Venous Thromboembolism
Conditions
Keywords
venous thromboembolism
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Bayer
Center for Epidemiology and Health Research, Germany
Study design
Observational model
CASE_CONTROL
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* cases: women with a venous thromboembolism who are between 15 and 49 years old * control: women without a venous thromboembolism diagnosis who are between 15 and 49 years old
Exclusion criteria
* women outside the defined age range * women with severe language problems * women who are not willing to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk of Venous Thromboembolism (VTE) Between Women Who Use Dienogest/Ethinylestradiol (DNG/EE) and Women Who Use Other Low-dose Combined Oral Contraceptives (COC) | 01/2002 - 01/2008 | 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. |
Countries
Germany
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Cases Women with a venous thromboembolism who are between 15 and 49 years old | 680 |
| Controls Women without a venous thromboembolism diagnosis who are between 15 and 49 years old | 2,720 |
| Total | 3,400 |
Baseline characteristics
| Characteristic | Controls | Cases | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 60 Participants | 15 Participants | 75 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2660 Participants | 665 Participants | 3325 Participants |
| Age Continuous | 36.1 years STANDARD_DEVIATION 9 | 36.1 years STANDARD_DEVIATION 9 | 36.1 years STANDARD_DEVIATION 9 |
| Region of Enrollment Germany | 2720 participants | 680 participants | 3400 participants |
| Sex: Female, Male Female | 2720 Participants | 680 Participants | 3400 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 680 | 0 / 2,720 |
| serious Total, serious adverse events | 0 / 680 | 0 / 2,720 |
Outcome results
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.
Time frame: 01/2002 - 01/2008
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cases | Risk of Venous Thromboembolism (VTE) Between Women Who Use Dienogest/Ethinylestradiol (DNG/EE) and Women Who Use Other Low-dose Combined Oral Contraceptives (COC) | Exposed DNG/EE COC | 35 Participants |
| Cases | Risk of Venous Thromboembolism (VTE) Between Women Who Use Dienogest/Ethinylestradiol (DNG/EE) and Women Who Use Other Low-dose Combined Oral Contraceptives (COC) | Exposed low-dose COC | 161 Participants |
| Controls | Risk of Venous Thromboembolism (VTE) Between Women Who Use Dienogest/Ethinylestradiol (DNG/EE) and Women Who Use Other Low-dose Combined Oral Contraceptives (COC) | Exposed DNG/EE COC | 106 Participants |
| Controls | Risk of Venous Thromboembolism (VTE) Between Women Who Use Dienogest/Ethinylestradiol (DNG/EE) and Women Who Use Other Low-dose Combined Oral Contraceptives (COC) | Exposed low-dose COC | 423 Participants |
Comparison: Null hypothesis: OR ≥ 2 (VTE of DNG/EE vs. other low-dose COC)p-value: <0.0595% CI: [0.57, 1.39]Regression, Logistic