Use of Oral Contraceptives (OCs) Containing Dienogest and Risk of Venous Thromboembolism
|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: NCT00523614|
Recruitment Status : Completed
First Posted : August 31, 2007
Results First Posted : December 2, 2009
Last Update Posted : March 23, 2010
|First Submitted Date||August 30, 2007|
|First Posted Date||August 31, 2007|
|Results First Submitted Date||June 22, 2009|
|Results First Posted Date||December 2, 2009|
|Last Update Posted Date||March 23, 2010|
|Study Start Date||July 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||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 ]
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.
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00523614 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Use of Oral Contraceptives (OCs) Containing Dienogest and Risk of Venous Thromboembolism|
|Official Title||Use of OCs Containing Dienogest and Risk of 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.|
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.
|Study Design||Observational Model: Case Control|
|Target Follow-Up Duration||Not Provided|
|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
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Estimated Enrollment
|Actual Study Completion Date||June 2008|
|Primary Completion Date||Not Provided|
|Ages||15 Years to 49 Years (Child, Adult)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||Germany|
|Removed Location Countries|
|Other Study ID Numbers||ZEG2007_02|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Juergen C Dinger, MD, PhD, Principal Investigator, Center for Epidemiology and Health Research, Germany|
|Study Sponsor||Center for Epidemiology and Health Research, Germany|
|PRS Account||Center for Epidemiology and Health Research, Germany|
|Verification Date||March 2010|