Not Signed In -
Acidulated Phosphate Fluoride Rinse or Gel |
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Clinical Trial: Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Enhanced MRI Techniques to Increase Resolution
This study is not yet open for patient recruitment.
Verified by Biosyn November 2005
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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 I |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
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 Outcomes: 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.
Expected Total Enrollment: 6
Expected Total Enrollment: 6
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 - 45 Years, Genders Eligible for Study: Female
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:
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00260767
Kurt Barnhart, MD 215 662 2974
Pennsylvania
Reproductive Research Unit, U of Penn Medical Center, Philadelphia, Pennsylvania, 19104, United States
Kurt Barnhart, MD, MSCE, Principal Investigator
Study chairs or principal investigators
Kurt Barnhart, MD, Principal Investigator, University of Pennsylvania Medical Center
More Information
Study ID Numbers: RRU009
Last Updated: December 8, 2005
Record first received: November 30, 2005
ClinicalTrials.gov Identifier: NCT00260767
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-10
Last Updated: December 8, 2005
Record first received: November 30, 2005
ClinicalTrials.gov Identifier: NCT00260767
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-10
Resources
- Acidulated Phosphate Fluoride Rinse or Gel (Drug Digest)
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