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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Biosyn National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	Biosyn
ClinicalTrials.gov Identifier:	NCT00214747

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Vehicle gel formulations	Phase I

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Uncontrolled, Single Group Assignment, Pharmacodynamics Study
Official Title:	An Imaging Trial of the Distribution of Topical Gel Formulations in the Human Vagina: Candidate Formulations

Further study details as provided by Biosyn:

Primary Outcome Measures:

MRI evaluation of gel formulation distribution in vagina
Total linear distance in mm covered by gel
Surface area actually covered by gel (mm)

Estimated Enrollment:	6
Study Start Date:	March 2005
Estimated Study Completion Date:	November 2005

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214747

Locations

United States, Pennsylvania
Rreproductive Research Unit, U of Penn Medical Center
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Biosyn

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator:

Kurt Barnhart, MD

University of Pennsylvania

More Information

Study ID Numbers:	RRU-003
Study First Received:	September 13, 2005
Last Updated:	October 24, 2005
ClinicalTrials.gov Identifier:	NCT00214747
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biosyn:

HIV Seronegativity
HIV

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009