HIVPhase 1NCT00260767
Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Enhanced MRI Techniques to Increase Resolution
A Phase 1 study of HIV, run by Biosyn at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- HIV
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 45 year old women
- not pregnant
- willingness to use effective method of contraception
- regular menstrual cycle
- normal Pap test result
Who cannot join
- abnormal pelvic exam
- pregnant or breastfeeding
- claustrophobia or other MRI contraindications
- hypertension, hemolytic anemia,latex allergy
- history of hemorrhoids or irritable bowel syndrome
Trial locations and contacts
1 site in 1 country.
Kurt Barnhart, MD contact
United States1 site
Reproductive Research Unit, U of Penn Medical Center
Philadelphia, Pennsylvania, 19104
Kurt Barnhart, MD, MSCE
About this study
Official title: An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Enhanced MRI Techniques to Increase Resolution
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.
- Conditions
- HIV
- Being tested
- HEC placebo gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC placebo gelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants
Sponsor and investigators
- Lead sponsor
- Biosyn
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kurt Barnhart, MD, Principal investigator, University of Pennsylvania Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260767
- Sponsor's protocol ID
- RRU009
- Status last verified
- Nov 2005
- First submitted
- 30 Nov 2005
- Last updated
- 2 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Enhanced MRI Techniques to Increase Resolution
- ClinicalTrials.gov ID
- NCT00260767
- Acronym / sponsor ID
- RRU009
- Conditions
- HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants
- Lead sponsor
- BiosynIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- First posted
- 2 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 to 45 year old women
- not pregnant
- willingness to use effective method of contraception
- regular menstrual cycle
- normal Pap test result
Key exclusion criteria (5 listed)
- abnormal pelvic exam
- pregnant or breastfeeding
- claustrophobia or other MRI contraindications
- hypertension, hemolytic anemia,latex allergy
- history of hemorrhoids or irritable bowel syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEC placebo gel | Drug | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt Barnhart, MD contact
Kurt Barnhart, MD principal investigator
University of Pennsylvania Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of HIV, run by Biosyn at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kurt Barnhart, MD (215 662 2974), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Number and size of bare spots, before and after simulated coitus.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2005.