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
Information provided by:
First received: September 13, 2005
Last updated: October 24, 2005
Last verified: September 2005
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.
Drug: Vehicle gel formulations
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Primary Purpose: Diagnostic
||An Imaging Trial of the Distribution of Topical Gel Formulations in the Human Vagina: Candidate Formulations
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:
| Study Start Date:
| Estimated Study Completion Date:
|Ages Eligible for Study:
||18 Years to 45 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 18 to 45 year old women
- abnormal finding on pelvic exam
- pregnant or breastfeeding
- allergy to intravaginal products
- history of claustrophobia
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: NCT00214747
|Rreproductive Research Unit, U of Penn Medical Center
|Philadelphia, Pennsylvania, United States, 19104 |
||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: Food and Drug Administration
Keywords provided by Biosyn:
ClinicalTrials.gov processed this record on July 01, 2015