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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00377845
Recruitment Status : Completed
First Posted : September 19, 2006
Last Update Posted : March 27, 2008
Sponsor:
Information provided by:
University of Aarhus

Tracking Information
First Submitted Date  ICMJE September 18, 2006
First Posted Date  ICMJE September 19, 2006
Last Update Posted Date March 27, 2008
Study Start Date  ICMJE September 2006
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2007)
Sensitivity and specificity of the tampon self-test
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2007)
The womens socio-demographic relations according to accept the tampon self-test
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.
Official Title  ICMJE 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Screening
Condition  ICMJE
  • Uterine Cervical Dysplasia
  • Uterine Cervical Neoplasms
Intervention  ICMJE Procedure: Regular Tampax used in 3 hours
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 18, 2006)
100
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 23 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00377845
Other Study ID Numbers  ICMJE TP06-2351
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Else Toft Würtz, Student
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hans Svanholm, consultant Randers Hospital, Pathological Institute
PRS Account University of Aarhus
Verification Date March 2008

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