Status:

RECRUITING

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

Lead Sponsor:

Cisen Pharmaceutical CO., LTD.

Conditions:

Vaginitis

Eligibility:

FEMALE

18-64 years

Phase:

PHASE2

Brief 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 co...

Eligibility Criteria

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;

Key Trial Info

Start Date :

January 13 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 31 2025

Estimated Enrollment :

108 Patients enrolled

Trial Details

Trial ID

NCT06771063

Start Date

January 13 2025

End Date

July 31 2025

Last Update

February 13 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

251 Yaojiayuan Road, Chaoyang District, Beijing

Beijing, Beijing Municipality, China, 100025

2

Beijing Obstetrics and Gynecology Hospital

Beijing, Beijing Municipality, China, 100025

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