Arterial ThromboembolismNCT00676065

Long-term Active Surveillance Study for Oral Contraceptives (LASS)

An observational study of Arterial Thromboembolism and Venous Thromboembolism, run by Center for Epidemiology and Health Research, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to characterize and compare the risks of long-term use of oral contraceptives containing drospirenone and of other established oral contraceptives. Read more about this study

Who is it for?: Any age, women onlyHealthy volunteers can take part
Conditions the study is for: Arterial Thromboembolism, Venous Thromboembolism, Breast Cancer
Type of treatment: Pill or oral medicine
How many people: 58,303 participants
Where: 1 siteGermany
Study dates: Feb 2001to Dec 2011
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 attending offices of oral contraceptives prescribing physicians

Who may be able to join

Women who are prescribed an oral contraceptive and who are new users (first-ever users, switchers or restarters) of the formulation

Who cannot join

Women who do not consent to participate in the study

Trial locations and contacts

1 site in 1 country.

Germany1 site

Center for Epidemiology and Health Research
Berlin

Other trials in Germany

About this study

The objective of this study is to characterize and compare the risks of long-term use of oral contraceptives containing drospirenone and of other established oral contraceptives.

Read the detailed description

The LASS Study is a large, multinational, prospective, controlled, non-interventional, long-term cohort study that follows a series of cohorts. The cohorts consist of new users (first-ever users, switchers and restarters) of three different groups of oral contraceptives (OCs): OCs containing drospirenone (DRSP), OCs containing levonorgestrel (LNG) and OCs containing other progestogens. A "non-interference" approach is used to provide standardized, comprehensive, reliable information on these groups of OCs under routine medical conditions.

The main clinical outcomes of interest for the long-term follow-up are arterial and venous thromboembolism as well as breast cancer. Regular, active contacts with the cohort members (=active surveillance) provide all necessary information on health-related events or changes in health status.

The study is based on the existing long-term EURAS cohorts who are still in follow-up. LASS succeeds EURAS and prolongs the follow-up period for another five years. Total follow-up time of members of the long-term cohorts will be between 6 and 10 years. By means of annual contacts almost all relevant clinical outcomes will be captured. This will be accomplished by contacting the relevant physicians and by reviewing relevant source documents in the case of relevant clinical outcomes.

Conditions: Arterial Thromboembolism, Venous Thromboembolism, Breast Cancer
Keywords: Contraception, Thromboembolism, Breast Cancer
Medical subject headings: Venous Thromboembolism, Breast Neoplasms, Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00676065
Study group	Role	What they receive
1		Women who take oral contraceptives containing drospirenone
2		Women who take oral contraceptives containing levonorgestrel
3		Women who take oral contraceptives containing other progestogens

What is being measured

The primary outcome is the main question the study is designed to answer.

Arterial Thromboembolism
Arterial thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.
Measured: Within 10 years
Venous Thromboembolism
Venous thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.
Measured: Within 10 years
Breast Cancer
Breast cancer associated with the use of hormonal contraceptives either containing both drospirenone (DRSP) and ethinylestradiol (EE), levonorgestrel (LNG) or any other hormonal contraceptive without DRSP.
Measured: Within 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2001Dec 2011

First posted12 May 2008 (estimated)
Study startFeb 2001
Primary completionMar 2011
Study completionDec 2011

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 Arterial 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: Cohort
Time perspective: Prospective
Enrolment: 58,303 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00676065
Sponsor's protocol ID: ZEG2006_03
Status last verified: Nov 2014
First submitted: 8 May 2008
Last updated: 19 Nov 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Dinger J, Mohner S, Heinemann K. Cardiovascular risks associated with the use of drospirenone-containing combined oral contraceptives. Contraception. 2016 May;93(5):378-85. doi: 10.1016/j.contraception.2016.01.012. Epub 2016 Jan 26.
PubMed 26825258

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Arterial Thromboembolism trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-term Active Surveillance Study for Oral Contraceptives (LASS)
ClinicalTrials.gov ID: NCT00676065
Acronym / sponsor ID: ZEG2006_03
Conditions: Arterial Thromboembolism, Venous Thromboembolism, Breast Cancer
Keywords: Contraception, Thromboembolism, Breast Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 58,303 participants (actual)
Lead sponsor: Center for Epidemiology and Health Research, GermanyUniversity, hospital or other
Collaborators: Bayer
Study start: Feb 2001
Primary completion: Mar 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 12 May 2008 (estimated)
Results: Posted 19 Nov 2014

