Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Biosyn.
Recruitment status was  Active, not recruiting
Information provided by:
Biosyn Identifier:
First received: September 13, 2005
Last updated: October 24, 2005
Last verified: September 2005

September 13, 2005
October 24, 2005
March 2005
Not Provided
  • MRI evaluation of gel formulation distribution in vagina
  • Total linear distance in mm covered by gel
  • Surface area actually covered by gel (mm)
Same as current
Complete list of historical versions of study NCT00214747 on Archive Site
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An Imaging Trial of the Distribution of Topical Gel Formulations in the Human Vagina
An Imaging Trial of the Distribution of Topical Gel Formulations in the Human Vagina: Candidate Formulations

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.

Not Provided
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
HIV Infections
Drug: Vehicle gel formulations
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Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
November 2005
Not Provided

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
18 Years to 45 Years
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Kurt Barnhart, MD University of Pennsylvania
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP