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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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 | DecenTrialz