Breast CancerNCT00461253
Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Copper IUDs
An observational study of Breast Cancer, run by Center for Epidemiology and Health Research, Germany at 1 site in Germany.
Trial summary
The objective of this study is to determine the breast cancer risk of Mirena® users compared to copper intrauterine device (IUD) users in a community-based case-control study. Read more about this study
- Who is it for?
- Ages Up to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Levonorgestrel-releasing IUD and Copper IUD
- Type of treatment
- Medical device
- How many people
- 25,565 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2006to Mar 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Cases will be identified from population-based cancer registries, tumor centers and breast centers. Matched controls will be accrued from the same region as the case came from.
Who may be able to join
- cases: women with a breast cancer who are younger than 50 years of age at cancer diagnosis
- controls: women without a breast cancer diagnosis who are younger than 50 years at the time of the interview
Who cannot join
- women who are not willing to participate
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to determine the breast cancer risk of Mirena® users compared to copper intrauterine device (IUD) users in a community-based case-control study.
Read the detailed description
This is a community-based case-control study in Germany and Finland. Cases will be identified from cancer registries, tumor centers and breast centers. Matched controls will be accrued from the same region as the case came from. Breast cancer cases and their controls are women under 50 years of age without known history of malignancies.
Cases are women with a breast cancer who are younger than 50 years of age at cancer diagnosis. The breast cancer was diagnosed between January 2000 and December 2007. Only alive cases and cases in a sufficiently good health status to be interviewed are eligible for the study.
Controls are women without a breast cancer diagnosis who are younger than 50 years of age at the time of the interview. About 3 controls matched by year of birth and region will be allocated to each case.
A standardized questionnaire will be used for all breast cancer cases and controls. The questionnaire will be mailed to cases and controls.
Study participants will be asked for their informed consent. Data confidentiality according to national laws will be ensured by the field organizations.
- Conditions
- Breast Cancer
- Being tested
- Levonorgestrel-releasing IUD, Copper IUD
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel-releasing IUDDevice
Also called Mirena
This is a case-control-study; strictly speaking the category "intervention type" does not apply to this study.
Copper IUDDevice
This is a case-control-study; strictly speaking the category "intervention type" does not apply to this study.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Breast Cancer Cases Receives: Device: Levonorgestrel-releasing IUD; Device: Copper IUD | |
| 2 | Matched Controls for Breast Cancer Cases Receives: Device: Levonorgestrel-releasing IUD; Device: Copper IUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast Cancer Risk
Breast cancer (invasive carcinoma or carcinoma in situ) in women aged <50 years at diagnosis. Cases were excluded if they had died before study start or had a history of malignancy.
Measured: retrospective, January 2000 to December 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2007 (estimated)
- Study startOct 2006
- Primary completionMar 2014
- Study completionMar 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- 25,565 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Epidemiology and Health Research, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
- Investigators
- Juergen Dinger, MD, PhD, Principal investigator, Center for Epidemiology and Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461253
- Sponsor's protocol ID
- ZEG2006_02
- Status last verified
- Dec 2015
- First submitted
- 16 Apr 2007
- Last updated
- 25 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dinger J, Bardenheuer K, Minh TD. Levonorgestrel-releasing and copper intrauterine devices and the risk of breast cancer. Contraception. 2011 Mar;83(3):211-7. doi: 10.1016/j.contraception.2010.11.009. Epub 2011 Jan 7.
PubMed 21310281
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Copper IUDs
- ClinicalTrials.gov ID
- NCT00461253
- Acronym / sponsor ID
- ZEG2006_02
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25,565 participants (actual)
- Lead sponsor
- Center for Epidemiology and Health Research, GermanyUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Oct 2006
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 17 Apr 2007 (estimated)
- Results
- Posted 25 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine the breast cancer risk of Mirena® users compared to copper intrauterine device (IUD) users in a community-based case-control study.
Detailed description
This is a community-based case-control study in Germany and Finland. Cases will be identified from cancer registries, tumor centers and breast centers. Matched controls will be accrued from the same region as the case came from. Breast cancer cases and their controls are women under 50 years of age without known history of malignancies.
Cases are women with a breast cancer who are younger than 50 years of age at cancer diagnosis. The breast cancer was diagnosed between January 2000 and December 2007. Only alive cases and cases in a sufficiently good health status to be interviewed are eligible for the study.
Controls are women without a breast cancer diagnosis who are younger than 50 years of age at the time of the interview. About 3 controls matched by year of birth and region will be allocated to each case.
A standardized questionnaire will be used for all breast cancer cases and controls. The questionnaire will be mailed to cases and controls.
Study participants will be asked for their informed consent. Data confidentiality according to national laws will be ensured by the field organizations.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Levonorgestrel-releasing IUD, Device: Copper IUDBreast Cancer Cases |
| 2 | – | Device: Levonorgestrel-releasing IUD, Device: Copper IUDMatched Controls for Breast Cancer Cases |
Who may qualify
- Ages
- Up to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Cases will be identified from population-based cancer registries, tumor centers and breast centers. Matched controls will be accrued from the same region as the case came from.
Key inclusion criteria (2 listed)
- cases: women with a breast cancer who are younger than 50 years of age at cancer diagnosis
- controls: women without a breast cancer diagnosis who are younger than 50 years at the time of the interview
Key exclusion criteria (1 listed)
- women who are not willing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levonorgestrel-releasing IUDAlso: MirenaThis is a case-control-study; strictly speaking the category "intervention type" does not apply to this study. | Device | 1, 2 |
| Copper IUDThis is a case-control-study; strictly speaking the category "intervention type" does not apply to this study. | Device | 1, 2 |
Primary outcome
Breast Cancer Risk
Time frame: retrospective, January 2000 to December 2007
Breast cancer (invasive carcinoma or carcinoma in situ) in women aged <50 years at diagnosis. Cases were excluded if they had died before study start or had a history of malignancy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21310281Dinger J, Bardenheuer K, Minh TD. Levonorgestrel-releasing and copper intrauterine devices and the risk of breast cancer. Contraception. 2011 Mar;83(3):211-7. doi: 10.1016/j.contraception.2010.11.009. Epub 2011 Jan 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juergen Dinger, MD, PhD principal investigator
Center for Epidemiology and Health Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Center for Epidemiology and Health Research, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast Cancer Risk (time frame: retrospective, January 2000 to December 2007). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00461253, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2016.