HIV
Conditions
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.
Interventions
DRUGHEC placebo gel
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Biosyn
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 45 year old women * not pregnant * willingness to use effective method of contraception * regular menstrual cycle * normal Pap test result
Exclusion criteria
* abnormal pelvic exam * pregnant or breastfeeding * claustrophobia or other MRI contraindications * hypertension, hemolytic anemia,latex allergy * history of hemorrhoids or irritable bowel syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Contacts
Primary ContactKurt Barnhart, MD
Outcome results
None listed