NCT00616330已完成3 期
Vaginal Infection Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,443
- 试验地点
- 130
- 主要终点
- Clinical symptom resolution.
研究概览
简要总结
This study will evaluate the efficacy and safety of a vaginal product compared with that of other vaginal products in the treatment of vaginal infections.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must have a clinical diagnosis of vaginal infection.
- •Patients must be post-menopausal, surgically sterilized or using an acceptable form of birth control.
排除标准
- •Patients must not have any other infections
- •May not be pregnant or nursing
- •May not be receiving any other antimicrobial therapies or any medications that would interfere with the outcome of the study.
研究组 & 干预措施
1
Experimental
clindamycin phosphate/butoconazole nitrate
干预措施: clindamycin phosphate/butoconazole nitrate (Drug)
2
Active Comparator
clindamycin phosphate
干预措施: clindamycin phosphate (Drug)
3
Active Comparator
butoconazole nitrate
干预措施: butoconazole nitrate (Drug)
结局指标
主要结局
Clinical symptom resolution.
时间窗: baseline, 7 to 10 days and 21 to 30 days
次要结局
- Yeast Culture for Candida(baseline, 7 to 10 days and 21 to 30 days)
- Gram stain Nugent score(baseline, 7 to 10 days and 21 to 30 days)
- Saline wet mount for clue cells(baseline, 7 to 10 days and 21 to 30 days)
研究者
研究点 (130)
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