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

This study is ongoing, but not recruiting participants.
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: October 24, 2011
Last verified: October 2011
History of Changes

May 8, 2008
October 24, 2011
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 [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00676065 on ClinicalTrials.gov Archive Site
gynecological cancer [ Time Frame: Within 10 years ] [ Designated as safety issue: Yes ]
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 (starters and switchers) 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 cardiovascular events (e.g. myocardial infarction) and gynecological 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
  • Gynecological 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.
 
Active, not recruiting
59510
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 (starters or switchers) 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 C Dinger, MD, PhD Center for Epidemiology and Health Research Berlin, Germany
Center for Epidemiology and Health Research, Germany
October 2011

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