An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Enhanced MRI Techniques to Increase Resolution
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
- 1. Number and size of bare spots, before and after simulated coitus.
研究概览
简要总结
This study will assess the distribution of topical gel in the human vagina, using enhanced MRI techniques. The number and size of uncovered areas will be studied, and the upper genital tract will be examined for the presence of topical gel using MRI.
详细描述
This study will assess the distribution of topical gel in the human vagina, using enhanced MRI techniques. The number and size of uncovered areas will be studied, and the upper genital tract will be examined for the presence of topical gel using MRI. MRIs will be performed with both a standard pelvic coil and an enhanced resolution endo-rectal coil in order to obtain maximal resolution. MRI images will be acquired before and after simulated coitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 to 45 year old women
- •not pregnant
- •willingness to use effective method of contraception
- •regular menstrual cycle
- •normal Pap test result
排除标准
- •abnormal pelvic exam
- •pregnant or breastfeeding
- •claustrophobia or other MRI contraindications
- •hypertension, hemolytic anemia,latex allergy
- •history of hemorrhoids or irritable bowel syndrome
结局指标
主要结局
1. Number and size of bare spots, before and after simulated coitus.
2. Number of women with migration of gel into the endocervical canal and/or endometrial canal before and after simulated coitus.
次要结局
未报告次要终点