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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier:
NCT00676065
First received: May 8, 2008
Last updated: November 13, 2014
Last verified: November 2014
  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
Arterial Thromboembolism
Venous Thromboembolism
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Active Surveillance Study for Oral Contraceptives (LASS)

Resource links provided by NLM:


Further study details as provided by Center for Epidemiology and Health Research, Germany:

Primary Outcome Measures:
  • Arterial Thromboembolism [ Time Frame: Within 10 years ] [ Designated as safety issue: Yes ]
    Arterial thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.

  • Venous Thromboembolism [ Time Frame: Within 10 years ] [ Designated as safety issue: Yes ]
    Venous thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.

  • Breast Cancer [ Time Frame: Within 10 years ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 58303
Study Start Date: February 2001
Study Completion Date: December 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Women who take oral contraceptives containing drospirenone
2
Women who take oral contraceptives containing levonorgestrel
3
Women who take oral contraceptives containing other progestogens

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women attending offices of oral contraceptives prescribing physicians

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676065

Locations
Germany
Center for Epidemiology and Health Research
Berlin, Germany
Sponsors and Collaborators
Center for Epidemiology and Health Research, Germany
Bayer
Investigators
Principal Investigator: Juergen Dinger, MD, PhD Center for Epidemiology and Health Research Berlin, Germany
  More Information

No publications provided

Responsible Party: Juergen Dinger, MD, PhD, Principal Investigator, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier: NCT00676065     History of Changes
Other Study ID Numbers: ZEG2006_03
Study First Received: May 8, 2008
Results First Received: November 13, 2014
Last Updated: November 13, 2014
Health Authority: Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by Center for Epidemiology and Health Research, Germany:
Contraception
Thromboembolism
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Breast Diseases
Cardiovascular Diseases
Embolism and Thrombosis
Neoplasms
Neoplasms by Site
Skin Diseases
Thrombosis
Vascular Diseases
Contraceptive Agents
Contraceptives, Oral
Contraceptive Agents, Female
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014