Study Of Lybrel In Relation To Venous Thromboembolism
Postmarketing Study Of Lybrel In Relation To Venous Thromboembolism
2 other identifiers
observational
598,682
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2007
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 14, 2011
CompletedFirst Posted
Study publicly available on registry
February 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
May 27, 2013
CompletedJuly 17, 2013
June 1, 2013
4.8 years
February 14, 2011
April 2, 2013
June 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
Index date (date of VTE diagnosis for case and corresponding date for matched control)
Study Arms (2)
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).
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)
Interventions
This is a non-interventional observational database study, thus no interventions are offered to patients in the study.
This is a non-interventional observational database study, thus no interventions are offered to patients in the study.
Eligibility Criteria
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.
You may qualify if:
- New users of the study drugs (i.e., Lybrel and the comparison OCs)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Boston Collaborative Drug Surveillance Programcollaborator
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Data for DVT, PE and CVST were not reported separately as the 3 were components of the primary endpoint VTE and not separate endpoints.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2011
First Posted
February 16, 2011
Study Start
July 1, 2007
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
July 17, 2013
Results First Posted
May 27, 2013
Record last verified: 2013-06