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NCT00260767 Clinical Trial

Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Enhanced MRI Techniques to Increase Resolution

HIV Clinical Trial

Official title:
An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Enhanced MRI Techniques to Increase Resolution

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00260767
Other study ID # RRU009
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received November 30, 2005
Last updated November 30, 2005

Study information
Verified date November 2005
Source Biosyn
Contact Kurt Barnhart, MD
Phone 215 662 2974
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This study will assess the distribution of topical gel in the human vagina, using enhanced MRI techniques. The number and size of uncovered areas will be studied, and the upper genital tract will be examined for the presence of topical gel using MRI.

Description:

This study will assess the distribution of topical gel in the human vagina, using enhanced MRI techniques. The number and size of uncovered areas will be studied, and the upper genital tract will be examined for the presence of topical gel using MRI. MRIs will be performed with both a standard pelvic coil and an enhanced resolution endo-rectal coil in order to obtain maximal resolution. MRI images will be acquired before and after simulated coitus.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 6
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- 18 to 45 year old women

- not pregnant

- willingness to use effective method of contraception

- regular menstrual cycle

- normal Pap test result

Exclusion Criteria:

- abnormal pelvic exam

- pregnant or breastfeeding

- claustrophobia or other MRI contraindications

- hypertension, hemolytic anemia,latex allergy

- history of hemorrhoids or irritable bowel syndrome

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• HEC placebo gel

Locations
Country Name City State
United States Reproductive Research Unit, U of Penn Medical Center Philadelphia Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Biosyn National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 1. Number and size of bare spots, before and after simulated coitus.
Primary 2. Number of women with migration of gel into the endocervical canal and/or endometrial canal before and after simulated coitus.
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