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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2005 by Biosyn.
Recruitment status was Recruiting

Sponsor:

Collaborator:

National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by:

Biosyn

ClinicalTrials.gov Identifier:

NCT00214812

First received: September 13, 2005

Last updated: October 24, 2005

Last verified: September 2005

History of Changes

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 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
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: HIV/AIDS Rashes

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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

Keywords provided by Biosyn:


HIV Seronegativity HIV

ClinicalTrials.gov processed this record on February 27, 2015

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