NCT01297348

Study Of Lybrel In Relation To Venous Thromboembolism

Postmarketing Study Of Lybrel In Relation To Venous Thromboembolism

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 598,682 (actual)
• Sponsor: Pfizer · Industry
• Sex: Female
• Age: 15 Years – 49 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Venous Thrombosis
• Pulmonary Embolism
• Sinus Thrombosis, Intracranial

Interventions

Type	Name	Description
DRUG	90ug levonorgestrel / 20 ug ethinyl estradiol	This is a non-interventional observational database study, thus no interventions are offered to patients in the study.
DRUG	Oral Contraceptives containing 20 ug of ethinyl estradiol	This is a non-interventional observational database study, thus no interventions are offered to patients in the study.

Timeline

• Start date: 2007-07-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-02-16
• Last updated: 2013-07-17
• Results posted: 2013-05-27