Study Of Lybrel In Relation To Venous Thromboembolism
Condition: Venous Thrombosis; Pulmonary Embolism; Sinus Thrombosis, Intracranial
MeSH terms: Pulmonary Embolism; Sinus Thrombosis, Intracranial; Intracranial Thrombosis; Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Study type: Observational

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.
    

Intervention name(s): 90ug levonorgestrel / 20 ug ethinyl estradiol; Oral Contraceptives containing 20 ug of ethinyl estradiol
Intervention type(s): Drug; Drug
Intervention description(s): This is a non-interventional observational database study, thus no interventions are offered to patients in the study.; This is a non-interventional observational database study, thus no interventions are offered to patients in the study.
Other intervention name(s): Lybrel; 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
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Levonorgestrel; Ethinyl Estradiol; Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; Norinyl; Contraceptive Agents; Contraceptives, Oral; Estradiol; Polyestradiol phosphate
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.
      
Keywords: Lybrel; levonorgestrel; ethinyl estradiol; venus thromboembolism (VTE); oral contraceptives (OC); safety; database study; case-control study