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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 because the information has not been verified recently.
Verified November 2005 by Biosyn.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
Biosyn
ClinicalTrials.gov Identifier:
NCT00260767
First received: November 30, 2005
Last updated: NA
Last verified: November 2005
History: No changes posted
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: November 30, 2005
Last Updated: November 30, 2005
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 23, 2016