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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

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ClinicalTrials.gov Identifier: NCT00377988
Recruitment Status : Completed
First Posted : September 19, 2006
Last Update Posted : July 19, 2016
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Description
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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.

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

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 Design
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Study Type : Observational
Actual Enrollment : 423 participants
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
Study Start Date : April 2002
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]
  4. 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. ]
  5. 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. ]

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 44 Years   (Child, Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377988


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

Publications of Results:

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Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00377988    
Other Study ID Numbers: CR012022
EVRA-13-MAGNIFI
First Posted: September 19, 2006    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016
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:
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Myocardial Infarction
Thromboembolism
Venous Thromboembolism
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Embolism and Thrombosis
Contraceptive Agents
Norgestimate
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic