An Imaging Trial of the Distribution of Topical Gel Formulations in the Human Vagina
Phase 1
- Conditions
- HIV Infections
- Registration Number
- NCT00214747
- Lead Sponsor
- Biosyn
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 6
Inclusion Criteria
- 18 to 45 year old women
- non-pregnant
- healthy
Exclusion Criteria
- abnormal finding on pelvic exam
- pregnant or breastfeeding
- allergy to intravaginal products
- history of claustrophobia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method MRI evaluation of gel formulation distribution in vagina Total linear distance in mm covered by gel Surface area actually covered by gel (mm)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rreproductive Research Unit, U of Penn Medical Center
🇺🇸Philadelphia, Pennsylvania, United States