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

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ClinicalTrials.gov Identifier: NCT00260767
Recruitment Status : Unknown
Verified November 2005 by Biosyn.
Recruitment status was:  Not yet recruiting
First Posted : December 2, 2005
Last Update Posted : December 2, 2005
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
HIV Drug: HEC placebo gel Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
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
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 1. Number and size of bare spots, before and after simulated coitus.
  2. 2. Number of women with migration of gel into the endocervical canal and/or endometrial canal before and after simulated coitus.

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: December 2, 2005    Key Record Dates
Last Update Posted: December 2, 2005
Last Verified: November 2005