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)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Proportion of subjects achieving cure at the D11±2 visit.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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;
研究组 & 干预措施
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
干预措施: WXSH0102/placebo (Drug)
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
干预措施: WXSH0102/placebo (Drug)
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
干预措施: WXSH0102/placebo (Drug)
Arm D: fluconazole
Arm D (active control group) will receive fluconazole capsules for only one day on D1
干预措施: fluconazole capsules/placebo (Drug)
结局指标
主要结局
Proportion of subjects achieving cure at the D11±2 visit.
时间窗: 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.
次要结局
- Proportion of subjects achieving clinical cure at the D11±2 visit(day 11±2)
- Proportion of subjects achieving mycological clearance at the D11±2 visit(day 11±2)
- Proportion of subjects achieving clinical improvement at the D11±2 visit(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.(Day 25±3)
- Proportion of subjects achieving mycological clearance at the D25±3 visit(Day 25±3)
- Proportion of subjects achieving clinical improvement at the D25±3 visit(Day 25±3)
- Proportion of subjects requiring rescue therapy during the trial;(Day 25±3)
- Proportion of subjects with normal vaginal microecology assessments(Day11±2 and day 25±3)
- adverse events(Day 25±3)
- AUC0-tau(day 4)
- Cmax(day 4)