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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00377988 |
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Date of registration:
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15/09/2006 |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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April 2002 |
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Target sample size:
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423 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00377988 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Retrospective
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Contacts
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Name:
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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Key inclusion & exclusion criteria
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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
Age minimum:
15 Years
Age maximum:
44 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Contraception
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Female Contraception
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Intervention(s)
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Drug: Norgestimate-containing oral contraceptives with EE
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Drug: Transdermal Contraceptive System
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Primary Outcome(s)
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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.]
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Secondary Outcome(s)
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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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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.]
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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.]
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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.]
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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.]
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Secondary ID(s)
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CR012022
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EVRA-13-MAGNIFI
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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