Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331071
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2006-05-26
Brief Title:
Postmarketing Study of ORTHO EVRA Norelgestromin and Ethinyl Estradiol Contraceptive Patch in Relation to Venous Thromboembolism Blood Clots Stroke and Heart Attacks
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Postmarketing Study of ORTHO EVRA in Relation to 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:
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 US 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 075 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 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BCDSP-01 | None | None | None |