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| Tracking Information | |||||
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| First Received Date ICMJE | September 18, 2006 | ||||
| Last Updated Date | March 26, 2008 | ||||
| Start Date ICMJE | September 2006 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Sensitivity and specificity of the tampon self-test | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00377845 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
The womens socio-demographic relations according to accept the tampon self-test | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear. | ||||
| Official Title ICMJE | Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear. | ||||
| 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. |
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| Detailed Description | |||||
| Study Phase | Phase 0 | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Screening, Non-Randomized, Single Blind, Historical Control, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Procedure: Regular Tampax used in 3 hours | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | March 2008 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 23 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00377845 | ||||
| Responsible Party | Else Toft Würtz, Student | ||||
| Study ID Numbers ICMJE | TP06-2351 | ||||
| Study Sponsor ICMJE | University of Aarhus | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of Aarhus | ||||
| Verification Date | March 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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