Venous ThromboembolismNCT00523614
Use of Oral Contraceptives (OCs) Containing Dienogest and Risk of Venous Thromboembolism
An observational study of Venous Thromboembolism, run by Center for Epidemiology and Health Research, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Venous Thromboembolism
- How many people
- 3,400 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2007to Jun 2008
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Cases: women between 15 and 49 years old with a VTE diagnosed in Germany between 2002 and 2007 Controls: population sample
Who may be able to join
- 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
Who cannot join
- women outside the defined age range
- women with severe language problems
- women who are not willing to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of OCs Containing Dienogest and Risk of Venous Thromboembolism
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.
Read the 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.
- Conditions
- Venous Thromboembolism
- Keywords
- venous thromboembolism
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1: Cases | Not described | |
| 2: Controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 01/2002 - 01/2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2007 (estimated)
- Study startJul 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 3,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Epidemiology and Health Research, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Investigators
- Juergen C Dinger, MD, PhD, Principal investigator, Center for Epidemiology and Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523614
- Sponsor's protocol ID
- ZEG2007_02
- Status last verified
- Mar 2010
- First submitted
- 30 Aug 2007
- Last updated
- 23 Mar 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No