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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The objective of this study is to compare the risk of venous thromboembolism (VTE) of oral contraceptives with non-use, focusing specifically on Valette® compared to other users of low estrogen dose combined oral contraceptives.
This is a population-based case-control study in Germany.
Cases are women who are between 15 and 49 years old with a diagnosis of venous thromboembolism (VTE). The VTE is diagnosed in Germany between January 2002 und December 2007.
Controls are women who are between 15 and 49 years old without a VTE diagnosis. About 4 controls matched by year of birth and region will be allocated to each case.
Both cases and controls will receive a similar self-administered questionnaire except of some case-specific questions which are not applicable for the controls.
Study participants will be asked for their informed consent. Data confidentiality will be ensured by the Berlin Center for Epidemiology and Health Research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Cases | |||
| 2: Controls |
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| Measure | Description | Time Frame |
|---|---|---|
| Risk of Venous Thromboembolism (VTE) Between Women Who Use Dienogest/Ethinylestradiol (DNG/EE) and Women Who Use Other Low-dose Combined Oral Contraceptives (COC) | The time frame is the time when venous thromboembolism (VTE) was diagnosed in the cases group. VTE includes deep venous thrombosis and pulmonary embolism. These clinical endpoints were established by magnetic resonance imaging, spiral computer tomography, duplex sonography, and lung scintigraphy. | 01/2002 - 01/2008 |
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Inclusion Criteria:
Exclusion Criteria:
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Cases: women between 15 and 49 years old with a VTE diagnosed in Germany between 2002 and 2007
Controls: population sample
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| Name | Affiliation | Role |
|---|---|---|
| Juergen C Dinger, MD, PhD | Center for Epidemiology and Health Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Epidemilogy and Health Research | Berlin | 10115 | Germany |
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Identification started in spring 2007 and ended in January 2008. Cases (VTE=venous thromboembolism diagnosed in Germany between 01/2002 and 01/2008) were identified by primary care physicians. For each case 4 community-based controls (no VTE between 01/2002 and 01/2008) were selected.The controls were identified from randomly selected households.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cases | Women with a venous thromboembolism who are between 15 and 49 years old |
| FG001 | Controls | Women without a venous thromboembolism diagnosis who are between 15 and 49 years old |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cases | Women with a venous thromboembolism who are between 15 and 49 years old |
| BG001 | Controls | Women without a venous thromboembolism diagnosis who are between 15 and 49 years old |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Risk of Venous Thromboembolism (VTE) Between Women Who Use Dienogest/Ethinylestradiol (DNG/EE) and Women Who Use Other Low-dose Combined Oral Contraceptives (COC) | The time frame is the time when venous thromboembolism (VTE) was diagnosed in the cases group. VTE includes deep venous thrombosis and pulmonary embolism. These clinical endpoints were established by magnetic resonance imaging, spiral computer tomography, duplex sonography, and lung scintigraphy. | Posted | Number | Participants | 01/2002 - 01/2008 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cases | Women with a venous thromboembolism who are between 15 and 49 years old |
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This is an observational study. The possibility of bias and residual confounding cannot be entirely eliminated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Juergen Dinger, MD, PhD, Principal Investigator | Berlin Center for Epidemiology and Health Research, Germany | +49 30 94510145 | dinger@zeg-berlin.de |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 680 |
| 0 |
| 680 |
| EG001 | Controls | Women without a venous thromboembolism diagnosis who are between 15 and 49 years old | 0 | 2,720 | 0 | 2,720 |
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