Postmarketing Study of ORTHO EVRA (Norelgestromin and Ethinyl Estradiol Contraceptive Patch) in Relation to Venous Thromboembolism (Blood Clots), Stroke and Heart Attacks

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: Female

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-containing oral contraceptives with 35 mcg ethinyl estradiol with special attention to duration of use. The study uses data from the PharMetrics Patient-Centric Database and MarketScan database, which are US medical claims databases.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Boston Collaborative Drug Surveillance Program
• Treatments: Contraceptive Agents; Contraceptives, Oral; Estradiol; Ethinyl Estradiol; Norelgestromin; Norgestrel; Ortho Evra

Criteria

Inclusion Criteria:

• 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 Criteria:

• Patients with any ICD-9 code for cancer (except for non-melanoma skin cancer), renal failure, or chronic inflammatory disease