ContraceptionNCT00302848
European Active Surveillance Study (EURAS)
An observational study of Contraception, run by Center for Epidemiology and Health Research, Germany at 1 site in Germany.
Trial summary
EURAS is a multi-national, controlled, prospective, post-marketing, non-intervention cohort study of new users of drospirenone/ethinylestradiol (DRSP/EE), levonorgestrel/ethinylestradiol (LNG/EE) and other oral contraceptives (OCs) under routine conditions of medical practice in seven European countries. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Drospirenone, Levonorgestrel and Other progestin containing oral contraceptive
- Type of treatment
- Pill or oral medicine
- How many people
- 59,510 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2000to Dec 2005
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women prescribed hormonal contraceptives
Who may be able to join
- Women starting OC use or women switching OCs
- Women willing to participate in the active surveillance for several years
Who cannot join
- Women who have contraindications for OC use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The European Active Surveillance Study on OC Prescribing Practice, Benefits and Safety (EURAS)
EURAS is a multi-national, controlled, prospective, post-marketing, non-intervention cohort study of new users of drospirenone/ethinylestradiol (DRSP/EE), levonorgestrel/ethinylestradiol (LNG/EE) and other oral contraceptives (OCs) under routine conditions of medical practice in seven European countries. Baseline survey and semiannual, active follow-up are based on postal questionnaires, with validation of reported events by the women's treating physicians. A multifaceted 4-level follow-up procedure will be established to ensure low loss to follow-up rates. The objective of the study is the investigation of the incidence of rare serious adverse events associated with the use of new and established OCs, and specifically the incidence of thromboembolic events.
Read the detailed description
Active surveillance using valid epidemiologic study designs is desirable for any new product, because adverse effects may occur that have not yet been identified in pre-marketing studies.
The EURAS study investigates the safety of oral contraceptives with a large cohort of women attending offices of prescribing physicians. Its primary objective will be to compare incidence rates of adverse events in users of so-called new OCs and users of other OCs. The study is conducted as a phase IV commitment to the European Drug Authorities.
The combined cohort will include 50,000 to 60,000 women recruited by a selected set of physicians in six European countries. A total of more than 1,500,000 cycles are expected to be observed during the field work which will start early in 2001 and end early in 2006.
The participating women will undergo a baseline survey using a self administered questionnaire to describe the baseline risk. Every six months they will fill out a questionnaire in which they will record complaints and events during the use of the prescribed OC which will be validated. A multifaceted 4-level follow-up procedure will be established to ensure low loss to follow-up rates.
Based on experience obtained in previous OC studies complex sources of bias and confounding are expected. Thus, multivariate methods such as Cox regression will be used to adjust for confounding. Regarding the impact of the results on public health, the main emphasis will be on the absolute risk estimates.
- Conditions
- Contraception
- Being tested
- Drospirenone, Levonorgestrel, Other progestin containing oral contraceptive
- Keywords
- Venous thromboembolism, Drospirenone
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrospirenoneDrug
LevonorgestrelDrug
Other progestin containing oral contraceptiveDrug
| Study group | Role | What they receive |
|---|---|---|
| Users of Drospirenone (DRSP) | Not described Receives: Drug: Drospirenone | |
| Users of Levonorgestrel (LNG) | Not described Receives: Drug: Levonorgestrel | |
| Users of other oral contraceptives (OCs) | Not described Receives: Drug: Other progestin containing oral contraceptive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Venous Thromboembolism (VTE)
Measured: 1.5 to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2006 (estimated)
- Study startNov 2000
- Study completionDec 2005
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 (2)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59,510 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Epidemiology and Health Research, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Investigators
- Juergen C Dinger, MD, PhD, Principal investigator, Center for Epidemiology and Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302848
- Sponsor's protocol ID
- ZEG 2000_1
- Status last verified
- Nov 2009
- First submitted
- 13 Mar 2006
- Last updated
- 20 Nov 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Heinemann LA, Dinger J. Safety of a new oral contraceptive containing drospirenone. Drug Saf. 2004;27(13):1001-18. doi: 10.2165/00002018-200427130-00003.
