Imaging Trial of the Distribution of Topical Gel in the H... | NCT00260767

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

NCT00260767

Sponsor

Biosyn

Status

Unknown status

Last Update Posted

Dec 2, 2005Estimated

Enrollment

Phase

Phase 1

Conditions

Interventions

HEC placebo gel

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 30, 2005

First Submission Date that Met QC Criteria

Nov 30, 2005

First Posted Date

Dec 2, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2005

Last Update Posted Date

Dec 2, 2005Estimated

Name	Class
National Institute of Allergy and Infectious Diseases (NIAID)	NIH

Description Module

Brief Summary

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
HEC placebo gel	Drug

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kurt Barnhart, MD	Contact	215 662 2974

Overall Officials

Name	Affiliation	Role
Kurt Barnhart, MD	University of Pennsylvania Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Reproductive Research Unit, U of Penn Medical Center		Philadelphia	Pennsylvania	19104	United States