Relative Risks for Non-fatal Venous Thromboembolism, Ischemic Stroke and Myocardial Infarction in Users of ORTHO EVRA(Norelgestromin and Ethinyl Estradiol Contraceptive Patch) Compared to Levonorgestrel-containing Oral Contraceptives.

July 15, 2016 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Postmarketing Study of ORTHO EVRA and Levonorgestrel Oral Contraceptives in Relation to Non-fatal Venous Thromboembolism, Ischemic Stroke and Myocardial Infarction.

This study uses the PharMetrics and MarketScan US health care insurance claims database to estimate relative risks for non-fatal venous thromboembolism (including cerebral venous sinus thrombosis), ischemic stroke, and acute myocardial infarction (heart attack), in current users of ORTHO EVRA (norelgestromin and ethinyl estradiol contraceptive patch) compared to current users of oral levonorgestrel-containing oral contraceptives with 30 micrograms ethinyl estradiol, with special attention to duration of use.

Study Overview

Status

Completed

Conditions

Detailed Description

This observational, retrospective study uses the PharMetrics and MarketScan US health care claim insurance database to assess the occurrence of venous thromboembolism (including cerebral venous sinus thrombosis), ischemic stroke, and acute myocardial infarction in current users of ORTHO EVRA (norelgestromin and ethinyl estradiol transdermal contraceptive patch) compared to current users of levonorgestrel-containing oral contraceptives with 30 micrograms ethinyl estradiol, with special attention to duration of use. PharMetrics is a United States based, ongoing longitudinal database with information on around 55 million covered lives going back as far as 1995. It is made up of data contributed by managed care plans throughout the United States and it contains information on paid claims for pharmaceuticals, medical diagnoses and procedures as well as demographic information on all subjects. There will be 3 sets of cases reflecting women who have a first-time recorded claim for an ICD-9 diagnosis of the following during the study period: (1) deep vein thrombosis (blood clot), pulmonary embolism, or cerebral venous sinus thrombosis, venous thrombotic event (VTE) with hospitalization, a visit to the emergency room or positive indication of VTE from diagnostic test results, at any time during the study period and who had subsequent multiple claims for anticoagulant treatment. The requirement for multiple prescriptions for anticoagulation therapy was used to provide evidence that the original diagnosis of VTE was confirmed. (2) ischemic stroke and who were hospitalized, or (3) acute myocardial infarction (heart attack) or acute coronary revascularization and who were hospitalized. Three separate sets of controls will be identified for each outcome. Planned analysis will estimate the relative risk of idiopathic (unknown cause) ischemic stroke or myocardial infarction, and another analysis will estimate the relative risk of idiopathic VTE. Conditional logistic regression will be used. Analyses will be stratified by calendar year. The analyses will be repeated including non-idiopathic cases of VTE, ischemic stroke, and acute myocardial infarction. Each transdermal patch containing 6 milligrams norelgestromin and 0.75 milligram ethinyl estradiol is worn for 1 week for 3 consecutive weeks; the fourth week is patch-free. Triphasic levonorgestrel-containing oral contraceptives with 30 micrograms ethinyl estradiol is taken for 21 consecutive days followed by no pill or an inert pill for 7 days. Duration of use can vary. NOTE: The study was conducted in two parts. This study, CR014383, represents the first portion of the study. Study CR012022, NCT00377988, represents the second portion of the extended study.

Study Type

Observational

Enrollment (Actual)

440

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 44 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

PharmaMetrics and MarketScan US health care claims database identified women 15-44 who were users of ORTHO EVRA or first time users of levonorgestrel-containing oral contraceptive with 30 micrograms ethinyl estradiol between April 1, 2002 and March 31, 2006

Description

Inclusion Criteria:

  • Users of ORTHO EVRA or first time users of levonorgestrel-containing oral contraceptive with 30 micrograms ethinyl estradiol between April 1, 2002 and March 31, 2006, who are identified in the MarketScan and PHARMetrics database using the National Drug Code (NDC) assigned by the FDA and modified by PharMetrics
  • Start of study contraceptive use after April 1, 2002
  • Six (6) months of enrollment in their health plan prior to the event date of their matched case
  • At least four (4) months of history in their claims record before the first recorded study drug dispensing.

Exclusion Criteria:

  • When women received both levonorgestrel-containing oral contraceptive with 30 micrograms ethinyl estradiol and levonorgestrel-containing oral contraceptive with 20 micrograms ethinyl estradiol, this analysis only includes the 30 micrograms ethinyl estradiol preparations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
OrthoEvra(norelgestromin/ethinylestradiol contraceptive patch)
subjects in insurance claims database who used transdermal patch containing 6 milligrams norelgestromin and 0.75 milligram ethinyl estradiol worn for 1 week for 3 consecutive weeks; the fourth week was patch-free
levonorgestrel-containing oral contraceptives
subjects in insurance claims database who were first time users of triphasic levonorgestrel-containing oral contraceptives with 30 micrograms ethinyl estradiol taken for 21 consecutive days followed by no pill or an inert pill for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
estimate risk of non-fatal venous thromboembolism(including cerebral venous sinus thrombosis),ischemic stroke and acute MI in OrthoEvra users compared to users of oral levonorgestrel-containing oral contraceptives with 30mcg ethinyl estradiol
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Collaborators

Boston Collaborative Drug Surveillance Program

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

August 2, 2007

First Submitted That Met QC Criteria

August 2, 2007

First Posted (Estimate)

August 6, 2007

Study Record Updates

Last Update Posted (Estimate)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 15, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR014383

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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