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An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Assessment of Bare Spots

NCT ID: NCT00214812

Last Updated: 2005-10-25

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

Study Start Date

2005-06-30

Brief Summary

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This study will assess the distribution of a microbicidal gel in the vagina and confirm the presence of bare spots. MRIs will be done with and without the addition of the MRI contrast Gadolinium to the microbicide in order to determine whether the bare spots are an artifact of the MRI technique.

Detailed Description

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Conditions

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HIV Infections

Keywords

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HIV Seronegativity HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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HEC placebo gel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 -45 year old women
* normal Pap smear
* not pregnant

Exclusion Criteria

* abnormal pelvic exam
* history of claustrophobia
* allergy to product formulation
* pregnant or breastfeeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

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

Locations

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Reproductive Research Unit, U of Penn Medical Center

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kurt Barnhart, MD

Role: CONTACT

Phone: 215 662 2974

Facility Contacts

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Kurt Barnhart, MD

Role: primary

Other Identifiers

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RRU-005

Identifier Type: -

Identifier Source: org_study_id