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Trial record 1 of 1 for:    NCT01297348
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Study Of Lybrel In Relation To Venous Thromboembolism

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ClinicalTrials.gov Identifier: NCT01297348
Recruitment Status : Completed
First Posted : February 16, 2011
Results First Posted : May 27, 2013
Last Update Posted : July 17, 2013
Sponsor:
Collaborator:
Boston Collaborative Drug Surveillance Program
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date February 14, 2011
First Posted Date February 16, 2011
Results First Submitted Date April 2, 2013
Results First Posted Date May 27, 2013
Last Update Posted Date July 17, 2013
Study Start Date July 2007
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 27, 2013)
  • Incidence Rate of Idiopathic Venous Thromboembolism (VTE) [ Time Frame: Index date (date of VTE diagnosis for case and corresponding date for matched control) ]
    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) ]
    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.
Original Primary Outcome Measures
 (submitted: February 14, 2011)
  • deep vein thrombosis (DVT) [ Time Frame: 2007-2012 ]
  • pulmonary embolism (PE) [ Time Frame: 2007-2012 ]
  • cerebral venous sinus thrombosis (CVST) [ Time Frame: 2007-2012 ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study Of Lybrel In Relation To Venous Thromboembolism
Official Title Postmarketing Study Of Lybrel In Relation To Venous Thromboembolism
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Venous Thrombosis
  • Pulmonary Embolism
  • Sinus Thrombosis, Intracranial
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.
    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
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 25, 2012)
598682
Original Estimated Enrollment
 (submitted: February 14, 2011)
250000
Actual Study Completion Date April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 15 Years to 49 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01297348
Other Study ID Numbers 0858A2-4406
B3121004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Boston Collaborative Drug Surveillance Program
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2013