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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 because the information has not been verified recently.
Verified September 2005 by Biosyn.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
Biosyn
ClinicalTrials.gov Identifier:
NCT00214747
First received: September 13, 2005
Last updated: October 24, 2005
Last verified: September 2005
History of Changes
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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:

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

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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00214747     History of Changes
Other Study ID Numbers: RRU-003
Study First Received: September 13, 2005
Last Updated: October 24, 2005
Health Authority: United States: Food and Drug Administration

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 May 22, 2013