Venous ThrombosisNCT01297348
Study Of Lybrel In Relation To Venous Thromboembolism
An observational study of Venous Thrombosis and Pulmonary Embolism, run by Pfizer.
Trial summary
Lybrel® is an oral contraceptive that delivers low doses of levonorgestrel and ethinyl estradiol (90 μg/20 μg). Lybrel is taken on a continuous basis without a placebo or pill-free interval to inhibit menstrual cycle bleeding by delivering a steady level of the 2 hormones for as long as the drug is used. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Venous Thrombosis, Pulmonary Embolism, Sinus Thrombosis, Intracranial
- What is being tested?
- 90ug levonorgestrel / 20 ug ethinyl estradiol and Oral Contraceptives containing 20 ug of ethinyl estradiol
- Type of treatment
- Pill or oral medicine
- How many people
- 598,682 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Apr 2012
- 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 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: The base population for each year of the study will comprise all 15 - 49 year old women who have any recorded prescriptions for either continuous use ethinyl estradiol 20ug/levonorgestrel 90ug or a cyclic oral contraceptive that contains 20 µg ethinyl estradiol. The women are identified from PharMetrics and MarketScan databases. Additionally, women are enrolled if the index prescription is a new one; this is defined as a prescription dispensed following a 4-month window in which no combined hormonal contraception prescriptions were filled.
Who may be able to join
- New users of the study drugs (i.e., Lybrel and the comparison OCs)
Who cannot join
- No specific exclusion criteria for the base study cohort.
About this study
Official title: Postmarketing Study Of Lybrel In Relation To Venous Thromboembolism
Lybrel® is an oral contraceptive that delivers low doses of levonorgestrel and ethinyl estradiol (90 μg/20 μg). Lybrel is taken on a continuous basis without a placebo or pill-free interval to inhibit menstrual cycle bleeding by delivering a steady level of the 2 hormones for as long as the drug is used. Lybrel was marketed in the US in July of 2007. The objective of this database case-control study is to estimate the risk of idiopathic VTE (deep vein thrombosis and pulmonary embolism) in current users of Lybrel (ethinyl estradiol 20ug/levonorgestrel 90ug) compared to current users of other oral contraceptives containing 20μg of ethinyl estradiol.
Read the detailed description
The base population consists of all currently available data on current users (15-49 years old) of Lybrel and other oral contraceptives (OC) containing 20 µg ethinyl estradiol in the PharMetrics/IMS and MarketScan databases. From among the base population, the databases are then searched for any diagnosis of deep vein thrombosis (DVT), pulmonary embolism (PE), or cerebral venous sinus thrombosis (CVST) [referred to collectively as venous thromboembolism or VTE] that occurred after receipt of Lybrel or other oral contraceptives containing 20 µg ethinyl estradiol. The intent is to include newly diagnosed cases of VTE.
- Being tested
- 90ug levonorgestrel / 20 ug ethinyl estradiol, Oral Contraceptives containing 20 ug of ethinyl estradiol
- Keywords
- Lybrel, levonorgestrel, ethinyl estradiol, venus thromboembolism (VTE), oral contraceptives (OC), safety, database study, case-control study
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism, Sinus Thrombosis, Intracranial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
90ug levonorgestrel / 20 ug ethinyl estradiolDrug
Also called Lybrel
This is a non-interventional observational database study, thus no interventions are offered to patients in the study.
Oral Contraceptives containing 20 ug of ethinyl estradiolDrug
Also called Lessina, Aviane, Junel 1/20, Junel FE 1/20, Levlite, Lutera, Alesse, Loestrin FE 1/20, Loestrin 1/20, Microgestin 1/20, Microgestin FE 1/20
This is a non-interventional observational database study, thus no interventions are offered to patients in the study.
| Study group | Role | What they receive |
|---|---|---|
| Lybrel® | Current users of 90 ug levonorgestrel / 20 ug ethinyl estradiol - cases and controls (i.e., women diagnosed with new venus thromboembolism [VTE] and women not diagnosed with VTE). Receives: Drug: 90ug levonorgestrel / 20 ug ethinyl estradiol | |
| Other OCs containing 20μg of ethinyl estradiol | Current users of oral contraceptives containing 20μg of ethinyl estradiol - cases and controls (i.e. women diagnosed with new VTE and women not diagnosed with VTE) Receives: Drug: Oral Contraceptives containing 20 ug of ethinyl estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate of Idiopathic Venous Thromboembolism (VTE)
Idiopathic VTE=deep vein thrombosis (DVT), pulmonary embolism (PE), or cerebral venous sinus thrombosis (CVST) occurring in absence of known risk factors. Incidence rate reported for current, past users. Current user=had claim for study OC prescription (Lybrel or other OCs containing ethinyl estradiol 20 mcg) whose filled use occurred within 30 days prior to or at index date. Past user=had claim for a study OC prescription whose filled use occurred between 90 to 31 days prior to index date. Index date=date of VTE diagnosis for case and corresponding date for matched control.
Measured: Index date (date of VTE diagnosis for case and corresponding date for matched control)
Number of Idiopathic Venous Thromboembolism (VTE) Cases and Matched Controls
Idiopathic VTE cases=new DVT, PE or CVST occurring in absence of known risk factors. Matched Control was defined as participants with no diagnosis of VTE matched for age, calendar time, exposure status and database. Current user=had claim for study OC prescription (Lybrel or other OCs containing ethinyl estradiol 20 mcg) whose filled use occurred within 30 days prior to or at index date. Past user=had claim for a study OC prescription whose filled use occurred between 90 to 31 days prior to index date. Index date=date of VTE diagnosis for case and corresponding date for matched control.
