- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00214812
An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Assessment of Bare Spots
October 24, 2005 updated by: Biosyn
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.
Study Overview
Study Type
Interventional
Enrollment
6
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kurt Barnhart, MD
- Phone Number: 215 662 2974
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Reproductive Research Unit, U of Penn Medical Center
-
Contact:
- Kurt Barnhart, MD
- Phone Number: 215-662-2974
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Presence or absence of bare spots with and without Gd.
|
Quantification and location of bare spots.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 15, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
October 25, 2005
Last Update Submitted That Met QC Criteria
October 24, 2005
Last Verified
September 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RRU-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on HEC placebo gel
-
BiosynNational Institute of Allergy and Infectious Diseases (NIAID)Unknown
-
CONRADCompleted
-
CONRADCompleted
-
Starpharma Pty LtdNational Institute of Allergy and Infectious Diseases (NIAID); Eunice Kennedy... and other collaboratorsCompletedHealthyUnited States, Puerto Rico
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); National Institute of Mental Health...CompletedHIV InfectionsUnited States, Puerto Rico
-
CONRADWithdrawn
-
Population CouncilCompleted
-
CONRADRTI International; Match Research; UZ-UCSF Collaborative Research ProgrammeCompletedHIV | ContraceptionSouth Africa, Zimbabwe
-
International Partnership for Microbicides, Inc.Withdrawn
-
National Institute of Allergy and Infectious Diseases...Completed