A Multicenter, Randomized, Double-blind, Positive-controlled Study to Evaluate the Efficacy and Safety of WXSH0102 Tablets in Treating Vulvovaginal Candidiasis

What this Trial Is About

Researchers are evaluating the effectiveness and safety of an investigational drug called WXSH0102 compared to the active drug fluconazole for treating vulvovaginal candidiasis (VVC). This multicenter, randomized, double-blind, active-controlled, dose-ranging Phase II clinical trial involves female patients aged 18 to 64 years who have been diagnosed with VVC. The study aims to determine which dosing regimen of WXSH0102 might best treat this condition by comparing it with fluconazole, a standard treatment. Participants are randomly assigned to one of four groups: three groups receive different doses of WXSH0102 tablets—1400 mg on the first day followed by 700 mg on days 2 and 3; 1000 mg followed by 500 mg; or 600 mg followed by 300 mg—and the fourth group receives a single dose of fluconazole capsules on day 1. All medications are given orally during a treatment period lasting three days. The study consists of three phases: screening and enrollment before treatment, the treatment period from day 1 to day 3, and a follow-up period with visits on days 4, 11 (plus or minus 2 days), and 25 (plus or minus 3 days). During the study, participants will be assessed for cure rates, clinical improvement, and clearance of the fungal infection at follow-up visits, particularly on day 11 and day 25. Researchers will also monitor vaginal health, adverse events, and drug concentration levels in the body. Participants agree to avoid sexual activity and use condoms throughout the study. The total study duration includes screening, treatment, and follow-up visits over approximately 25 days from the first treatment dose.

A Study of the Efficacy and Safety of WXSH0102 in Treating VCC Patients