Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511784
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2007-08-02
Brief Title:
Relative Risks for Non-fatal Venous Thromboembolism Ischemic Stroke and Myocardial Infarction in Users of ORTHO EVRANorelgestromin and Ethinyl Estradiol Contraceptive Patch Compared to Levonorgestrel-containing Oral Contraceptives
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Postmarketing Study of ORTHO EVRA and Levonorgestrel Oral Contraceptives in Relation to Non-fatal Venous Thromboembolism Ischemic Stroke and Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study uses the PharMetrics and MarketScan US health care insurance claims database to estimate relative risks for non-fatal venous thromboembolism including cerebral venous sinus thrombosis ischemic stroke and acute myocardial infarction heart attack in current users of ORTHO EVRA norelgestromin and ethinyl estradiol contraceptive patch compared to current users of oral levonorgestrel-containing oral contraceptives with 30 micrograms ethinyl estradiol with special attention to duration of use
Detailed Description:
This observational retrospective study uses the PharMetrics and MarketScan US health care claim insurance database to assess the occurrence of venous thromboembolism including cerebral venous sinus thrombosis ischemic stroke and acute myocardial infarction in current users of ORTHO EVRA norelgestromin and ethinyl estradiol transdermal contraceptive patch compared to current users of levonorgestrel-containing oral contraceptives with 30 micrograms ethinyl estradiol with special attention to duration of use PharMetrics is a United States based ongoing longitudinal database with information on around 55 million covered lives going back as far as 1995 It is made up of data contributed by managed care plans throughout the United States and it contains information on paid claims for pharmaceuticals medical diagnoses and procedures as well as demographic information on all subjects There will be 3 sets of cases reflecting women who have a first-time recorded claim for an ICD-9 diagnosis of the following during the study period 1 deep vein thrombosis blood clot pulmonary embolism or cerebral venous sinus thrombosis venous thrombotic event VTE with hospitalization a visit to the emergency room or positive indication of VTE from diagnostic test results at any time during the study period and who had subsequent multiple claims for anticoagulant treatment The requirement for multiple prescriptions for anticoagulation therapy was used to provide evidence that the original diagnosis of VTE was confirmed 2 ischemic stroke and who were hospitalized or 3 acute myocardial infarction heart attack or acute coronary revascularization and who were hospitalized Three separate sets of controls will be identified for each outcome Planned analysis will estimate the relative risk of idiopathic unknown cause ischemic stroke or myocardial infarction and another analysis will estimate the relative risk of idiopathic VTE Conditional logistic regression will be used Analyses will be stratified by calendar year The analyses will be repeated including non-idiopathic cases of VTE ischemic stroke and acute myocardial infarction Each transdermal patch containing 6 milligrams norelgestromin and 075 milligram ethinyl estradiol is worn for 1 week for 3 consecutive weeks the fourth week is patch-free Triphasic levonorgestrel-containing oral contraceptives with 30 micrograms ethinyl estradiol is taken for 21 consecutive days followed by no pill or an inert pill for 7 days Duration of use can vary NOTE The study was conducted in two parts This study CR014383 represents the first portion of the study Study CR012022 NCT00377988 represents the second portion of the extended study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None