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
  Purpose

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.


Condition Intervention
Contraception
Female Contraception
Drug: Transdermal Contraceptive System
Drug: Norgestimate-containing oral contraceptives with EE

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 423
Study Start Date: April 2002
Groups/Cohorts Assigned Interventions
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.
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.
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.
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.

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.

  Eligibility

Ages Eligible for Study:   15 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377988

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
Publications:
Responsible Party: VP, ESTABLISHED PRODUCTS, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00377988     History of Changes
Other Study ID Numbers: CR012022, EVRA-13-MAGNIFI
Study First Received: September 15, 2006
Last Updated: May 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Contraception
Hormonal contraception
Oral contraception
Ethinyl estradiol
Progestin
Transdermal
Thrombosis
Venous thromboembolism

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Thrombosis
Vascular Diseases
Contraceptive Agents
Contraceptives, Oral
Estradiol
Ethinyl Estradiol
Norelgestromin
Norgestimate
Ortho Evra
Contraceptive Agents, Female
Contraceptives, Oral, Combined
Contraceptives, Oral, Synthetic
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents

ClinicalTrials.gov processed this record on October 21, 2014