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.

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Key information

Conditions

Venous Thrombosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism Embolism and Thrombosis Intracranial Embolism and Thrombosis Intracranial Thrombosis Lung Diseases Nervous System Diseases Pulmonary Embolism Respiratory Tract Diseases Sinus Thrombosis, Intracranial Thromboembolism Thrombosis Vascular Diseases

Age range

15 year–49 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

90ug levonorgestrel / 20 ug ethinyl estradiol

Drug

This is a non-interventional observational database study, thus no interventions are offered to patients in the study.

Other names: Lybrel

Oral Contraceptives containing 20 ug of ethinyl estradiol

Drug

This is a non-interventional observational database study, thus no interventions are offered to patients in the study.

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

Boston Collaborative Drug Surveillance Program

Registry information

Official study title

Postmarketing Study Of Lybrel In Relation To Venous Thromboembolism

Important dates

Study start: 2007
Primary completion: 2012
Study completion: 2012
First posted: Feb 16, 2011
Registry last updated: Jul 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed