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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. The completion date has passed and the status has not been verified in more than two years.
Verified November 2005 by Biosyn.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00260767
First Posted: December 2, 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
  Purpose
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.

Condition Intervention Phase
HIV Drug: HEC placebo gel Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Enhanced MRI Techniques to Increase Resolution

Further study details as provided by Biosyn:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 6
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00260767


Contacts
Contact: Kurt Barnhart, MD 215 662 2974

Locations
United States, Pennsylvania
Reproductive Research Unit, U of Penn Medical Center Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Kurt Barnhart, MD, MSCE         
Sponsors and Collaborators
Biosyn
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Kurt Barnhart, MD University of Pennsylvania Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00260767     History of Changes
Other Study ID Numbers: RRU009
First Submitted: November 30, 2005
First Posted: December 2, 2005
Last Update Posted: December 9, 2005
Last Verified: November 2005


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