Long-term Active Surveillance Study for Oral Contraceptives (LASS)
NCT ID: NCT00676065
Last Updated: 2014-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
58303 participants
OBSERVATIONAL
2001-02-28
2011-12-31
Brief Summary
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Detailed Description
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The main clinical outcomes of interest for the long-term follow-up are arterial and venous thromboembolism as well as breast cancer. Regular, active contacts with the cohort members (=active surveillance) provide all necessary information on health-related events or changes in health status.
The study is based on the existing long-term EURAS cohorts who are still in follow-up. LASS succeeds EURAS and prolongs the follow-up period for another five years. Total follow-up time of members of the long-term cohorts will be between 6 and 10 years. By means of annual contacts almost all relevant clinical outcomes will be captured. This will be accomplished by contacting the relevant physicians and by reviewing relevant source documents in the case of relevant clinical outcomes.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Women who take oral contraceptives containing drospirenone
No interventions assigned to this group
2
Women who take oral contraceptives containing levonorgestrel
No interventions assigned to this group
3
Women who take oral contraceptives containing other progestogens
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
FEMALE
Yes
Sponsors
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Bayer
INDUSTRY
Center for Epidemiology and Health Research, Germany
OTHER
Responsible Party
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Juergen Dinger, MD, PhD
Principal Investigator
Principal Investigators
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Juergen Dinger, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Center for Epidemiology and Health Research Berlin, Germany
Locations
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Center for Epidemiology and Health Research
Berlin, , Germany
Countries
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References
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Dinger J, Mohner S, Heinemann K. Cardiovascular risks associated with the use of drospirenone-containing combined oral contraceptives. Contraception. 2016 May;93(5):378-85. doi: 10.1016/j.contraception.2016.01.012. Epub 2016 Jan 26.
Other Identifiers
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ZEG2006_03
Identifier Type: -
Identifier Source: org_study_id