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 characterize and compare the risks of long-term use of oral contraceptives containing drospirenone and of other established oral contraceptives.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
1	–	–Women who take oral contraceptives containing drospirenone
2	–	–Women who take oral contraceptives containing levonorgestrel
3	–	–Women who take oral contraceptives containing other progestogens

Who may qualify

Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: Women attending offices of oral contraceptives prescribing physicians

Key inclusion criteria (1 listed)

Women who are prescribed an oral contraceptive and who are new users (first-ever users, switchers or restarters) of the formulation

Key exclusion criteria (1 listed)

Women who do not consent to participate in the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Arterial Thromboembolism
Time frame: Within 10 years
Arterial thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.
Venous Thromboembolism
Time frame: Within 10 years
Venous thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.
Breast Cancer
Time frame: Within 10 years
Breast cancer associated with the use of hormonal contraceptives either containing both drospirenone (DRSP) and ethinylestradiol (EE), levonorgestrel (LNG) or any other hormonal contraceptive without DRSP.

Results and safety

Results posted to the registry on 19 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Yasmin	16,534	16,534
OC-LNG	15,428	15,428
OC-other	26,341	26,341

Primary outcome: Arterial Thromboembolism

Time frame: Within 10 years. Number. Unit: participants

Measure	DRSP/EE n = 16534	OC-LNG n = 15428	OC-other n = 26341
Value	7	22	34

DRSP/EE vs OC-LNG: Hazard Ratio (HR): 0.4 (95% CI 0.2 to 0.9)
DRSP/EE vs OC-other: Hazard Ratio (HR): 0.4 (95% CI 0.2 to 0.9)

Population analysed: The number of participants refers to the ITT study population. During the course od the study, women could for example stop use of oral contraception at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.

Primary outcome: Venous Thromboembolism

Time frame: Within 10 years. Number. Unit: participants

Measure	DRSP/EE n = 16534	OC-LNG n = 15428	OC-other n = 26341
Value	56	53	144

DRSP/EE vs OC-LNG: Hazard Ratio (HR): 1.1 (95% CI 0.8 to 1.7)
DRSP/EE vs OC-other: Hazard Ratio (HR): 0.7 (95% CI 0.5 to 1.0)

Primary outcome: Breast Cancer

Time frame: Within 10 years. Number. Unit: participants

Measure	DRSP/EE n = 16534	OC-LNG n = 15428	OC-other n = 26341
Value	27	31	45

DRSP/EE vs OC-LNG: Hazard Ratio (HR): 0.9 (95% CI 0.5 to 1.4)
DRSP/EE vs OC-other: Hazard Ratio (HR): 1.0 (95% CI 0.6 to 1.5)

Adverse events

Time frame: Information on adverse events was collected over a time period of 10 years.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DRSP/EE	1,912 of 16,534 (11.6%)	0 of 16,534 (0%)	Not reported
OC-LNG	2,121 of 15,428 (13.7%)	0 of 15,428 (0%)	Not reported
OC-other	3,936 of 26,341 (14.9%)	0 of 26,341 (0%)	Not reported

Limitations and caveats (from the sponsor): In non-experimental studies the possibility of bias and residual confounding can never be entirely eliminated. The findings may exclude large, but not small relative risks.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26825258Dinger J, Mohner S, Heinemann K. Cardiovascular risks associated with the use of drospirenone-containing combined oral contraceptives. Contraception. 2016 May;93(5):378-85. doi: 10.1016/j.contraception.2016.01.012. Epub 2016 Jan 26.

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The Erlanger Stroke Registry (ESPro) is the Only Ongoing Prospective Population-based Stroke Registry in Germany, Started in 1994. ESPro Includes All Hospitalized and Non-hospitalized Patients With Stroke in the Community of Erlangen (120.000 Inhabitants), With a Long-life Follow-up.
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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 Berlin, Germany

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 Arterial Thromboembolism and Venous Thromboembolism, 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 1 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 19 Nov 2014. 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 19 Nov 2014). 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?

Arterial Thromboembolism (time frame: Within 10 years). The study lists 3 primary outcomes in all. 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 NCT00676065, 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 19 Nov 2014.