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

Primary Purpose

HIV Infections

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

HEC placebo gel

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV Seronegativity, HIV

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Reproductive Research Unit, U of Penn Medical CenterRecruiting

Outcomes

Primary Outcome Measures

Presence or absence of bare spots with and without Gd.

Quantification and location of bare spots.

Secondary Outcome Measures

Full Information

NCT ID

NCT00214812

First Posted

September 13, 2005

Last Updated

October 24, 2005

Sponsor

Biosyn

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

1. Study Identification

Unique Protocol Identification Number

NCT00214812

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Unknown status

Study Start Date

June 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Biosyn

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

HIV Seronegativity, HIV

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

6 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

HEC placebo gel

Primary Outcome Measure Information:

Title

Presence or absence of bare spots with and without Gd.

Title

Quantification and location of bare spots.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kurt Barnhart, MD

Phone

215 662 2974

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kurt Barnhart, MD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

Reproductive Research Unit, U of Penn Medical Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kurt Barnhart, MD

Phone

215-662-2974

12. IPD Sharing Statement

Learn more about this trial

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

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