PubMed 15471507Dinger JC, Heinemann LA, Kuhl-Habich D. The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance Study on oral contraceptives based on 142,475 women-years of observation. Contraception. 2007 May;75(5):344-54. doi: 10.1016/j.contraception.2006.12.019. Epub 2007 Feb 23.
PubMed 17434015
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The European Active Surveillance Study on OC Prescribing Practice, Benefits and Safety (EURAS)
- ClinicalTrials.gov ID
- NCT00302848
- Acronym / sponsor ID
- ZEG 2000_1
- Conditions
- Contraception
- Keywords
- Venous thromboembolism, Drospirenone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59,510 participants (actual)
- Lead sponsor
- Center for Epidemiology and Health Research, GermanyUniversity, hospital or other
- Collaborators
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Study start
- Nov 2000
- Study completion
- Dec 2005
- First posted
- 15 Mar 2006 (estimated)
- Results
- Posted 20 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
EURAS is a multi-national, controlled, prospective, post-marketing, non-intervention cohort study of new users of drospirenone/ethinylestradiol (DRSP/EE), levonorgestrel/ethinylestradiol (LNG/EE) and other oral contraceptives (OCs) under routine conditions of medical practice in seven European countries. Baseline survey and semiannual, active follow-up are based on postal questionnaires, with validation of reported events by the women's treating physicians. A multifaceted 4-level follow-up procedure will be established to ensure low loss to follow-up rates. The objective of the study is the investigation of the incidence of rare serious adverse events associated with the use of new and established OCs, and specifically the incidence of thromboembolic events.
Detailed description
Active surveillance using valid epidemiologic study designs is desirable for any new product, because adverse effects may occur that have not yet been identified in pre-marketing studies.
The EURAS study investigates the safety of oral contraceptives with a large cohort of women attending offices of prescribing physicians. Its primary objective will be to compare incidence rates of adverse events in users of so-called new OCs and users of other OCs. The study is conducted as a phase IV commitment to the European Drug Authorities.
The combined cohort will include 50,000 to 60,000 women recruited by a selected set of physicians in six European countries. A total of more than 1,500,000 cycles are expected to be observed during the field work which will start early in 2001 and end early in 2006.
The participating women will undergo a baseline survey using a self administered questionnaire to describe the baseline risk. Every six months they will fill out a questionnaire in which they will record complaints and events during the use of the prescribed OC which will be validated. A multifaceted 4-level follow-up procedure will be established to ensure low loss to follow-up rates.
Based on experience obtained in previous OC studies complex sources of bias and confounding are expected. Thus, multivariate methods such as Cox regression will be used to adjust for confounding. Regarding the impact of the results on public health, the main emphasis will be on the absolute risk estimates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Users of Drospirenone (DRSP) | – | Drug: Drospirenone |
| Users of Levonorgestrel (LNG) | – | Drug: Levonorgestrel |
| Users of other oral contraceptives (OCs) | – | Drug: Other progestin containing oral contraceptive |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women prescribed hormonal contraceptives
Key inclusion criteria (2 listed)
- Women starting OC use or women switching OCs
- Women willing to participate in the active surveillance for several years
Key exclusion criteria (1 listed)
- Women who have contraindications for OC use
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 |
|---|---|---|
| Drospirenone | Drug | Users of Drospirenone (DRSP) |
| Levonorgestrel | Drug | Users of Levonorgestrel (LNG) |
| Other progestin containing oral contraceptive | Drug | Users of other oral contraceptives (OCs) |
Primary outcome
Number of Participants With Venous Thromboembolism (VTE)
Time frame: 1.5 to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 15471507Heinemann LA, Dinger J. Safety of a new oral contraceptive containing drospirenone. Drug Saf. 2004;27(13):1001-18. doi: 10.2165/00002018-200427130-00003.
- Results publication: PubMed 17434015Dinger JC, Heinemann LA, Kuhl-Habich D. The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance Study on oral contraceptives based on 142,475 women-years of observation. Contraception. 2007 May;75(5):344-54. doi: 10.1016/j.contraception.2006.12.019. Epub 2007 Feb 23.
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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 C 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 Contraception, 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 20 Nov 2009. 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 20 Nov 2009). 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?
Number of Participants With Venous Thromboembolism (VTE) (time frame: 1.5 to 5 years). 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 NCT00302848, which also lists 2 linked publications.
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 20 Nov 2009.