HealthyNCT00496171
Phase I Study of HAL Formulations Applied to the Cervix in Healthy Volunteers
An observational study of Healthy, run by Photocure at 1 site in Norway.
Trial summary
The purpose of the study is to determine the most effective formulation of HAL for release of hexaminolevulinate to the cervical epithelium at different doses. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- Not given
- Where
- 1 siteNorway
- Study dates
- Start not givento not given
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, pre-menopausal female volunteers
Who cannot join
- Acute or chronic disease which could influence the study results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Hexaminolevulinate (HAL) Dose-Finding Study Applying Different Formulations to the Cervix in Healthy Volunteers
The purpose of the study is to determine the most effective formulation of HAL for release of hexaminolevulinate to the cervical epithelium at different doses.
- Conditions
- Healthy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Observational
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Photocure
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Claes G Tropé, MD PhD, Principal investigator, Riks-Radium University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496171
- Sponsor's protocol ID
- PC CE102/07
- Status last verified
- Jan 2009
- First submitted
- 3 Jul 2007
- Last updated
- 16 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Hexaminolevulinate (HAL) Dose-Finding Study Applying Different Formulations to the Cervix in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00496171
- Acronym / sponsor ID
- PC CE102/07
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Terminated
- Lead sponsor
- PhotocureIndustry (pharma, biotech, devices)
- First posted
- 4 Jul 2007 (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.
The purpose of the study is to determine the most effective formulation of HAL for release of hexaminolevulinate to the cervical epithelium at different doses.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy, pre-menopausal female volunteers
Key exclusion criteria (1 listed)
- Acute or chronic disease which could influence the study results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2009.
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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.
Claes G Tropé, MD PhD principal investigator
Riks-Radium University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Photocure at 1 site in Norway.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 16 Jan 2009. 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 Norway. 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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 16 Jan 2009.