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

Early Phase 1CompletedNCT00377845

University of Aarhus100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Enrollment

100

Conditions

Uterine Cervical Dysplasia Uterine Cervical Neoplasms

Interventions

Regular Tampax used in 3 hoursPROCEDURE

Eligibility

Sex: FEMALEMin age: 23 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Region Hospital Randers

Randers, Denmark

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

Data from ClinicalTrials.gov

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