Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Postmarketing Study of ORTHO EVRA (Norelgestromin and Ethinyl Estradiol Contraceptive Patch) in Relation to Venous Thromboembolism (Blood Clots), Stroke and Heart Attacks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00331071
Recruitment Status : Completed
First Posted : May 29, 2006
Last Update Posted : July 19, 2016
Sponsor:
Collaborator:
Boston Collaborative Drug Surveillance Program
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tracking Information
First Submitted Date May 26, 2006
First Posted Date May 29, 2006
Last Update Posted Date July 19, 2016
Study Start Date April 2002
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 3, 2010)
First-time recorded claim for a) venous thrombosis or pulmonary embolism with hospitalization and claims for anticoagulant treatment, b) ischemic stroke/hospitalized, c) acute myocardial infarction or acute coronary revascularization/hospitalized [ Time Frame: Throughout the study period ]
Original Primary Outcome Measures Not Provided
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 Postmarketing Study of ORTHO EVRA (Norelgestromin and Ethinyl Estradiol Contraceptive Patch) in Relation to Venous Thromboembolism (Blood Clots), Stroke and Heart Attacks
Official Title Postmarketing Study of ORTHO EVRA in Relation to Venous Thromboembolism, Ischemic Stroke, and Myocardial Infarction
Brief Summary The purpose of the study is to assess the occurrence of venous thromboembolism (blood clots), stroke, and heart attack in current users of ORTHO EVRA compared to current users of norgestimate-containing oral contraceptives with 35 mcg ethinyl estradiol with special attention to duration of use. The study uses data from the PharMetrics Patient-Centric Database and MarketScan database, which are US medical claims databases.
Detailed Description ORTHO EVRA is a newly developed transdermal (absorbed through the skin) contraceptive (birth control) system (a "patch") available in the U.S. since April 2002. The study uses data from the PHARMetrics and MarketScan databases to assess the occurrence of venous thromboembolism (blood clots), ischemic stroke (blockage of an artery that supplies blood to the brain), and acute myocardial infarction (heart attack) in current first time users of ORTHO EVRA compared to current first time users of norgestimate-containing oral (by mouth) contraceptives with 35 mcg ethinyl estradiol. The PHARMetrics database is an ongoing longitudinal database with information on about 17 million people. It is made up of data contributed by managed care plans in the United States and contains information on paid claims for pharmaceuticals, medical diagnoses and procedures, and demographic (age, race, etc) information. There will be 3 sets of cases reflecting women who have a first-time recorded claim for an ICD-9 (International Classification of Diseases , ninth revision) diagnosis during the study period (a) venous thrombosis or pulmonary embolism (blood clot in the lung) with hospitalization during the study period and who had subsequent claims for anticoagulant treatment, (b) ischemic stroke and who were hospitalized, (c) acute myocardial infarction or acute coronary revascularization (restoration of blood supply to the heart) and who were hospitalized. Three separate sets of controls (patients) will be identified for each outcome. One analysis will estimate the relative risk of idiopathic (of unknown cause) ischemic stroke or myocardial infarction, and another analysis will estimate the relative risk of idiopathic venous thromboembolism (deep vein thrombosis or pulmonary embolism). A specific analysis called a "Conditional logistic regression" (conditional on the matching factors) will be used in this study. Analyses will be stratified by calendar year. The analyses will be repeated including non-idiopathic (ie, of known cause) cases of venous thromboembolism, stroke, and heart attacks. The original study runs through March 2005, with updates to through August 2006, and October 2007. A transdermal patch containing 6 mg norelgestromin (NGM) and 0.75 mg ethinyl estradiol (EE) is worn for 1 week and replaced weekly for 3 consecutive weeks; the fourth week is patch-free. Monophasic (all pills have the same hormones at the same concentration) or triphasic (3 different pills are taken during the cycle) oral contraceptive pill is taken for 21 consecutive days followed by no pill or a drug-free pill for 7 days.
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 Data collected from PharMetrics, a United States based, ongoing longitudinal database of data contributed by managed care plans that contains information on unpaid claims for pharmaceuticals, medical diagnoses and procedures and from MarketScan database, a US health care claims database.
Condition
  • Contraception
  • Female Contraception
Intervention
  • Drug: Monophasic or triphasic Oral contraceptive tablet
    fourth week is patch free
  • Drug: Ortho Evra transdermal patch containing 6 mg NGMN/0.75 mg EE
    worn for 1 week and replaced for 3 consecutive weeks
Study Groups/Cohorts
  • 001
    Ortho Evra transdermal patch containing 6 mg NGMN/0.75 mg EE worn for 1 week and replaced for 3 consecutive weeks fourth week is patch free
    Intervention: Drug: Ortho Evra transdermal patch containing 6 mg NGMN/0.75 mg EE
  • 002
    Monophasic or triphasic Oral contraceptive tablet 35 mcg EE for 21 consecutive days followed by no or drug-free tablet for 7 days
    Intervention: Drug: Monophasic or triphasic Oral contraceptive tablet
Publications * Jick SS, Kaye JA, Russmann S, Jick H. Risk of nonfatal venous thromboembolism in women using a contraceptive transdermal patch and oral contraceptives containing norgestimate and 35 microg of ethinyl estradiol. Contraception. 2006 Mar;73(3):223-8. Epub 2006 Jan 26.

*   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: June 3, 2010)
334
Original Enrollment Not Provided
Actual Study Completion Date March 2006
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Users of Ortho Evra or first time users of norgestimate-containing oral contraceptives with 35 mcg ethinyl estradiol between April 1, 2002 and December 31, 2004, who are identified in the PHARMetrics database using the National Drug Code (NDC) assigned by the FDA and modified by Pharmetrics
  • 6 months of enrollment in a health plan prior to the event date of their matched case
  • Start of study contraceptive use after January 1, 2002
  • Updates to the original study included users of Ortho Evra or first time users of norgestimate-containing oral contraceptives identified in the PHARMetrics database and a US healthcare claims database through August 2006 and October 2007

Exclusion Criteria:

  • Patients with any ICD-9 code for cancer (except for non-melanoma skin cancer), renal failure, or chronic inflammatory disease
Sex/Gender
Sexes Eligible for Study: Female
Ages 15 Years to 44 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00331071
Other Study ID Numbers CR012025
BCDSP-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Sponsor Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators Boston Collaborative Drug Surveillance Program
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PRS Account Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date July 2016