Overview

This trial is active, not recruiting.

Condition hiv infections
Treatment vehicle gel formulations
Phase phase 1
Sponsor Biosyn
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacodynamics study
Intervention model single group assignment
Masking double-blind
Primary purpose diagnostic

Primary Outcomes

Measure
MRI evaluation of gel formulation distribution in vagina
time frame:
Total linear distance in mm covered by gel
time frame:
Surface area actually covered by gel (mm)
time frame:

Eligibility Criteria

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

Additional Information

Official title An Imaging Trial of the Distribution of Topical Gel Formulations in the Human Vagina: Candidate Formulations
Principal investigator Kurt Barnhart, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2005.
Information provided to ClinicalTrials.gov by Biosyn.