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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
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on March 14, 2013