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

NCT ID: NCT00260767

Last Updated: 2005-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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HEC placebo gel

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Biosyn

INDUSTRY

Sponsor Role lead

Principal Investigators

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Kurt Barnhart, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania Medical Center

Locations

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Reproductive Research Unit, U of Penn Medical Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Central Contacts

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Kurt Barnhart, MD

Role: CONTACT

Phone: 215 662 2974

Other Identifiers

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RRU009

Identifier Type: -

Identifier Source: org_study_id