An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Assessment of Bare Spots

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Biosyn
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)

Criteria

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