Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Enhanced MRI Techniques to Increase Resolution

biosyn Arzneimittel

Status and phase: Unknown; Phase 1

Conditions: HIV

Treatments: Drug: HEC placebo gel

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00260767

RRU009

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)