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Clinical Trials/NCT00377845
NCT00377845
Completed
Early Phase 1

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

University of Aarhus1 site in 1 country100 target enrollmentSeptember 2006

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Uterine Cervical Dysplasia
Sponsor
University of Aarhus
Enrollment
100
Locations
1
Primary Endpoint
Sensitivity and specificity of the tampon self-test
Status
Completed
Last Updated
18 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2006
End Date
March 2008
Last Updated
18 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • Women with cervical dysplasia been referred to conisation or
  • Women invited to cervical screening program

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Sensitivity and specificity of the tampon self-test

Secondary Outcomes

  • The womens socio-demographic relations according to accept the tampon self-test

Study Sites (1)

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