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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. The completion date has passed and the status has not been verified in more than two years.
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
  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
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:


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   (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
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

ClinicalTrials.gov Identifier: NCT00214812     History of Changes
Other Study ID Numbers: RRU-005
Study First Received: September 13, 2005
Last Updated: October 24, 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

ClinicalTrials.gov processed this record on July 27, 2017