We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00377845
First Posted: September 19, 2006
Last Update Posted: March 27, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Aarhus
  Purpose

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.


Condition Intervention Phase
Uterine Cervical Dysplasia Uterine Cervical Neoplasms Procedure: Regular Tampax used in 3 hours Early Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Screening
Official Title: Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Sensitivity and specificity of the tampon self-test

Secondary Outcome Measures:
  • The womens socio-demographic relations according to accept the tampon self-test

Estimated Enrollment: 100
Study Start Date: September 2006
Study Completion Date: March 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   23 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377845


Locations
Denmark
Region Hospital Randers
Randers, Denmark, 8900
Sponsors and Collaborators
University of Aarhus
Investigators
Study Director: Hans Svanholm, consultant Randers Hospital, Pathological Institute
  More Information

Responsible Party: Else Toft Würtz, Student
ClinicalTrials.gov Identifier: NCT00377845     History of Changes
Other Study ID Numbers: TP06-2351
First Submitted: September 18, 2006
First Posted: September 19, 2006
Last Update Posted: March 27, 2008
Last Verified: March 2008

Keywords provided by University of Aarhus:
self test
PAP smear
tampon test
cervical dysplasia

Additional relevant MeSH terms:
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Uterine Cervical Neoplasms
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site