NCT00260767

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 hiv

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2005

Completed
Last Updated

December 2, 2005

Status Verified

November 1, 2005

First QC Date

November 30, 2005

Last Update Submit

November 30, 2005

Conditions

HIV

Outcome Measures

Primary Outcomes (2)

  • 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.

Interventions

HEC placebo gelDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • to 45 year old women
  • not pregnant
  • willingness to use effective method of contraception
  • regular menstrual cycle
  • normal Pap test result

You may not qualify if:

  • abnormal pelvic exam
  • pregnant or breastfeeding
  • claustrophobia or other MRI contraindications
  • hypertension, hemolytic anemia,latex allergy
  • history of hemorrhoids or irritable bowel syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Research Unit, U of Penn Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

  • Kurt Barnhart, MD

    University of Pennsylvania Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kurt Barnhart, MD

CONTACT

215 662 2974

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 30, 2005

First Posted

December 2, 2005

Last Updated

December 2, 2005

Record last verified: 2005-11

Locations

US(1)