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

Early Phase 1

Completed

• Conditions: Uterine Cervical Dysplasia; Uterine Cervical Neoplasms

• Registration Number: NCT00377845
• Lead Sponsor: University of Aarhus

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 available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-18
• Study First Submitted QC: 2006-09-18
• Study First Posted: 2006-09-19
• Primary Completion: 2007-12
• Status Verified: 2008-03
• Study Completion: 2008-03
• Last Update Submitted: 2008-03-26
• Last Update Posted: 2008-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of the tampon self-test

Secondary Outcome Measures

Name	Time	Method
The womens socio-demographic relations according to accept the tampon self-test

Trial Locations

Locations (1)

Region Hospital Randers; 🇩🇰 Randers, Denmark