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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:
ClinicalTrials.gov Identifier:
NCT00214812
First Posted: September 22, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
Biosyn
September 13, 2005
September 22, 2005
December 9, 2005
June 2005
Not Provided
  • Presence or absence of bare spots with and without Gd.
  • Quantification and location of bare spots.
Same as current
Complete list of historical versions of study NCT00214812 on ClinicalTrials.gov Archive Site
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An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Assessment of Bare Spots
An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Assessment of Bare Spots
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
HIV Infections
Drug: HEC placebo gel
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
6
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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
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00214812
RRU-005
Not Provided
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Biosyn
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Kurt Barnhart, MD University of Pennsylvania
Biosyn
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP