Uterine Cervical DysplasiaEarly Phase 1NCT00377845
Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.
A Early Phase 1 study testing Regular Tampax used in 3 hours in people with Uterine Cervical Dysplasia and Uterine Cervical Neoplasms, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to compare suitability, specificity and sensitivity of the routine smear and the tampon self-test women perform at home. Study hypothesis: The tampon self-test correspond to the routine cervical smear. Read more about this study
- Who is it for?
- Ages 23 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
- What is being tested?
- Regular Tampax used in 3 hours
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2006to Mar 2008
- Phase
- Early 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 23 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with cervical dysplasia been referred to conisation or
- Women invited to cervical screening program
Who cannot join
- Women not performing the tampon self-test before conisation or
- Women not performing the tampon self-test af least 1 month after receiving the tampon
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare suitability, specificity and sensitivity of the routine smear and the tampon self-test women perform at home.
Study hypothesis: The tampon self-test correspond to the routine cervical smear.
- Being tested
- Regular Tampax used in 3 hours
- Keywords
- self test, PAP smear, tampon test, cervical dysplasia
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular Tampax used in 3 hoursProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the tampon self-test
Secondary outcomes (1)
The womens socio-demographic relations according to accept the tampon self-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical DysplasiaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Hans Svanholm, consultant, Study director, Randers Hospital, Pathological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377845
- Sponsor's protocol ID
- TP06-2351
- Status last verified
- Mar 2008
- First submitted
- 18 Sep 2006
- Last updated
- 27 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.
- ClinicalTrials.gov ID
- NCT00377845
- Acronym / sponsor ID
- TP06-2351
- Keywords
- self test, PAP smear, tampon test, cervical dysplasia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 19 Sep 2006 (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 this study is to compare suitability, specificity and sensitivity of the routine smear and the tampon self-test women perform at home.
Study hypothesis: The tampon self-test correspond to the routine cervical smear.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 23 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women with cervical dysplasia been referred to conisation or
- Women invited to cervical screening program
Key exclusion criteria (2 listed)
- Women not performing the tampon self-test before conisation or
- Women not performing the tampon self-test af least 1 month after receiving the tampon
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 |
|---|---|---|
| Regular Tampax used in 3 hours | Procedure or surgery | – |
Primary outcome
Sensitivity and specificity of the tampon self-test
1 secondary outcome
The womens socio-demographic relations according to accept the tampon self-test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2008.
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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.
Hans Svanholm, consultant study director
Randers Hospital, Pathological Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Regular Tampax used in 3 hours in people with Uterine Cervical Dysplasia and Uterine Cervical Neoplasms, run by University of Aarhus at 1 site in Denmark.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 27 Mar 2008. 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 Denmark. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Sensitivity and specificity of the tampon self-test. 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 27 Mar 2008.