Trial record 19 of 110 for:
Open Studies | "Exanthema"
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
Information provided by:
First received: September 13, 2005
Last updated: October 24, 2005
Last verified: September 2005
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.
Drug: HEC placebo gel
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
||An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Assessment of Bare Spots
Primary Outcome Measures:
- Presence or absence of bare spots with and without Gd.
- Quantification and location of bare spots.
| Estimated Enrollment:
| Study Start Date:
|Ages Eligible for Study:
||18 Years to 45 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 18 -45 year old women
- normal Pap smear
- not pregnant
- abnormal pelvic exam
- history of claustrophobia
- allergy to product formulation
- pregnant or breastfeeding
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00214812
|Contact: Kurt Barnhart, MD
||215 662 2974
|Reproductive Research Unit, U of Penn Medical Center
|Philadelphia, Pennsylvania, United States, 19104 |
|Contact: Kurt Barnhart, MD 215-662-2974 |
||Kurt Barnhart, MD
||University of Pennsylvania
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 13, 2005
||October 24, 2005
||United States: Institutional Review Board
Keywords provided by Biosyn:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014
Acquired Immunodeficiency Syndrome
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases