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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
Results First Received: November 13, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Arterial Thromboembolism
Venous Thromboembolism
Breast Cancer

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
In the LASS study, 59,510 women were recruited overall. Of these, 836 participants were excluded due to protocol violation (e.g. patient did not start OC use). Furthermore, 371 patients started treatment with non-oral contraceptives. These patients were followed-up but were not part of the per protocol Population (58,303 patients).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Yasmin Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
OC-LNG Users of oral contraceptives containing levonorgestrel
OC-other Users of oral contraceptives containing other progestogens

Participant Flow:   Overall Study
    Yasmin     OC-LNG     OC-other  
STARTED     16534     15428     26341  
COMPLETED     16534     15428     26341  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
DRSP/EE Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
OC-LNG Users of oral contraceptives containing levonorgestrel
OC-other Users of oral contraceptives containing other progestogens
Total Total of all reporting groups

Baseline Measures
    DRSP/EE     OC-LNG     OC-other     Total  
Number of Participants  
[units: participants]
  16534     15428     26341     58303  
Age  
[units: years]
Mean ± Standard Deviation
  25.9  ± 8.1     25.1  ± 8.7     24.8  ± 7.8     25.2  ± 8.2  
Gender  
[units: participants]
       
Female     16534     15428     26341     58303  
Male     0     0     0     0  
Region of Enrollment [1]
[units: participants]
       
Europe     16534     15428     26341     58303  
[1] This study was conducted in seven European countries: Austria, Belgium, Denmark, France, Germany, the Netherlands, and UK.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Arterial Thromboembolism   [ Time Frame: Within 10 years ]

2.  Primary:   Venous Thromboembolism   [ Time Frame: Within 10 years ]

3.  Primary:   Breast Cancer   [ Time Frame: Within 10 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
In non-experimental studies the possibility of bias and residual confounding can never be entirely eliminated. The findings may exclude large, but not small relative risks.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Juergen Dinger, MD, PhD
Organization: Center for Epidemiology and Health Research Germany
phone: +49 30 945 101 20
e-mail: dinger@zeg-berlin.de


No publications provided


Responsible Party: Juergen Dinger, MD, PhD, 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)