NCT00214812Unknown1 期
An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Assessment of Bare Spots
Biosyn2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2005年6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
- Presence or absence of bare spots with and without Gd.
研究概览
简要总结
This study will assess the distribution of a microbicidal gel in the vagina and confirm the presence of bare spots. MRIs will be done with and without the addition of the MRI contrast Gadolinium to the microbicide in order to determine whether the bare spots are an artifact of the MRI technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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 -45 year old women
- •normal Pap smear
- •not pregnant
排除标准
- •abnormal pelvic exam
- •history of claustrophobia
- •allergy to product formulation
- •pregnant or breastfeeding
结局指标
主要结局
Presence or absence of bare spots with and without Gd.
Quantification and location of bare spots.
次要结局
未报告次要终点
研究者
研究点 (2)
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