NCT00214747Unknown1 期
An Imaging Trial of the Distribution of Topical Gel Formulations in the Human Vagina: Candidate Formulations
Biosyn2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2005年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- MRI evaluation of gel formulation distribution in vagina
研究概览
简要总结
This study is designed to assess the distribution and spread of four different vehicle formulations in the vagina. In-vivo data will be obtained regarding each vehicle formulation at various time points after insertion of the gel into the vagina.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 to 45 year old women
- •non-pregnant
排除标准
- •abnormal finding on pelvic exam
- •pregnant or breastfeeding
- •allergy to intravaginal products
- •history of claustrophobia
结局指标
主要结局
MRI evaluation of gel formulation distribution in vagina
Total linear distance in mm covered by gel
Surface area actually covered by gel (mm)
次要结局
未报告次要终点
研究者
研究点 (2)
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