Clinical trial NCT00676065: Long-term Active Surveillance Study for Oral Contraceptives (LASS)
Official title: Long-term Active Surveillance Study for Oral Contraceptives (LASS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Thromboembolism
Venous Thromboembolism
Breast Cancer
Keywords: Contraception
Thromboembolism
Breast Cancer
Lead sponsor: Center for Epidemiology and Health Research, Germany
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2008-05-12
Enrollment: 58303
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women attending offices of oral contraceptives prescribing physicians

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.

Eligibility criteria: 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

Primary outcomes:
measure: Arterial Thromboembolism
timeFrame: Within 10 years
measure: Venous Thromboembolism
timeFrame: Within 10 years
measure: Breast Cancer
timeFrame: Within 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Center for Epidemiology and Health Research
Study officials:
affiliation: Center for Epidemiology and Health Research Berlin, Germany
name: Juergen Dinger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dinger J, Mohner S, Heinemann K. Cardiovascular risks associated with the use of drospirenone-containing combined oral contraceptives. Contraception. 2016 May;93(5):378-85. doi: 10.1016/j.contraception.2016.01.012. Epub 2016 Jan 26.