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An Imaging Trial of the Distribution of Topical Gel Formulations in the Human Vagina

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:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00214747
First Posted: September 22, 2005
Last Update Posted: October 25, 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
  Purpose
This study is designed to assess the distribution and spread of four different vehicle formulations in the vagina. In-vivo data will be obtained regarding each vehicle formulation at various time points after insertion of the gel into the vagina.

Condition Intervention Phase
HIV Infections Drug: Vehicle gel formulations Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: An Imaging Trial of the Distribution of Topical Gel Formulations in the Human Vagina: Candidate Formulations

Resource links provided by NLM:


Further study details as provided by Biosyn:

Primary Outcome Measures:
  • MRI evaluation of gel formulation distribution in vagina
  • Total linear distance in mm covered by gel
  • Surface area actually covered by gel (mm)

Estimated Enrollment: 6
Study Start Date: March 2005
Estimated Study Completion Date: November 2005
  Eligibility

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 to 45 year old women
  • non-pregnant
  • healthy

Exclusion Criteria:

  • abnormal finding on pelvic exam
  • pregnant or breastfeeding
  • allergy to intravaginal products
  • history of claustrophobia
  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): NCT00214747


Locations
United States, Pennsylvania
Rreproductive Research Unit, U of Penn Medical Center
Philadelphia, Pennsylvania, United States, 19104
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: NCT00214747     History of Changes
Other Study ID Numbers: RRU-003
First Submitted: September 13, 2005
First Posted: September 22, 2005
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