Back to resultsAn Imaging Trial of the Distribution of Topical Gel Formulations in the Human Vagina
Primary Purpose
HIV Infections
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vehicle gel formulations
Sponsored by
About this trial
This is an interventional diagnostic trial for HIV Infections focused on measuring HIV Seronegativity, HIV
Eligibility 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
Sites / Locations
- Rreproductive Research Unit, U of Penn Medical Center
Outcomes
Primary Outcome Measures
MRI evaluation of gel formulation distribution in vagina
Total linear distance in mm covered by gel
Surface area actually covered by gel (mm)
Secondary Outcome Measures
Full Information
NCT ID
NCT00214747
First Posted
September 13, 2005
Last Updated
October 24, 2005
Sponsor
Biosyn
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00214747
Brief Title
An Imaging Trial of the Distribution of Topical Gel Formulations in the Human Vagina
Official Title
An Imaging Trial of the Distribution of Topical Gel Formulations in the Human Vagina: Candidate Formulations
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Biosyn
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV Seronegativity, HIV
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
6 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Vehicle gel formulations
Primary Outcome Measure Information:
Title
MRI evaluation of gel formulation distribution in vagina
Title
Total linear distance in mm covered by gel
Title
Surface area actually covered by gel (mm)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt Barnhart, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rreproductive Research Unit, U of Penn Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Imaging Trial of the Distribution of Topical Gel Formulations in the Human Vagina
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