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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-03-31

Brief Summary

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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

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Conditions

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Uterine Cervical Dysplasia Uterine Cervical Neoplasms

Keywords

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self test PAP smear tampon test cervical dysplasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Interventions

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Regular Tampax used in 3 hours

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

23 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Student

Principal Investigators

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Hans Svanholm, consultant

Role: STUDY_DIRECTOR

Randers Hospital, Pathological Institute

Locations

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Region Hospital Randers

Randers, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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TP06-2351

Identifier Type: -

Identifier Source: org_study_id