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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00377845

Enrollment

100

Registered

2006-09-19

Start date

2006-09-30

Completion date

2008-03-31

Last updated

2008-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Cervical Dysplasia, Uterine Cervical Neoplasms

Keywords

self test, PAP smear, tampon test, cervical dysplasia

Brief 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.

Interventions

PROCEDURERegular Tampax used in 3 hours

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

SINGLE

Eligibility

Sex/Gender

FEMALE

Age

23 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Sensitivity and specificity of the tampon self-test	—

Secondary

Measure	Time frame
The womens socio-demographic relations according to accept the tampon self-test	—

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026