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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Biosyn.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00214747
First Posted: September 22, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
Biosyn
September 13, 2005
September 22, 2005
December 9, 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 ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Diagnostic
HIV Infections
Drug: Vehicle gel formulations
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
6
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
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00214747
RRU-003
Not Provided
Not Provided
Not Provided
Not Provided
Biosyn
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Kurt Barnhart, MD University of Pennsylvania
Biosyn
September 2005

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