Use of Oral Contraceptives (OCs) Containing Dienogest and Risk of Venous Thromboembolism
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Purpose
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.
| Condition |
|---|
|
Venous Thromboembolism |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control |
| Official Title: | Use of OCs Containing Dienogest and Risk of Venous Thromboembolism |
- Risk of Venous Thromboembolism (VTE) Between Women Who Use Dienogest/Ethinylestradiol (DNG/EE) and Women Who Use Other Low-dose Combined Oral Contraceptives (COC) [ Time Frame: 01/2002 - 01/2008 ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 3400 |
| Study Start Date: | July 2007 |
| Study Completion Date: | June 2008 |
| Groups/Cohorts |
|---|
| 1: Cases |
| 2: Controls |
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.
Eligibility| Ages Eligible for Study: | 15 Years to 49 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Cases: women between 15 and 49 years old with a VTE diagnosed in Germany between 2002 and 2007
Controls: population sample
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
Contacts and Locations| Germany | |
| Center for Epidemilogy and Health Research | |
| Berlin, Germany, 10115 | |
| Principal Investigator: | Juergen C Dinger, MD, PhD | Center for Epidemiology and Health Research |
More Information
No publications provided
| Responsible Party: | Juergen C Dinger, MD, PhD, Principal Investigator, Center for Epidemiology and Health Research, Germany |
| ClinicalTrials.gov Identifier: | NCT00523614 History of Changes |
| Other Study ID Numbers: | ZEG2007_02 |
| Study First Received: | August 30, 2007 |
| Results First Received: | June 22, 2009 |
| Last Updated: | March 19, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Center for Epidemiology and Health Research, Germany:
|
venous thromboembolism |
Additional relevant MeSH terms:
|
Thromboembolism Venous Thromboembolism Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thrombosis Contraceptives, Oral Dienogest Contraceptive Agents, Female |
Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Contraceptive Agents, Male |
ClinicalTrials.gov processed this record on May 16, 2013