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.

This study has been completed.
Sponsor:
Collaborator:
Boston Collaborative Drug Surveillance Program
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00511784
First received: August 2, 2007
Last updated: October 11, 2007
Last verified: October 2007
  Purpose

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.


Condition Phase
Female Contraception
Contraception
Fertility Control
Phase 4

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Postmarketing Study of ORTHO EVRA and Levonorgestrel Oral Contraceptives in Relation to Non-Fatal Venous Thromboembolism, Ischemic Stroke and Myocardial Infarction.

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Study Start Date: November 2006
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

Ages Eligible for Study:   15 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511784

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Boston Collaborative Drug Surveillance Program
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00511784     History of Changes
Other Study ID Numbers: CR014383
Study First Received: August 2, 2007
Last Updated: October 11, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Transdermal
Venous thromboembolism
Ethinyl estradiol, Levonorgestrel, Contraception
Oral contraception
Hormonal contraception
Contraception
Norelgestromin

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis
Thrombosis
Contraceptive Agents
Levonorgestrel
Norelgestromin
Ortho Evra
Norgestrel
Contraceptives, Oral
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on August 26, 2014