Efficacy and safety of oral ibrexafungerp for the treatment of acute vulvovaginal candidiasis: a global phase 3, randomised, placebo-controlled superiority study (VANISH 306).

ABSTRACT:

Objective

To evaluate the efficacy and safety of ibrexafungerp versus placebo for acute vulvovaginal candidiasis (VVC) treatment.

Design

Global phase 3, randomised, placebo-controlled superiority study.

Setting

Study sites in the USA (n = 19) and Bulgaria (n = 18).

Population

Female patients aged ≥12 years with acute VVC and a vulvovaginal signs and symptoms (VSS) score ≥4 at baseline.

Methods

Patients were randomly assigned 2:1 to ibrexafungerp (300 mg twice for 1 day) or placebo.

Main outcome measures

The primary endpoint was the percentage of patients with a clinical cure (VSS = 0) at the test-of-cure visit (day 11 ± 3). Secondary endpoints included percentages of patients with mycological eradication, clinical cure and mycological eradication

SUBMITTER: Sobel R 

PROVIDER: S-EPMC9299454 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature