Status:
COMPLETED
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
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Contraception
Female Contraception
Eligibility:
FEMALE
15-44 years
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 wome...
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 ar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
423 Patients enrolled
Trial Details
Trial ID
NCT00377988
Start Date
April 1 2002
End Date
October 1 2008
Last Update
July 19 2016
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