Study Of Lybrel In Relation To Venous Thromboembolism

Last updated: June 27, 2013
Sponsor: Pfizer
Overall Status: Completed

Phase

N/A

Condition

Venous Thrombosis

Chest Pain

Occlusions

Treatment

N/A

Clinical Study ID

NCT01297348
0858A2-4406
B3121004
  • Ages 15-49
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • New users of the study drugs (i.e., Lybrel and the comparison OCs)

Exclusion

Exclusion Criteria:

  • No specific exclusion criteria for the base study cohort.

Study Design

Total Participants: 598682
Study Start date:
July 01, 2007
Estimated Completion Date:
April 30, 2012

Study 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.