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

Uterine Cervical Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00377845
• Other study ID #: TP06-2351
• Status: Completed
• Phase: Phase 0
• First received: September 18, 2006
• Last updated: March 26, 2008
• Start date: September 2006
• Est. completion date: March 2008

Study information

• Verified date: March 2008
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 23 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Screening

Related Conditions & MeSH terms

• Cervical Intraepithelial Neoplasia
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Regular Tampax used in 3 hours

Locations

Country	Name	City	State
Denmark	Region Hospital Randers	Randers

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of the tampon self-test
Secondary	The womens socio-demographic relations according to accept the tampon self-test