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Trial record 77 of 101 for:    DROSPIRENONE AND ETHINYL ESTRADIOL

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00676065
Recruitment Status : Completed
First Posted : May 12, 2008
Results First Posted : November 19, 2014
Last Update Posted : November 19, 2014
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany

Tracking Information
First Submitted Date May 8, 2008
First Posted Date May 12, 2008
Results First Submitted Date November 13, 2014
Results First Posted Date November 19, 2014
Last Update Posted Date November 19, 2014
Study Start Date February 2001
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 13, 2014)
  • Arterial Thromboembolism [ Time Frame: Within 10 years ]
    Arterial thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.
  • Venous Thromboembolism [ Time Frame: Within 10 years ]
    Venous thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.
  • 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.
Original Primary Outcome Measures
 (submitted: May 9, 2008)
Arterial Thromboembolism
Change History Complete list of historical versions of study NCT00676065 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: May 9, 2008)
gynecological cancer
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long-term Active Surveillance Study for Oral Contraceptives (LASS)
Official Title Long-term Active Surveillance Study for Oral Contraceptives (LASS)
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women attending offices of oral contraceptives prescribing physicians
Condition
  • Arterial Thromboembolism
  • Venous Thromboembolism
  • Breast Cancer
Intervention Not Provided
Study 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
Publications * Dinger J, Möhner 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 13, 2014)
58303
Original Actual Enrollment
 (submitted: May 9, 2008)
59510
Actual Study Completion Date December 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00676065
Other Study ID Numbers ZEG2006_03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
Study Sponsor Center for Epidemiology and Health Research, Germany
Collaborators Bayer
Investigators
Principal Investigator: Juergen Dinger, MD, PhD Center for Epidemiology and Health Research Berlin, Germany
PRS Account Center for Epidemiology and Health Research, Germany
Verification Date November 2014