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Study Of Lybrel In Relation To Venous Thromboembolism

Last updated on October 10, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Venous Thrombosis, Pulmonary Embolism, Intracranial Sinus Thrombosis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
15-49 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- No specific exclusion criteria for the base study cohort.

NCT01297348
Pfizer
Completed
Study Of Lybrel In Relation To Venous Thromboembolism

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Descriptive Information
Brief TitleStudy Of Lybrel In Relation To Venous Thromboembolism
Official TitlePostmarketing Study Of Lybrel In Relation To Venous Thromboembolism
Brief SummaryLybrel® is an oral contraceptive that delivers low doses of levonorgestrel and ethinyl estradiol (90 ?g/20 ?g). 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 20?g of ethinyl estradiol.
Detailed DescriptionThe 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 TypeObservational
Study DesignObservational Model: Case Control
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationThe 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 20?g of ethinyl estradiol
    Current users of oral contraceptives containing 20?g 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 StatusCompleted
Actual Enrollment
 (submitted: July 25, 2012)
598682
Original Estimated Enrollment
 (submitted: February 14, 2011)
250000
Actual Study Completion DateApril 2012
Actual Primary Completion DateApril 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
Ages15 Years to 49 Years   (Child, Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01297348
Other Study ID Numbers0858A2-4406
B3121004
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsBoston Collaborative Drug Surveillance Program
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2013

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