Study Of Lybrel In Relation To Venous Thromboembolism

Pfizer

Status: Completed

Conditions: Pulmonary Embolism; Sinus Thrombosis, Intracranial; Venous Thrombosis

Treatments: Drug: 90ug levonorgestrel / 20 ug ethinyl estradiol; Drug: Oral Contraceptives containing 20 ug of ethinyl estradiol

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01297348

B3121004

0858A2-4406

Details and patient eligibility

About

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.

Full 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.

Enrollment: 598,682 patients

Sex: Female

Ages: 15 to 49 years old

Volunteers: No Healthy Volunteers

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.

Trial design

598,682 participants in 2 patient groups

Lybrel®

Description:

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).

Treatment:

Drug: 90ug levonorgestrel / 20 ug ethinyl estradiol

Other OCs containing 20μg of ethinyl estradiol

Description:

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)

Treatment:

Drug: Oral Contraceptives containing 20 ug of ethinyl estradiol