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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00377988
First received: September 15, 2006
Last updated: May 18, 2011
Last verified: June 2010

September 15, 2006
May 18, 2011
April 2002
Not Provided
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. [ Time Frame: From 01 April 2002 to 31 December 2004 combined with data from the extension period from 01 January 2005 to 31 December 2006. ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00377988 on ClinicalTrials.gov Archive Site
  • AMI in current and recent users or ORTHO EVRA compared to current and recent users of NGM-OCs with 34 mcg of EE. [ Time Frame: From 01 April 2002 to 31 December 2006. ] [ Designated as safety issue: No ]
  • Ischemic stroke in current and recent users or ORTHO EVRA compared to current and recent users of NGM-OCs with 34 mcg of EE. [ Time Frame: From 01 April 2002 to 31 December 2006. ] [ Designated as safety issue: No ]
  • VTE (a combined outcome of PE and DVT) in current and recent users or ORTHO EVRA compared to current and recent users of NGM-OCs with 34 mcg of EE. [ Time Frame: From 01 April 2002 to 31 December 2006. ] [ Designated as safety issue: No ]
  • AMI or ischemic stroke or VTE combined in current and recent users or ORTHO EVRA compared to current and recent users of NGM-OCs with 34 mcg of EE. [ Time Frame: From 01 April 2002 to 31 December 2006. ] [ Designated as safety issue: No ]
  • All deaths (identified by the NDI), NDI-identified deaths due to AMI, ischemic stroke or VTE, and NDI-identified deaths due to sudden or unknown causes [ Time Frame: From 01 April 2002 to 31 December 2006. ] [ Designated as safety issue: No ]
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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
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

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
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Non-Probability Sample

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.

  • Contraception
  • Female Contraception
  • Drug: Transdermal Contraceptive System
    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.
  • Drug: Norgestimate-containing oral contraceptives with EE
    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.
  • 001
    Transdermal Contraceptive System 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.
    Intervention: Drug: Transdermal Contraceptive System
  • 002
    Norgestimate-containing oral contraceptives with EE 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: Drug: Norgestimate-containing oral contraceptives with EE
Cole JA, Norman H, Doherty M, Walker AM. Venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive system users. Obstet Gynecol. 2007 Feb;109(2 Pt 1):339-46. Erratum in: Obstet Gynecol. 2008 Jun;111(6):1449.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
423
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Inclusion Criteria:

  • Users of a transdermal contraceptive system or norgestimate-containing oral contraceptives with 35 mcg ethinyl estradiol between April 1, 2002 and December 31, 2006, who are identified in the Ingenix Research Database
  • Have complete medical coverage and pharmacy benefits

Exclusion Criteria:

  • Have a claim associated with physician services for any of the following: malignancy other than non-melanoma skin cancer
  • coagulation defects, history of venous thrombus/embolism, or long-term anticoagulant use
  • Chronic inflammatory disease
Female
15 Years to 44 Years
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00377988
CR012022, EVRA-13-MAGNIFI
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VP, ESTABLISHED PRODUCTS, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Not Provided
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP