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

University of Aarhus

Status and phase: Completed; Early Phase 1

Conditions: Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

Treatments: Procedure: Regular Tampax used in 3 hours

Study type: Interventional

Funder types: Other

Identifiers

NCT00377845

TP06-2351

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 23+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind