NCT06771063

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

A Multicenter, Randomized, Double-blind, Positive-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of WXSH0102 Tablets in the Treatment of Vulvovaginal Candidiasis (VVC)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Cisen Pharmaceutical CO., LTD. · Industry
• Sex: Female
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This study is a multicenter, randomized, double-blind, active-controlled, dose-ranging clinical trial designed to evaluate the efficacy and safety of the investigational drug compared to the active comparator in the treatment of vulvovaginal candidiasis. The trial consists of three phases: screening/enrollment (D-3 to D-1), treatment period (D1 to D3), and follow-up period (D4, D11±2, D25±3). Eligible subjects in this study will be randomized in a 1:1:1:1 ratio to three investigational drug arms with different dosing regimens and one active control arm. Specifically, Group A will receive WXSH0102 tablets with 1400 mg on the first day followed by a maintenance dose of 700 mg for two consecutive days, Group B will receive WXSH0102 tablets with 1000 mg on the first day followed by a maintenance dose of 500 mg for two consecutive days, Group C will receive WXSH0102 tablets with 600 mg on the first day followed by a maintenance dose of 300 mg for two consecutive days, and Group D (active control group) will receive fluconazole capsules for only one day on D1. All medications will be administered orally.

Conditions

• Vaginitis

Interventions

Type	Name	Description
DRUG	WXSH0102/placebo	Administer WXSH0102 tablets/placebo orally.
DRUG	fluconazole capsules/placebo	Administer fluconazole capsules/placebo orally

Timeline

• Start date: 2025-01-13
• Primary completion: 2025-07-10
• Completion: 2025-07-31
• First posted: 2025-01-13
• Last updated: 2025-02-13

Locations

2 sites across 1 country: China