RecruitingPhase 2NCT06771063

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)


Sponsor

Cisen Pharmaceutical CO., LTD.

Enrollment

108 participants

Start Date

Jan 13, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called WXSH0102/placebo and a drug called fluconazole capsules/placebo for people with vaginitis. The study is currently recruiting participants at 2 locations. People eligible for this study include women aged 18 Years to 64 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGWXSH0102/placebo

Administer WXSH0102 tablets/placebo orally.

DRUGfluconazole capsules/placebo

Administer fluconazole capsules/placebo orally


Locations(2)

251 Yaojiayuan Road, Chaoyang District, Beijing

Beijing, Beijing Municipality, China

Beijing Obstetrics and Gynecology Hospital

Beijing, Beijing Municipality, China

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NCT06771063


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