Trial record 13 of 747 for:    "Venous Thromboembolism"

Use of Oral Contraceptives (OCs) Containing Dienogest and Risk of Venous Thromboembolism

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by:
Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier:
NCT00523614
First received: August 30, 2007
Last updated: March 19, 2010
Last verified: March 2010
  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

Resource links provided by NLM:


Further study details as provided by Center for Epidemiology and Health Research, Germany:

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 ] [ 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
Study Population

Cases: women between 15 and 49 years old with a VTE diagnosed in Germany between 2002 and 2007

Controls: population sample

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523614

Locations
Germany
Center for Epidemilogy and Health Research
Berlin, Germany, 10115
Sponsors and Collaborators
Center for Epidemiology and Health Research, Germany
Bayer
Investigators
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:
Venous Thromboembolism
Venous Thrombosis
Thromboembolism
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 July 29, 2014