Measured: Index date (date of VTE diagnosis for case and corresponding date for matched control)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startJul 2007
- Primary completionApr 2012
- Study completionApr 2012
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 ThrombosisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Time perspective
- Retrospective
- Enrolment
- 598,682 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston Collaborative Drug Surveillance Program
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297348
- Sponsor's protocol ID
- 0858A2-4406
- Other IDs
- B3121004
- Status last verified
- Jun 2013
- First submitted
- 14 Feb 2011
- Last updated
- 17 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postmarketing Study Of Lybrel In Relation To Venous Thromboembolism
- ClinicalTrials.gov ID
- NCT01297348
- Acronym / sponsor ID
- 0858A2-4406
- Keywords
- Lybrel, levonorgestrel, ethinyl estradiol, venus thromboembolism (VTE), oral contraceptives (OC), safety, database study, case-control study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 598,682 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Boston Collaborative Drug Surveillance Program
- Study start
- Jul 2007
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 16 Feb 2011 (estimated)
- Results
- Posted 27 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lybrel® is an oral contraceptive that delivers low doses of levonorgestrel and ethinyl estradiol (90 μg/20 μg). Lybrel is taken on a continuous basis without a placebo or pill-free interval to inhibit menstrual cycle bleeding by delivering a steady level of the 2 hormones for as long as the drug is used. Lybrel was marketed in the US in July of 2007. The objective of this database case-control study is to estimate the risk of idiopathic VTE (deep vein thrombosis and pulmonary embolism) in current users of Lybrel (ethinyl estradiol 20ug/levonorgestrel 90ug) compared to current users of other oral contraceptives containing 20μg of ethinyl estradiol.
Detailed description
The base population consists of all currently available data on current users (15-49 years old) of Lybrel and other oral contraceptives (OC) containing 20 µg ethinyl estradiol in the PharMetrics/IMS and MarketScan databases. From among the base population, the databases are then searched for any diagnosis of deep vein thrombosis (DVT), pulmonary embolism (PE), or cerebral venous sinus thrombosis (CVST) [referred to collectively as venous thromboembolism or VTE] that occurred after receipt of Lybrel or other oral contraceptives containing 20 µg ethinyl estradiol. The intent is to include newly diagnosed cases of VTE.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lybrel® | – | Drug: 90ug levonorgestrel / 20 ug ethinyl estradiolCurrent users of 90 ug levonorgestrel / 20 ug ethinyl estradiol - cases and controls (i.e., women diagnosed with new venus thromboembolism [VTE] and women not diagnosed with VTE). |
| Other OCs containing 20μg of ethinyl estradiol | – | Drug: Oral Contraceptives containing 20 ug of ethinyl estradiolCurrent users of oral contraceptives containing 20μg of ethinyl estradiol - cases and controls (i.e. women diagnosed with new VTE and women not diagnosed with VTE) |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The base population for each year of the study will comprise all 15 - 49 year old women who have any recorded prescriptions for either continuous use ethinyl estradiol 20ug/levonorgestrel 90ug or a cyclic oral contraceptive that contains 20 µg ethinyl estradiol. The women are identified from PharMetrics and MarketScan databases. Additionally, women are enrolled if the index prescription is a new one; this is defined as a prescription dispensed following a 4-month window in which no combined hormonal contraception prescriptions were filled.
Key inclusion criteria (1 listed)
- New users of the study drugs (i.e., Lybrel and the comparison OCs)
Key exclusion criteria (1 listed)
- No specific exclusion criteria for the base study cohort.
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 |
|---|---|---|
| 90ug levonorgestrel / 20 ug ethinyl estradiolAlso: LybrelThis is a non-interventional observational database study, thus no interventions are offered to patients in the study. | Drug | Lybrel® |
| Oral Contraceptives containing 20 ug of ethinyl estradiolAlso: Lessina, Aviane, Junel 1/20, Junel FE 1/20, Levlite, Lutera, Alesse, Loestrin FE 1/20, Loestrin 1/20, Microgestin 1/20, Microgestin FE 1/20This is a non-interventional observational database study, thus no interventions are offered to patients in the study. | Drug | Other OCs containing 20μg of ethinyl estradiol |
Primary outcome
Incidence Rate of Idiopathic Venous Thromboembolism (VTE)
Time frame: Index date (date of VTE diagnosis for case and corresponding date for matched control)
Idiopathic VTE=deep vein thrombosis (DVT), pulmonary embolism (PE), or cerebral venous sinus thrombosis (CVST) occurring in absence of known risk factors. Incidence rate reported for current, past users. Current user=had claim for study OC prescription (Lybrel or other OCs containing ethinyl estradiol 20 mcg) whose filled use occurred within 30 days prior to or at index date. Past user=had claim for a study OC prescription whose filled use occurred between 90 to 31 days prior to index date. Index date=date of VTE diagnosis for case and corresponding date for matched control.
Number of Idiopathic Venous Thromboembolism (VTE) Cases and Matched Controls
Time frame: Index date (date of VTE diagnosis for case and corresponding date for matched control)
Idiopathic VTE cases=new DVT, PE or CVST occurring in absence of known risk factors. Matched Control was defined as participants with no diagnosis of VTE matched for age, calendar time, exposure status and database. Current user=had claim for study OC prescription (Lybrel or other OCs containing ethinyl estradiol 20 mcg) whose filled use occurred within 30 days prior to or at index date. Past user=had claim for a study OC prescription whose filled use occurred between 90 to 31 days prior to index date. Index date=date of VTE diagnosis for case and corresponding date for matched control.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thrombosis and Pulmonary Embolism, run by Pfizer.
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 17 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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 27 May 2013). 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?
Incidence Rate of Idiopathic Venous Thromboembolism (VTE) (time frame: Index date (date of VTE diagnosis for case and corresponding date for matched control)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2013.