An Imaging Trial of the Distribution of Topical Gel in th... | NCT00214812

Studies
An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Assessment of Bare Spots

NCT00214812

Sponsor

Biosyn

Status

Unknown status

Last Update Posted

Oct 25, 2005Estimated

Enrollment

Phase

Phase 1

Conditions

HIV Infections

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

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 15, 2005

First Posted Date

Sep 22, 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

Oct 24, 2005

Last Update Posted Date

Oct 25, 2005Estimated

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

Description Module

Brief Summary

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.

Detailed Description

Not provided

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
Presence or absence of bare spots with and without Gd.
Quantification and location of bare spots.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

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	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided