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

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ClinicalTrials.gov Identifier: NCT00214812
Recruitment Status : Unknown
Verified September 2005 by Biosyn.
Recruitment status was:  Recruiting
First Posted : September 22, 2005
Last Update Posted : October 25, 2005
Sponsor:
Collaborator:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: HEC placebo gel Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Assessment of Bare Spots
Study Start Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Rashes
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Presence or absence of bare spots with and without Gd.
  2. Quantification and location of bare spots.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00214812     History of Changes
Other Study ID Numbers: RRU-005
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: October 25, 2005
Last Verified: September 2005

Keywords provided by Biosyn:
HIV Seronegativity
HIV

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