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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier:
NCT00676065
First received: May 8, 2008
Last updated: November 13, 2014
Last verified: November 2014

May 8, 2008
November 13, 2014
February 2001
March 2011   (final data collection date for primary outcome measure)
  • Arterial Thromboembolism [ Time Frame: Within 10 years ] [ Designated as safety issue: Yes ]
    Arterial thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.
  • Venous Thromboembolism [ Time Frame: Within 10 years ] [ Designated as safety issue: Yes ]
    Venous thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.
  • Breast Cancer [ Time Frame: Within 10 years ] [ Designated as safety issue: Yes ]
    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.
arterial thromboembolism [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00676065 on ClinicalTrials.gov Archive Site
Not Provided
gynecological cancer [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Long-term Active Surveillance Study for Oral Contraceptives (LASS)
Long-term Active Surveillance Study for Oral Contraceptives (LASS)

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Women attending offices of oral contraceptives prescribing physicians

  • Arterial Thromboembolism
  • Venous Thromboembolism
  • Breast Cancer
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58303
December 2011
March 2011   (final data collection date for primary outcome measure)

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
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00676065
ZEG2006_03
Yes
Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
Center for Epidemiology and Health Research, Germany
Bayer
Principal Investigator: Juergen Dinger, MD, PhD Center for Epidemiology and Health Research Berlin, Germany
Center for Epidemiology and Health Research, Germany
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP