Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00377988
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2006-09-15
Brief Title:
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
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
The Risk of Venous Thromboembolism Myocardial Infarction and Ischemic Stroke Among Women Using the Transdermal Contraceptive System Compared With Women Using Norgestimate-containing Oral Contraceptives With 35 mcg Ethinyl Estradiol
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 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
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 |
|---|---|---|---|
| EVRA-13-MAGNIFI | None | None | None |