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

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.

Completed

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Key information

Conditions

Uterine Cervical Dysplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Precancerous Conditions Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

23 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Region Hospital Randers

Randers, 8900, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women with cervical dysplasia been referred to conisation or
Women invited to cervical screening program

Exclusion criteria

Women not performing the tampon self-test before conisation or
Women not performing the tampon self-test af least 1 month after receiving the tampon

Treatment and study plan

Regular Tampax used in 3 hours

Procedure

Primary outcomes

Sensitivity and specificity of the tampon self-test

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2008
First posted: Sep 19, 2006
Registry last updated: Mar 27, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed