A Postmarketing Study of the Risk of Venous Thromboembolism (Blood Clots), Myocardial Infarction (Heart Attacks), and Stroke Among Women Using ORTHO EVRA (Norelgestromin and Ethinyl Estradiol Contraceptive Patch) Compared With Women Who Take Oral Contraceptives for Birth Control
Condition: Contraception; Female Contraception
MeSH terms: Myocardial Infarction; Thromboembolism; Venous Thromboembolism; Infarction
Study type: Observational

Summary: 
      The purpose of the study is to use data from a health care information database to assess the
      risk of venous thromboembolism (blood clots), myocardial infarction (heart attacks), and
      stroke among women using a transdermal contraceptive system (ORTHO EVRA) for birth control
      compared with women using norgestimate-containing oral contraceptives with 35 mcg ethinyl
      estradiol.
    

Detailed description: 
      ORTHO EVRA (norelgestromin and ethinyl estradiol) is a once-a-week transdermal contraceptive
      (birth control) system where a small square-shaped patch is worn on the body and hormones
      from the patch are absorbed transdermally (through the skin) to help prevent pregnancy. This
      is an observational case-control study that will use data provided by a United States health
      care claims database and the National Death Index (NDI) to assess the risk of venous
      thromboembolism abbreviated as VTE (includes deep vein thrombosis abbreviated as DVT [a blood
      clot that forms in one or more of the deep veins of the body, usually the legs] and pulmonary
      embolism abbreviated as PE [a blood clot in the lungs]), acute myocardial infarction
      abbreviated as AMI (heart attack), and ischemic stroke (blockage of an artery that supplies
      blood to the brain) among women using the transdermal contraceptive system, ORTHO EVRA
      compared with women using norgestimate-containing oral contraceptives (NGM-OCs) with 35 mcg
      ethinyl estradiol (EE), during the period 01 April 2002 to 31 December 2004 and during an
      extension period from 01 January 2005 to 31 December 2006. In the extension period of the
      study (01 January 2005 to 31 December 2006), mortality was added as an endpoint in the study.
      After obtaining Institutional Review Board (IRB) approval and a waiver of authorization,
      requests will be made for medical records for all women who have been dispensed at least once
      with ORTHO EVRA or a NGM-OC and whose health insurance claims are consistent with the
      occurrence of VTE, AMI, or stroke. The primary outcome measure in the study is AMI and
      ischemic stroke combined in current and recent users or ORTHO EVRA compared to current and
      recent users of NGM-OCs with 34 mcg of EE. Observational study - No investigational drug
      administered. NOTE: The study was conducted in two parts. Study CR014383, NCT00511784,
      represents the first portion of the study. This study, CR012022, represents the second
      portion of the extended study.
    

Intervention name(s): Transdermal Contraceptive System; Norgestimate-containing oral contraceptives with EE
Intervention type(s): Drug; Drug
Intervention description(s): In each 4-week period, exposed subjects will wear a transdermal patch containing 6 mg norelgestromin and 0.75 mg EE worn for each of 3 consecutive weeks with no patch the 4th week.; NGM-OCs with 34 mcg of EE taken during each 4 week period for 21 consecutive days, then no pill or a drug-free pill 7 days.
Intervention MeSH terms: Contraceptive Agents; Norgestimate; Contraceptives, Oral
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women using a transdermal contraceptive system or NGM-OCs containing 35 mcg EE between
        April 1, 2002 and December 31, 2006 whose medical records are accessable through research
        databases in the United States.
      
Keywords: Contraception; Hormonal contraception; Oral contraception; Ethinyl estradiol; Progestin; Transdermal; Thrombosis; Venous thromboembolism