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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Uterine Cervical Dysplasia
Uterine Cervical Neoplasms
 Procedure: Regular Tampax used in 3 hours
 Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Screening
Official Title: Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Sensitivity and specificity of the tampon self-test

Secondary Outcome Measures:
  • The womens socio-demographic relations according to accept the tampon self-test

Estimated Enrollment: 100
Study Start Date: September 2006
Study Completion Date: March 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   23 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377845

Locations
Denmark
Region Hospital Randers
Randers, Denmark, 8900
Sponsors and Collaborators
University of Aarhus
Investigators
Study Director: Hans Svanholm, consultant Randers Hospital, Pathological Institute
  More Information

No publications provided

Responsible Party: Else Toft Würtz, Student
ClinicalTrials.gov Identifier: NCT00377845     History of Changes
Other Study ID Numbers: TP06-2351
Study First Received: September 18, 2006
Last Updated: March 26, 2008
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by University of Aarhus:
self test
PAP smear
tampon test
cervical dysplasia

Additional relevant MeSH terms:
Neoplasms
Uterine Cervical Neoplasms
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Precancerous Conditions
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 19, 2013