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

This study is currently recruiting participants.

Verified by Biosyn, September 2005

First Received: September 13, 2005 Last Updated: October 24, 2005 History of Changes

Sponsor:	Biosyn
Collaborator:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	Biosyn
ClinicalTrials.gov Identifier:	NCT00214812

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: HEC placebo gel	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Uncontrolled, Crossover Assignment, Pharmacodynamics Study
Official Title:	An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Assessment of Bare Spots

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by Biosyn:

Primary Outcome Measures:

Presence or absence of bare spots with and without Gd.
Quantification and location of bare spots.

Estimated Enrollment:	6
Study Start Date:	June 2005

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214812

Contacts

Contact: Kurt Barnhart, MD

215 662 2974

Locations

United States, Pennsylvania
Reproductive Research Unit, U of Penn Medical Center	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kurt Barnhart, MD 215-662-2974

Sponsors and Collaborators

Biosyn

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator:

Kurt Barnhart, MD

University of Pennsylvania

More Information

No publications provided

Study ID Numbers:	RRU-005
Study First Received:	September 13, 2005
Last Updated:	October 24, 2005
ClinicalTrials.gov Identifier:	NCT00214812 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Biosyn:

HIV Seronegativity
HIV

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on February 08, 2010