An Imaging Trial of the Distribution of Topical Gel Formulations in the Human Vagina
This trial is active, not recruiting.
|Treatment||vehicle gel formulations|
|Collaborator||National Institute of Allergy and Infectious Diseases (NIAID)|
|Start date||March 2005|
|End date||November 2005|
|Trial size||6 participants|
|Trial identifier||NCT00214747, RRU-003|
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.
|Endpoint classification||pharmacodynamics study|
|Intervention model||single group assignment|
MRI evaluation of gel formulation distribution in vagina
Total linear distance in mm covered by gel
Surface area actually covered by gel (mm)
Female participants from 18 years up to 45 years old.
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
|Official title||An Imaging Trial of the Distribution of Topical Gel Formulations in the Human Vagina: Candidate Formulations|
|Principal investigator||Kurt Barnhart, MD|
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