Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study Of Lybrel In Relation To Venous Thromboembolism

This study has been completed.
Sponsor:
Collaborator:
Boston Collaborative Drug Surveillance Program
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01297348
First received: February 14, 2011
Last updated: June 27, 2013
Last verified: June 2013

February 14, 2011
June 27, 2013
July 2007
April 2012   (final data collection date for primary outcome measure)
  • Incidence Rate of Idiopathic Venous Thromboembolism (VTE) [ Time Frame: Index date (date of VTE diagnosis for case and corresponding date for matched control) ] [ Designated as safety issue: No ]
    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.
  • Number of Idiopathic Venous Thromboembolism (VTE) Cases and Matched Controls [ Time Frame: Index date (date of VTE diagnosis for case and corresponding date for matched control) ] [ Designated as safety issue: No ]
    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.
  • deep vein thrombosis (DVT) [ Time Frame: 2007-2012 ] [ Designated as safety issue: Yes ]
  • pulmonary embolism (PE) [ Time Frame: 2007-2012 ] [ Designated as safety issue: Yes ]
  • cerebral venous sinus thrombosis (CVST) [ Time Frame: 2007-2012 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01297348 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study Of Lybrel In Relation To Venous Thromboembolism
Postmarketing Study Of Lybrel In Relation To Venous Thromboembolism

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Venous Thrombosis
  • Pulmonary Embolism
  • Sinus Thrombosis, Intracranial
  • 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.
    Other Name: Lybrel
  • 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.
    Other Name: Lessina, Aviane, Junel 1/20, Junel FE 1/20, Levlite, Lutera, Alesse, Loestrin FE 1/20, Loestrin 1/20, Microgestin 1/20, Microgestin FE 1/20
  • Lybrel®
    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).
    Intervention: Drug: 90ug levonorgestrel / 20 ug ethinyl estradiol
  • Other OCs containing 20μg of ethinyl estradiol
    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)
    Intervention: Drug: Oral Contraceptives containing 20 ug of ethinyl estradiol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
598682
April 2012
April 2012   (final data collection date for primary outcome measure)

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.
Female
15 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01297348
0858A2-4406, B3121004
No
Pfizer
Pfizer
Boston Collaborative Drug Surveillance Program
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP