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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00676065
Other study ID # ZEG2006_03
Secondary ID
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


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
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