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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676065
• Other study ID #: ZEG2006_03
• Status: Completed
• Phase: N/A
• First received: May 8, 2008
• Last updated: November 13, 2014
• Start date: February 2001
• Est. completion date: December 2011

Study information

• Verified date: November 2014
• Source: Center for Epidemiology and Health Research, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medicines Evaluation Board (MEB)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58303
• Est. completion date: December 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arterial Thromboembolism
• Breast Cancer
• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
Germany	Center for Epidemiology and Health Research	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Center for Epidemiology and Health Research, Germany	Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial Thromboembolism	Arterial thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.	Within 10 years	Yes
Primary	Venous Thromboembolism	Venous thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.	Within 10 years	Yes
Primary	Breast Cancer	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.	Within 10 years	Yes