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

Cisen Pharmaceutical CO., LTD.

Status and phase: Enrolling; Phase 2

Conditions: Vaginitis

Treatments: Drug: fluconazole capsules/placebo; Drug: WXSH0102/placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06771063

WXSH0102-02-001

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 4 patient groups

Arm A : WXSH0102 Day1 1400 mg Day2-3 700

Experimental group

Description:

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

Treatment:

Drug: WXSH0102/placebo

Arm B : WXSH0102 Day1 1000 mg Day2-3 500 arm

Experimental group

Description:

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

Treatment:

Drug: WXSH0102/placebo

C : WXSH0102 Day1 600 mg Day2-3 300

Experimental group

Description:

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

Treatment:

Drug: WXSH0102/placebo

Arm D: fluconazole

Active Comparator group

Description:

Arm D (active control group) will receive fluconazole capsules for only one day on D1

Treatment:

Drug: fluconazole capsules/placebo