Eradication (Negative Culture for Growth of Yeast) |
93; 19; 95; 79 | — |
| SECONDARY Clinical Cure and Mycological Eradication (Responder Outcome) |
64; 12; 114; 83 | — |
| SECONDARY Complete Clinical Response at Follow-Up |
113; 44; 77; 56 | — |
| SECONDARY Overall Treatment-Emergent Adverse Events (Safety Set) |
98; 21; 149; 103 | — |
Eligibility 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% 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) 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.
Data sourced from ClinicalTrials.gov (NCT03734991) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.