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

Group/Cohort | Intervention/treatment |
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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.
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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.
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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. |
- 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. ]
- 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. ]
- 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. ]
- 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. ]
- 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. ]
- 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. ]

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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 |
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

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
Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Publications of Results:
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 |
Contraception Hormonal contraception Oral contraception Ethinyl estradiol |
Progestin Transdermal Thrombosis Venous thromboembolism |
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 |