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)

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.

Study Overview

• Status: Recruiting
• Conditions: Vaginitis
• Intervention / Treatment: Drug: WXSH0102/placebo; Drug: fluconazole capsules/placebo

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: zhaohui liu, professor; Phone Number: 13701118639; Email: 23662161@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100025
      • Not yet recruiting
      • 251 Yaojiayuan Road, Chaoyang District, Beijing
      • Contact: zhaohui liu, professor; Phone Number: 13701118639; Email: 23662161@qq.com
    • Beijing, Beijing, China, 100025
      • Recruiting
      • Beijing obstetrics and gynecology hospital
      • Contact: hui zhao liu; Phone Number: 13701118639; Email: 23662161@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• The subjects understood and voluntarily signed the informed consent Form (ICF), and were willing and able to comply with the study protocol.
• Female participants who signed ICF at the age of 18-64 years (including the cut-off value) and had sexual intercourse;
• Participants were diagnosed with VVC and met each of the following criteria: a. At screening, the total score on the VVC scale was ≥4 and at least two of the symptoms or signs on the VVC scale were present; b. A vaginal discharge sample collected at screening was Gram stain positive for Candida (hypha/pseudohypha/budding); c. Vaginal pH ≤4.5; Symptoms: vulvovaginal itching, vulvar burning pain, dyspareunia and urination pain, excessive secretion, secretion is tofu residue like; Physical signs: gynecological examination showed vulvar hyperemia and edema, which may be accompanied by scratches. In severe cases, chapped skin, exfoliation and even erosion could be seen. Vaginal mucosa was hyperemic, vaginal secretion was curd or tofu residue like;
• Subjects who are capable of oral administration;
• For the duration of the study, participants agreed to abstain from sexual activity and to use the condom throughout sexual activity.

Exclusion Criteria:

• Known or suspected allergic history to any component of this product, fluconazole or pyrrole drugs;
• Subjects with any vulvovaginal or cervical disease that may affect the diagnosis and evaluation of VVC;
• Topical or systemic antifungal treatment for VVC within 14 days before randomization;
• Significant liver disease or abnormal liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST] > 1.5 ULN); Patients with severe renal disease or renal insufficiency (glomerular filtration rate (GFR) < 60ml/min/1.73m2 );
• Patients who planned to undergo treatment or surgery for vulvar, vaginal or cervical lesions during the study period;
• Severe gastrointestinal disease or other conditions that may affect the absorption of the trial drug;
• Patients with severe heart, lung, liver, kidney dysfunction and hematopoietic system diseases;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A : WXSH0102 Day1 1400 mg Day2-3 700; Arm A will receive WXSH0102 tablets with a loading dose of 1400 mg on the first day followed by a maintenance dose of 700 mg for two consecutive days	Drug: WXSH0102/placebo; Administer WXSH0102 tablets/placebo orally.
Experimental: Arm B : WXSH0102 Day1 1000 mg Day2-3 500 arm; Arm B will receive WXSH0102 tablets with a loading dose of 1000 mg on the first day followed by a maintenance dose of 500 mg for two consecutive days	Drug: WXSH0102/placebo; Administer WXSH0102 tablets/placebo orally.
Experimental: C : WXSH0102 Day1 600 mg Day2-3 300; Arm C will receive WXSH0102 tablets with a loading dose of 600 mg on the first day followed by a maintenance dose of 300 mg for two consecutive days	Drug: WXSH0102/placebo; Administer WXSH0102 tablets/placebo orally.
Active Comparator: Arm D: fluconazole; Arm D (active control group) will receive fluconazole capsules for only one day on D1	Drug: fluconazole capsules/placebo; Administer fluconazole capsules/placebo orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects achieving cure at the D11±2 visit.	Proportion of subjects achieving cure (defined as the disappearance of VVC symptoms and signs along with a negative Candida culture) at the D11±2 visit.	day 11±2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects achieving clinical cure at the D11±2 visit	Proportion of subjects achieving clinical cure (complete disappearance of VVC symptoms and signs) at the D11±2 visit;	day 11±2
Proportion of subjects achieving mycological clearance at the D11±2 visit	Proportion of subjects achieving mycological clearance (negative growth of Candida species in fungal culture) at the D11±2 visit;	day 11±2
Proportion of subjects achieving clinical improvement at the D11±2 visit	Proportion of subjects achieving clinical improvement (partial or complete resolution of symptoms and signs, with a total VVC scale score ≤1) at the D11±2 visit	day 11±2
Difference in VVC scale scores between the D11±2 visit and baseline visit	Difference in VVC scale scores between the D11±2 visit and baseline visit	day 11±2
Proportion of subjects achieving cure at the D25±3 visit.	Proportion of subjects achieving cure (defined as the disappearance of VVC symptoms and signs along with a negative Candida culture) at the D25±3 visit..	Day 25±3
Proportion of subjects achieving mycological clearance at the D25±3 visit	Description: Proportion of subjects achieving mycological clearance (negative growth of Candida species in fungal culture) at the D25±3 visit;	Day 25±3
Proportion of subjects achieving clinical improvement at the D25±3 visit	Description: Proportion of subjects achieving clinical improvement (partial or complete resolution of symptoms and signs, with a total VVC scale score ≤1) at the D25±3visit	Day 25±3
Proportion of subjects requiring rescue therapy during the trial;	Proportion of subjects requiring rescue therapy during the trial;	Day 25±3
Proportion of subjects with normal vaginal microecology assessments	Proportion of subjects with normal vaginal microecology assessments at the D11±2 and D25±3 visits	Day11±2 and day 25±3
adverse events	Incidence and severity of adverse events and serious adverse events	Day 25±3
AUC0-tau	the AUC0-tau estimated using non-compartmental and/or population pharmacokinetic models	day 4
Cmax	the Cmax estimated using non-compartmental and/or population pharmacokinetic models	day 4

Collaborators and Investigators

• Sponsor: Cisen Pharmaceutical CO., LTD.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2025
• Primary Completion (Estimated): July 10, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: December 25, 2024
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Vaginal Diseases; Vaginitis; Anti-Infective Agents; Antifungal Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Steroid Synthesis Inhibitors; Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Fluconazole
• Other Study ID Numbers: WXSH0102-02-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No