NCT00889356Unknown3 期
Phase III, Open Label, Randomized, Multicenter Study to Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, Compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream for the Treatment of Bacterial Vaginosis and Candidiasis Isolatedly or in Association (Mixed-Type Vaginosis)
Zodiac Produtos Farmaceuticos S.A.1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Efficacy based on cure rate evaluated by clinical and laboratory criteria.
研究概览
简要总结
The purpose of this study is to determine the Efficacy, Tolerability & Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, used for 7 consecutive days in patients with Mixed-Type Vaginosis compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream.
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
- None
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
- •Mixed-type vaginosis
- •Bacterial vaginosis
- •Candidiasis
排除标准
- •Pregnancy
- •Vaginal bleeding
- •History of recurrent vaginosis
研究组 & 干预措施
Clindamycin 100mg and Ketoconazole 400mg
Experimental
干预措施: Clindamycin 100mg and Ketoconazole 400mg (Drug)
Tetracycline 100mg and Amphotericin B 50mg
Active Comparator
干预措施: Tetracycline 100mg and Amphotericin B 50mg (Drug)
结局指标
主要结局
Efficacy based on cure rate evaluated by clinical and laboratory criteria.
时间窗: 7 days
次要结局
- Tolerability based on adverse events reports and patient's information(7 days)
- Safety based on adverse events reports and laboratory criterion(7 days)
研究者
研究点 (1)
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