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

February 11, 2025 updated by: Cisen Pharmaceutical CO., LTD.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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:
      • Beijing, Beijing, China, 100025
        • Recruiting
        • Beijing Obstetrics and Gynecology Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects achieving cure at the D11±2 visit.
Time Frame: day 11±2
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects achieving clinical cure at the D11±2 visit
Time Frame: day 11±2
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
Time Frame: day 11±2
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
Time Frame: day 11±2
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
Time Frame: day 11±2
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.
Time Frame: Day 25±3
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
Time Frame: Day 25±3
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
Time Frame: Day 25±3
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;
Time Frame: Day 25±3
Proportion of subjects requiring rescue therapy during the trial;
Day 25±3
Proportion of subjects with normal vaginal microecology assessments
Time Frame: Day11±2 and day 25±3
Proportion of subjects with normal vaginal microecology assessments at the D11±2 and D25±3 visits
Day11±2 and day 25±3
adverse events
Time Frame: Day 25±3
Incidence and severity of adverse events and serious adverse events
Day 25±3
AUC0-tau
Time Frame: day 4
the AUC0-tau estimated using non-compartmental and/or population pharmacokinetic models
day 4
Cmax
Time Frame: day 4
the Cmax estimated using non-compartmental and/or population pharmacokinetic models
day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cisen Pharmaceutical CO., LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 13, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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