This trial is active, not recruiting.

Conditions arterial thromboembolism, gynecological cancer
Sponsor Center for Epidemiology and Health Research, Germany
Collaborator Bayer
Start date February 2001
End date March 2011
Trial size 59510 participants
Trial identifier NCT00676065, ZEG2006_03


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Women who take oral contraceptives containing drospirenone
Women who take oral contraceptives containing levonorgestrel
Women who take oral contraceptives containing other progestogens

Primary Outcomes

arterial thromboembolism
time frame: Within 10 years

Secondary Outcomes

gynecological cancer
time frame: Within 10 years

Eligibility Criteria

Female participants of any age.

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

Additional Information

Official title Long-term Active Surveillance Study for Oral Contraceptives (LASS)
Principal investigator Juergen C Dinger, MD, PhD
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 (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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by Center for Epidemiology and Health Research, Germany.