Multi-center, Randomized, Placebo-controlled, Parallel-group, Double-blinded Study to Compare the Therapeutic Efficacy, Safety, and Tolerability of 3 Single Vaginal Doses of Arasertaconazole Nitrate Pessaries in the Treatment of VVC
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 229
- 试验地点
- 1
- 主要终点
- Dose-response of Clinical and Mycological (Global) Therapeutic Response
研究概览
简要总结
In order to find an optimal dose of arasertaconazole nitrate in the treatment of vulvovaginal candidiasis, a multicenter, randomized, double-blind, parallel, placebo-controlled study will be conducted to compare the therapeutic efficacy, safety and tolerability of three different doses of arasertaconazole nitrate (150 mg, 300 mg or 600 mg, pessaries).
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged between 18 to 65 years of age who have signed the informed consent.
- •Not pregnant, not nursing.
- •No indication of other vulvovaginitis or genital infections
- •Positive 10% potassium hydroxide (KOH) preparation for budding yeast and/or pseudohyphae.
- •Negative wet mount results for T. vaginalis and clue cells.
排除标准
- •Subjects with another vaginal or vulvar condition that would confound the interpretation of clinical response.
- •Hypersensitivity to imidazole products administered topically.
- •Any other medical condition which in the opinion of the investigator could interfere with study conduct.
研究组 & 干预措施
arasertaconazole 600 mg
Arasertaconazole nitrate 600 mg pessary, single dose
干预措施: placebo (Drug)
Arasertaconazole nitrate 150 mg
Arasertaconazole nitrate 150 mg pessary, single dose
干预措施: placebo (Drug)
arasertaconazole nitrate 300 mg
Arasertaconazole nitrate 300 mg pessary, single dose
干预措施: placebo (Drug)
arasertaconazole nitrate 300 mg
Arasertaconazole nitrate 300 mg pessary, single dose
干预措施: arasertaconazole nitrate (Drug)
Arasertaconazole nitrate 150 mg
Arasertaconazole nitrate 150 mg pessary, single dose
干预措施: arasertaconazole nitrate (Drug)
arasertaconazole 600 mg
Arasertaconazole nitrate 600 mg pessary, single dose
干预措施: arasertaconazole nitrate (Drug)
placebo
placebo pessary, single dose
干预措施: arasertaconazole nitrate (Drug)
结局指标
主要结局
Dose-response of Clinical and Mycological (Global) Therapeutic Response
时间窗: day 26 ± 4 days
Global therapeutic response at day 26± 4 days ("TOC"- Test-of-Cure visit).Global therapeutic response is a composite endpoint using the clinical (signs and symptoms) and the mycological cures (microbiological culture), according to FDA guideline "Vulvovaginal Candidiasis -Developing Antimicrobial Drugs for Treatment".
次要结局
- Dose-response of Clinical and Mycological (Global)Therapeutic Response(Day 8 ± 2 days)