Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Enhanced MRI Techniques to Increase Resolution
- Conditions
- HIV
- Registration Number
- NCT00260767
- Lead Sponsor
- Biosyn
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 6
- 18 to 45 year old women
- not pregnant
- willingness to use effective method of contraception
- regular menstrual cycle
- normal Pap test result
- abnormal pelvic exam
- pregnant or breastfeeding
- claustrophobia or other MRI contraindications
- hypertension, hemolytic anemia,latex allergy
- history of hemorrhoids or irritable bowel syndrome
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Reproductive Research Unit, U of Penn Medical Center
🇺🇸Philadelphia, Pennsylvania, United States