Clinical trial NCT01297348: Study Of Lybrel In Relation To Venous Thromboembolism
Official title: Postmarketing Study Of Lybrel In Relation To Venous Thromboembolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thrombosis
Pulmonary Embolism
Sinus Thrombosis, Intracranial
Keywords: Lybrel
levonorgestrel
ethinyl estradiol
venus thromboembolism (VTE)
oral contraceptives (OC)
safety
database study
case-control study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Boston Collaborative Drug Surveillance Program
First posted: 2011-02-16
Enrollment: 598682
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The base population for each year of the study will comprise all 15 - 49 year old women who have any recorded prescriptions for either continuous use ethinyl estradiol 20ug/levonorgestrel 90ug or a cyclic oral contraceptive that contains 20 µg ethinyl estradiol. The women are identified from PharMetrics and MarketScan databases. Additionally, women are enrolled if the index prescription is a new one; this is defined as a prescription dispensed following a 4-month window in which no combined hormonal contraception prescriptions were filled.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence Rate of Idiopathic Venous Thromboembolism (VTE)
timeFrame: Index date (date of VTE diagnosis for case and corresponding date for matched control)
measure: Number of Idiopathic Venous Thromboembolism (VTE) Cases and Matched Controls
timeFrame: Index date (date of VTE diagnosis for case and corresponding date for matched control)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: