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 because the information has not been verified recently.
Verified September 2005 by Biosyn.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Biosyn
Collaborator:
Information provided by:
Biosyn
ClinicalTrials.gov Identifier:
NCT00214812
First received: September 13, 2005
Last updated: October 24, 2005
Last verified: September 2005
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![](https://webarchive.library.unt.edu/web/20130315212958im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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 Endpoint Classification: Pharmacodynamics Study 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:
![](https://webarchive.library.unt.edu/web/20130315212958im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years to 45 Years |
Genders 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
![](https://webarchive.library.unt.edu/web/20130315212958im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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
Investigators
Principal Investigator: | Kurt Barnhart, MD | University of Pennsylvania |
![](https://webarchive.library.unt.edu/web/20130315212958im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
ClinicalTrials.gov Identifier: | NCT00214812 History of Changes |
Other Study ID Numbers: | RRU-005 |
Study First Received: | September 13, 2005 |
Last Updated: | October 24, 2005 |
Health Authority: | United States: Institutional Review Board |
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 March 14, 2013