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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV | Drug: HEC placebo gel | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
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 |
- 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.

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

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
Contact: Kurt Barnhart, MD | 215 662 2974 |
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 |
Principal Investigator: | Kurt Barnhart, MD | University of Pennsylvania Medical Center |
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 |