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Clinical Trials in China / NCT06771063
Recruiting Phase 2

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

NCT06771063 · tracked via the Priya Life Science China tracker
Sponsor
Cisen Pharmaceutical CO., LTD.
Phase
Phase 2
Started
2025-01-13
Last updated
2025-02-13

Condition(s) studied

Vaginitis

Investigational drug(s) / intervention(s)

WXSH0102/placebofluconazole capsules/placebo

WXSH0102/placebo: Administer WXSH0102 tablets/placebo orally.

fluconazole capsules/placebo: Administer fluconazole capsules/placebo orally

Study 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
FEMALE
Min age
18 Years
Max age
64 Years
Healthy volunteers
Accepted
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;

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
251 Yaojiayuan Road, Chaoyang District, Beijing Beijing Beijing Municipality Not Yet Recruiting
Beijing Obstetrics and Gynecology Hospital Beijing Beijing Municipality Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06771063 on ClinicalTrials.gov ↗ ← All trials in China