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

November 30, 2005 updated by: Biosyn

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kurt Barnhart, MD
  • Phone Number: 215 662 2974

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Reproductive Research Unit, U of Penn Medical Center
        • Principal Investigator:
          • Kurt Barnhart, MD, MSCE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosyn

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Kurt Barnhart, MD, University of Pennsylvania Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 30, 2005

First Submitted That Met QC Criteria

November 30, 2005

First Posted (Estimate)

December 2, 2005

Study Record Updates

Last Update Posted (Estimate)

December 2, 2005

Last Update Submitted That Met QC Criteria

November 30, 2005

Last Verified

November 1, 2005

More Information

Terms related to this study

Other Study ID Numbers

  • RRU009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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