A Phase 2, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Miconazole Nitrate 2% + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 90
- 试验地点
- 6
- 主要终点
- The proportion of subjects with clinical cure
研究概览
简要总结
This study is a multicentre, three-arm, double-blind, randomized controlled, parallel-group, comparative phase II clinical trial to evaluate miconazole nitrate 2% + domiphen bromide vaginal cream in subjects with acute vulvovaginal candidiasis.
详细描述
Females aged 18-50 years with a clinical diagnosis of an acute VVC episode at Screening Visit will be randomly assigned to either miconazole nitrate 2% + low or high dose of domiphen bromide vaginal cream or to the comparator product Gyno-Daktarin® vaginal cream (miconazole nitrate 2%). The creams will be applied for 7 days and subjects will be followed up for 12 weeks.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Miconazole Nitrate 2% + Domiphen Bromide Low Dose Vaginal Cream
The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days.
干预措施: Miconazole Nitrate 2% + Domiphen Bromide Low Dose (Drug)
Miconazole Nitrate 2% + Domiphen Bromide High Dose Vaginal Cream
The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days.
干预措施: Miconazole Nitrate 2% + Domiphen Bromide High Dose (Drug)
Gyno-Daktarin® Vaginal Cream
The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days.
干预措施: Miconazole Nitrate 2% (Drug)
结局指标
主要结局
The proportion of subjects with clinical cure
时间窗: First follow-up visit (Day 15)
Resolution of the VVC signs and symptoms that were present at Screening Visit (Baseline)
The proportion of subjects with overall therapeutic success
时间窗: First follow-up visit (Day 15)
Achievement of both clinical cure and mycological eradication
The proportion of subjects with mycological eradication
时间窗: First follow-up visit (Day 15)
A culture negative vaginal swab for growth of baseline Candida species
次要结局
- The proportion of subjects with mycological eradication(First follow-up visit through Week 12)
- The proportion of subjects with overall therapeutic success(First follow-up visit through Week 12)
- Change from Baseline in vulvovaginitis symptom questionnaire total score(Through Week 12)
- The proportion of subjects with clinical cure(First follow-up visit through Week 12)
- Change from Baseline in the EQ-5D questionnaire total score(Through Week 12)