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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Long-term Active Surveillance Study for Oral Contraceptives (LASS)|
- 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.
|Study Start Date:||February 2001|
|Study Completion Date:||December 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Women who take oral contraceptives containing drospirenone
Women who take oral contraceptives containing levonorgestrel
Women who take oral contraceptives containing other progestogens
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676065
|Center for Epidemiology and Health Research|
|Principal Investigator:||Juergen Dinger, MD, PhD||Center for Epidemiology and Health Research Berlin, Germany|