Study Of Lybrel In Relation To Venous Thromboembolism

Pulmonary Embolism Clinical Trial

Official title:

Postmarketing Study Of Lybrel In Relation To Venous Thromboembolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01297348
• Other study ID #: 0858A2-4406
• Secondary ID: B3121004
• Status: Completed
• Phase: N/A
• First received: February 14, 2011
• Last updated: June 27, 2013
• Start date: July 2007
• Est. completion date: April 2012

Study information

• Verified date: June 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01316640

Recruitment information / eligibility

• Status: Completed
• Enrollment: 598682
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Intracranial Thrombosis
• Pulmonary Embolism
• Sinus Thrombosis, Intracranial
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Boston Collaborative Drug Surveillance Program

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence Rate of Idiopathic Venous Thromboembolism (VTE)	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.	Index date (date of VTE diagnosis for case and corresponding date for matched control)	No
Primary	Number of Idiopathic Venous Thromboembolism (VTE) Cases and Matched Controls	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.	Index date (date of VTE diagnosis for case and corresponding date for matched control)	No

External Links

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