Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00377845
First received: September 18, 2006
Last updated: March 26, 2008
Last verified: March 2008

September 18, 2006
March 26, 2008
September 2006
December 2007   (final data collection date for primary outcome measure)
Sensitivity and specificity of the tampon self-test
Not Provided
Complete list of historical versions of study NCT00377845 on ClinicalTrials.gov Archive Site
The womens socio-demographic relations according to accept the tampon self-test
Not Provided
Not Provided
Not Provided
 
Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.
Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.

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.

Not Provided
Interventional
Phase 0
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Screening
  • Uterine Cervical Dysplasia
  • Uterine Cervical Neoplasms
Procedure: Regular Tampax used in 3 hours
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2008
December 2007   (final data collection date for primary outcome measure)

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
Female
23 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00377845
TP06-2351
No
Else Toft Würtz, Student
University of Aarhus
Not Provided
Study Director: Hans Svanholm, consultant Randers Hospital, Pathological Institute
University of Aarhus
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP