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

Completed

• Conditions: Arterial Thromboembolism; Breast Cancer; Venous Thromboembolism

• Registration Number: NCT00676065
• Lead Sponsor: Center for Epidemiology and Health Research, Germany

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.

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 Timeline

• Study Start: 2001-02
• Study First Submitted: 2008-05-08
• Study First Submitted QC: 2008-05-09
• Study First Posted: 2008-05-12
• Primary Completion: 2011-03
• Study Completion: 2011-12
• Status Verified: 2014-11
• Results First Submitted: 2014-11-13
• Results First Submitted QC: 2014-11-13
• Last Update Submitted: 2014-11-13
• Results First Posted: 2014-11-19
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58303

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Arterial Thromboembolism	Within 10 years	Arterial thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.
Venous Thromboembolism	Within 10 years	Venous thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.
Breast Cancer	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.

Trial Locations

Locations (1)

Center for Epidemiology and Health Research; 🇩🇪 Berlin, Germany