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Long-term Active Surveillance Study for Oral Contraceptives (LASS)

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ClinicalTrials.gov Identifier: NCT00676065
Recruitment Status : Completed
First Posted : May 12, 2008
Results First Posted : November 19, 2014
Last Update Posted : November 19, 2014
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany

Study Description
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Brief Summary:
The objective of this study is to characterize and compare the risks of long-term use of oral contraceptives containing drospirenone and of other established oral contraceptives.

Condition or disease
Arterial Thromboembolism Venous Thromboembolism Breast Cancer

Detailed Description:

The LASS Study is a large, multinational, prospective, controlled, non-interventional, long-term cohort study that follows a series of cohorts. The cohorts consist of new users (first-ever users, switchers and restarters) of three different groups of oral contraceptives (OCs): OCs containing drospirenone (DRSP), OCs containing levonorgestrel (LNG) and OCs containing other progestogens. A "non-interference" approach is used to provide standardized, comprehensive, reliable information on these groups of OCs under routine medical conditions.

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.

Study Design
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Study Type : Observational
Actual Enrollment : 58303 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Active Surveillance Study for Oral Contraceptives (LASS)
Study Start Date : February 2001
Actual Primary Completion Date : March 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
1
Women who take oral contraceptives containing drospirenone
2
Women who take oral contraceptives containing levonorgestrel
3
Women who take oral contraceptives containing other progestogens


Outcome Measures
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Primary Outcome Measures :
  1. Arterial Thromboembolism [ Time Frame: Within 10 years ]
    Arterial thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.

  2. Venous Thromboembolism [ Time Frame: Within 10 years ]
    Venous thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.

  3. Breast Cancer [ Time Frame: Within 10 years ]
    Breast cancer associated with the use of hormonal contraceptives either containing both drospirenone (DRSP) and ethinylestradiol (EE), levonorgestrel (LNG) or any other hormonal contraceptive without DRSP.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women attending offices of oral contraceptives prescribing physicians
Criteria

Inclusion Criteria:

  • Women who are prescribed an oral contraceptive and who are new users (first-ever users, switchers or restarters) of the formulation

Exclusion Criteria:

  • Women who do not consent to participate in the study
Contacts and Locations
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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): NCT00676065


Locations
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Germany
Center for Epidemiology and Health Research
Berlin, Germany
Sponsors and Collaborators
Center for Epidemiology and Health Research, Germany
Bayer
Investigators
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Principal Investigator: Juergen Dinger, MD, PhD Center for Epidemiology and Health Research Berlin, Germany
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Juergen Dinger, MD, PhD, Principal Investigator, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier: NCT00676065    
Other Study ID Numbers: ZEG2006_03
First Posted: May 12, 2008    Key Record Dates
Results First Posted: November 19, 2014
Last Update Posted: November 19, 2014
Last Verified: November 2014
Keywords provided by Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany:
Contraception
Thromboembolism
Breast Cancer
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases