CClinicalTrials.gg
Status unknownNCT00260767Updated Dec 2, 2005

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

A Phase 1 interventional study of HEC placebo gel in HIV, sponsored by Biosyn. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2005-12-02.

Sponsored by Biosyn · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2005), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • HIV
03

In context

Lead sponsor

Biosyn is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants

Interventions

  • DrugHEC placebo gel
06

What researchers measure

Primary outcomes

  1. 1. Number and size of bare spots, before and after simulated coitus.

  2. 2. Number of women with migration of gel into the endocervical canal and/or endometrial canal before and after simulated coitus.

07

Study locations

1 site
  • Reproductive Research Unit, U of Penn Medical Center
    Philadelphia, Pennsylvania 19104, United States
    • Kurt Barnhart, MD, MSCE · Principal investigator
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00260767
Lead sponsor
Biosyn
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
First posted
Dec 2, 2005
Last update
Dec 2, 2005

Study contacts

Kurt Barnhart, MD
Contact
215 662 2974
Kurt Barnhart, MD
principal investigator · University of Pennsylvania Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2005. You cannot join it, but the record below documents what was studied.

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