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Completed

NCT Number: NCT00676065

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

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.

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Key information

Conditions

Arterial Thromboembolism Breast Cancer Breast Diseases Breast Neoplasms Cardiovascular Diseases Embolism and Thrombosis Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Thromboembolism Vascular Diseases Venous Thromboembolism

Sex eligibility

Female

Study type

Observational

Primary location

Center for Epidemiology and Health Research

Berlin, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Arterial Thromboembolism

    Time frame: Within 10 years

    Arterial thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.

  2. Venous Thromboembolism

    Time frame: Within 10 years

    Venous thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.

  3. Breast Cancer

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Center for Epidemiology and Health Research, Germany

Other

Collaborators

  • Bayer

Registry information

Important dates

Study start
2001
Primary completion
2011
Study completion
2011
First posted
May 12, 2008
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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