Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Enhanced MRI Techniques to Increase Resolution

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by Biosyn.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
Biosyn
ClinicalTrials.gov Identifier:
NCT00260767
First received: November 30, 2005
Last updated: NA
Last verified: November 2005
History: No changes posted

November 30, 2005
November 30, 2005
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  • 1. Number and size of bare spots, before and after simulated coitus.
  • 2. Number of women with migration of gel into the endocervical canal and/or endometrial canal before and after simulated coitus.
Same as current
No Changes Posted
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Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Enhanced MRI Techniques to Increase Resolution
An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Enhanced MRI Techniques to Increase Resolution

This study will assess the distribution of topical gel in the human vagina, using enhanced MRI techniques. The number and size of uncovered areas will be studied, and the upper genital tract will be examined for the presence of topical gel using MRI.

This study will assess the distribution of topical gel in the human vagina, using enhanced MRI techniques. The number and size of uncovered areas will be studied, and the upper genital tract will be examined for the presence of topical gel using MRI. MRIs will be performed with both a standard pelvic coil and an enhanced resolution endo-rectal coil in order to obtain maximal resolution. MRI images will be acquired before and after simulated coitus.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
Drug: HEC placebo gel
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
6
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Inclusion Criteria:

  • 18 to 45 year old women
  • not pregnant
  • willingness to use effective method of contraception
  • regular menstrual cycle
  • normal Pap test result

Exclusion Criteria:

  • abnormal pelvic exam
  • pregnant or breastfeeding
  • claustrophobia or other MRI contraindications
  • hypertension, hemolytic anemia,latex allergy
  • history of hemorrhoids or irritable bowel syndrome
Female
18 Years to 45 Years
No
Contact: Kurt Barnhart, MD 215 662 2974
United States
 
NCT00260767
RRU009
Not Provided
Not Provided
Biosyn
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Kurt Barnhart, MD University of Pennsylvania Medical Center
Biosyn
November 2005

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