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.
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Female Contraception; Contraception; Fertility Control
Phase: Phase 4
Status: Completed
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.
Summary
This study uses the PharMetrics 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.
Clinical Details
Official title: Postmarketing Study of ORTHO EVRA and Levonorgestrel Oral Contraceptives in Relation to Non-Fatal Venous Thromboembolism, Ischemic Stroke and Myocardial Infarction.
Study design: Time Perspective: Retrospective
Detailed description:
This observational, retrospective study uses the PharMetrics insurance claims 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.
Eligibility
Minimum age: 15 Years.
Maximum age: 44 Years.
Gender(s): Female.
Criteria:
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 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
Locations and Contacts
Additional Information
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.
Starting date: November 2006
Last updated: October 11, 2007
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