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
Sponsor:
Collaborator:
Information provided by:
Biosyn
ClinicalTrials.gov Identifier:
NCT00214747
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 ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
Interventional
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00214747
RRU-003
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