An Imaging Trial of the Distribution of Topical Gel Formulations in the Human Vagina

• Status: Unknown status
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• 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 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