Status:
COMPLETED
Postmarketing Study of ORTHO EVRA (Norelgestromin and Ethinyl Estradiol Contraceptive Patch) in Relation to Venous Thromboembolism (Blood Clots), Stroke and Heart Attacks
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Boston Collaborative Drug Surveillance Program
Conditions:
Contraception
Female Contraception
Eligibility:
FEMALE
15-44 years
Brief Summary
The purpose of the study is to assess the occurrence of venous thromboembolism (blood clots), stroke, and heart attack in current users of ORTHO EVRA compared to current users of norgestimate-containi...
Detailed Description
ORTHO EVRA is a newly developed transdermal (absorbed through the skin) contraceptive (birth control) system (a "patch") available in the U.S. since April 2002. The study uses data from the PHARMetric...
Eligibility Criteria
Inclusion
- Users of Ortho Evra or first time users of norgestimate-containing oral contraceptives with 35 mcg ethinyl estradiol between April 1, 2002 and December 31, 2004, who are identified in the PHARMetrics database using the National Drug Code (NDC) assigned by the FDA and modified by Pharmetrics
- 6 months of enrollment in a health plan prior to the event date of their matched case
- Start of study contraceptive use after January 1, 2002
- Updates to the original study included users of Ortho Evra or first time users of norgestimate-containing oral contraceptives identified in the PHARMetrics database and a US healthcare claims database through August 2006 and October 2007
Exclusion
- Patients with any ICD-9 code for cancer (except for non-melanoma skin cancer), renal failure, or chronic inflammatory disease
Key Trial Info
Start Date :
April 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT00331071
Start Date
April 1 2002
End Date
March 1 2006
Last Update
July 19 2016
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