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

NCT06771063 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-02-13

No results posted yet for this study

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

DRUG

WXSH0102/placebo

Administer WXSH0102 tablets/placebo orally.

DRUG

fluconazole capsules/placebo

Administer fluconazole capsules/placebo orally

Sponsors & Collaborators

  • Cisen Pharmaceutical CO., LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-13
Primary Completion
2025-07-10
Completion
2025-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06771063 on ClinicalTrials.gov