Study Of Lybrel In Relation To Venous Thromboembolism

Study Overview
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Brief Summary
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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
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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.

Official Title
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Postmarketing Study Of Lybrel In Relation To Venous Thromboembolism

Conditions
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Venous Thrombosis, Pulmonary Embolism, Sinus Thrombosis, Intracranial

Intervention / Treatment
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* Drug: 90ug levonorgestrel / 20 ug ethinyl estradiol
* Drug: Oral Contraceptives containing 20 ug of ethinyl estradiol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New users of the study drugs (i.e., Lybrel and the comparison OCs) Exclusion Criteria: No specific exclusion criteria for the base study cohort.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lybrel®<br>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). | Drug: 90ug levonorgestrel / 20 ug ethinyl estradiol<br>* This is a non-interventional observational database study, thus no interventions are offered to patients in the study.<br>* Other names: Lybrel;|
| Other OCs containing 20μg of ethinyl estradiol<br>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) | Drug: Oral Contraceptives containing 20 ug of ethinyl estradiol<br>* This is a non-interventional observational database study, thus no interventions are offered to patients in the study.<br>* Other names: 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;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lybrel, levonorgestrel, ethinyl estradiol, venus thromboembolism (VTE), oral contraceptives (OC), safety, database study, case-control study