An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Assessment of Bare Spots
Phase 1
- Conditions
- HIV Infections
- Registration Number
- NCT00214812
- Lead Sponsor
- Biosyn
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 6
Inclusion Criteria
- 18 -45 year old women
- normal Pap smear
- not pregnant
Exclusion Criteria
- abnormal pelvic exam
- history of claustrophobia
- allergy to product formulation
- pregnant or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Presence or absence of bare spots with and without Gd. Quantification and location of bare spots.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Reproductive Research Unit, U of Penn Medical Center
🇺🇸Philadelphia, Pennsylvania, United States