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NCT Number: NCT06771063

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

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.

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Key information

Conditions

Vaginitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vaginal Diseases

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

251 Yaojiayuan Road, Chaoyang District, Beijing, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

WXSH0102/placebo

Drug

Administer WXSH0102 tablets/placebo orally.

fluconazole capsules/placebo

Drug

Administer fluconazole capsules/placebo orally

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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;

  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;

  3. 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

  4. 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

  5. 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..

  6. 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;

  7. 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

  8. Proportion of subjects requiring rescue therapy during the trial;

    Time frame: Day 25±3

    Proportion of subjects requiring rescue therapy during the trial;

  9. 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

  10. adverse events

    Time frame: Day 25±3

    Incidence and severity of adverse events and serious adverse events

  11. AUC0-tau

    Time frame: day 4

    the AUC0-tau estimated using non-compartmental and/or population pharmacokinetic models

  12. Cmax

    Time frame: day 4

    the Cmax estimated using non-compartmental and/or population pharmacokinetic models

Study contacts

Contact information is provided by the study sponsor or research team.

Zhaohui Liu, professor

CONTACT

[email protected]

13701118639

Sponsors and collaborators

Lead sponsor

Cisen Pharmaceutical CO., LTD.

Industry

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2025
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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