An Imaging Trial of the Distribution of Topical Gel Formulations in the Human Vagina

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

2005-03-31

Study Completion Date

2005-11-30

Brief Summary

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This study is designed to assess the distribution and spread of four different vehicle formulations in the vagina. In-vivo data will be obtained regarding each vehicle formulation at various time points after insertion of the gel into the vagina.

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

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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Vehicle gel formulations

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 to 45 year old women
* non-pregnant
* healthy

Exclusion Criteria

* abnormal finding on pelvic exam
* pregnant or breastfeeding
* allergy to intravaginal products
* history of claustrophobia

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Kurt Barnhart, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Rreproductive Research Unit, U of Penn Medical Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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RRU-003

Identifier Type: -

Identifier Source: org_study_id