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| Sponsors and Collaborators: |
Center for Epidemiology and Health Research, Germany Bayer Schering Pharmaceutical |
|---|---|
| Information provided by: | Center for Epidemiology and Health Research, Germany |
| ClinicalTrials.gov Identifier: | NCT00676065 |
Purpose
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.
| Condition |
|---|
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Arterial Thromboembolism Gynecological Cancer |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Long-Term Active Surveillance Study for Oral Contraceptives (LASS) |
| Enrollment: | 59510 |
| Study Start Date: | February 2001 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Women who take oral contraceptives containing drospirenone
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2
Women who take oral contraceptives containing levonorgestrel
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3
Women who take oral contraceptives containing other progestogens
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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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Women attending offices of oral contraceptives prescribing physicians
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| Center for Epidemiology and Health Research | |
| Berlin, Germany | |
| Principal Investigator: | Juergen C Dinger, MD, PhD | Center for Epidemiology and Health Research Berlin, Germany |
More Information
| Responsible Party: | Center for Epidemiology and Health Research, Germany ( Juergen C Dinger, MD, PhD, Principal Investigator ) |
| Study ID Numbers: | ZEG2006_03 |
| Study First Received: | May 8, 2008 |
| Last Updated: | May 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00676065 |
| Health Authority: | Netherlands: Medicines Evaluation Board (MEB) |
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Contraception Arterial Thromboembolism Gynecological Cancer |
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Embolism and Thrombosis Embolism Vascular Diseases Thrombosis Thromboembolism |
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Cardiovascular Diseases |
