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

Condition(s) targeted: Female Contraception; Contraception

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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, which is a medical claims database.

Official title: Postmarketing Study of ORTHO EVRA in Relation to Venous Thromboembolism, Ischemic Stroke, and Myocardial Infarction

Study design: Natural History, Longitudinal, Case Control, Retrospective Study

Detailed description: ORTHO EVRA is a newly developed transdermal contraceptive system (a "patch") available in the U. S. since April 2002. The study uses data from the PHARMetrics database to assess the occurrence of venous thromboembolism, ischemic stroke, and acute myocardial infarction in current users of ORTHO EVRA compared to current users of norgestimate-containing oral contraceptives with 35 mcg ethinyl estradiol. The PHARMetrics database is an ongoing longitudinal database with information on about 17 million people; it is made up of data contributed by managed care plans in the United States and contains information on paid claims for pharmaceuticals, medical diagnoses and procedures, and demographic information. There will be 3 sets of cases reflecting women who have a first-time recorded claim for an ICD-9 diagnosis during the study period (a) venous thrombosis or pulmonary embolism with hospitalization during the study period and who had subsequent claims for anticoagulant treatment, (b) ischemic stroke and who were hospitalized, (c) acute myocardial infarction or acute coronary revascularization and who were hospitalized. Three separate sets of controls will be identified for each outcome. One analysis will estimate the relative risk of idiopathic ischemic stroke or myocardial infarction, and another analysis will estimate the relative risk of idiopathic venous thromboembolism (deep vein thrombosis or pulmonary embolism). Conditional logistic regression will be used. Analyses will be stratified by calendar year. The analyses will be repeated including non-idiopathic cases of venous thromboembolism, stroke, and heart attacks.

A transdermal patch containing 6 mg NGM and 0. 75 mg EE is worn for 1 week and replaced for 3 consecutive weeks; the fourth week is patch-free. Monophasic or triphasic oral contraceptive pill is taken for 21 consecutive days followed by no pill or a drug-free pill for 7 days.

Minimum age: 15 Years. Maximum age: 44 Years. Gender(s): Female.

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 their health plan prior to the event date of their matched

case

- Start of study contraceptive use after January 1, 2002

Exclusion Criteria:

- Patients with any code for cancer (except for non-melanoma skin cancer), renal

failure, or chronic inflammatory disease

Starting date: April 2002
Last updated: July 27, 2007