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

History of Changes

Results First Received: June 22, 2009

Study Type:	Observational
Study Design:	Observational Model: Case Control
Condition:	Venous Thromboembolism

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Cases	Women with a venous thromboembolism who are between 15 and 49 years old
Controls	Women without a venous thromboembolism diagnosis who are between 15 and 49 years old

Participant Flow: Overall Study

	Cases	Controls
STARTED	680 ^[1]	2720 ^[1]
COMPLETED	680 ^[1]	2720 ^[1]
NOT COMPLETED	0	0

[1]	As this is a case-control study the categories "started" and "completed" are not really applicable.

Baseline Characteristics

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Reporting Groups

	Description
Cases	Women with a venous thromboembolism who are between 15 and 49 years old
Controls	Women without a venous thromboembolism diagnosis who are between 15 and 49 years old
Total	Total of all reporting groups

Baseline Measures

	Cases	Controls	Total
Number of Participants [units: participants]	680	2720	3400
Age [units: participants]
<=18 years	15	60	75
Between 18 and 65 years	665	2660	3325
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	36.1 ± 9.0	36.1 ± 9.0	36.1 ± 9.0
Gender [units: participants]
Female	680	2720	3400
Male	0	0	0
Region of Enrollment [units: participants]
Germany	680	2720	3400

Outcome Measures

1. 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) [ Time Frame: 01/2002 - 01/2008 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This is an observational study. The possibility of bias and residual confounding cannot be entirely eliminated.

Results Point of Contact:

Name/Title: Juergen Dinger, MD, PhD, Principal Investigator
Organization: Berlin Center for Epidemiology and Health Research, Germany
phone: +49 30 94510145
e-mail: dinger@zeg-berlin.de

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

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