Brief Title
Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.
Official Title
Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.
Brief 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.
Study Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
Sensitivity and specificity of the tampon self-test
Secondary Outcome
The womens socio-demographic relations according to accept the tampon self-test
Condition
Uterine Cervical Dysplasia
Intervention
Regular Tampax used in 3 hours
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
100
Start Date
September 2006
Completion Date
March 2008
Primary Completion Date
December 2007
Eligibility Criteria
Inclusion Criteria: 1. Women with cervical dysplasia been referred to conisation or 2. Women invited to cervical screening program Exclusion Criteria: 1. Women not performing the tampon self-test before conisation or 2. Women not performing the tampon self-test af least 1 month after receiving the tampon
Gender
Female
Ages
23 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Hans Svanholm, consultant, ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT00377845
Organization ID
TP06-2351
Study Sponsor
University of Aarhus
Study Sponsor
Hans Svanholm, consultant, Study Director, Randers Hospital, Pathological Institute
Verification Date
March 2008