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

NCT00331071 | Completed

• 2 other identifiers: CR012025BCDSP-01
• Study Type: observational
• Target: 334
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Contraception; Female Contraception

Keywords

Contraception; Hormonal contraception; Oral contraception; Ethinyl estradiol, Progestin, Contraception; Transdermal

Outcome Measures

Primary Outcomes (1)

• First-time recorded claim for a) venous thrombosis or pulmonary embolism with hospitalization and claims for anticoagulant treatment, b) ischemic stroke/hospitalized, c) acute myocardial infarction or acute coronary revascularization/hospitalized

  Throughout the study period

Study Arms (2)

001

Ortho Evra transdermal patch containing 6 mg NGMN/0.75 mg EE worn for 1 week and replaced for 3 consecutive weeks fourth week is patch free

Drug: Ortho Evra transdermal patch containing 6 mg NGMN/0.75 mg EE

002

Monophasic or triphasic Oral contraceptive tablet 35 mcg EE for 21 consecutive days followed by no or drug-free tablet for 7 days

Drug: Monophasic or triphasic Oral contraceptive tablet

Interventions

Monophasic or triphasic Oral contraceptive tablet DRUG

fourth week is patch free

002

Ortho Evra transdermal patch containing 6 mg NGMN/0.75 mg EE DRUG

worn for 1 week and replaced for 3 consecutive weeks

001

Eligibility Criteria

• Age: 15 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Data collected from PharMetrics, a United States based, ongoing longitudinal database of data contributed by managed care plans that contains information on unpaid claims for pharmaceuticals, medical diagnoses and procedures and from MarketScan database, a US health care claims database.

You may qualify if:

• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Boston Collaborative Drug Surveillance Program: collaborator

Related Publications (1)

• Jick SS, Kaye JA, Russmann S, Jick H. Risk of nonfatal venous thromboembolism in women using a contraceptive transdermal patch and oral contraceptives containing norgestimate and 35 microg of ethinyl estradiol. Contraception. 2006 Mar;73(3):223-8. doi: 10.1016/j.contraception.2006.01.001. Epub 2006 Jan 26.

  PMID: 16472560 RESULT

Related Links

• Postmarketing Study of ORTHO EVRA in Relation to Non-Fatal Venous Thromboembolism and Cerebral Sinus Thrombosis-September 21, 2005
• Postmarketing Study of ORTHO EVRA in Relation to Ischemic Stroke, Acute Myocardial Infarction and Cerebral Sinus Thrombosis-December 15, 2005
• Postmarketing Study of ORTHO EVRA in Relation to Non-Fatal Venous Thromboembolism-January 16, 2007
• Report on the 2007 Update on Post marketing Study of ORTHO EVRA in Relation to Non-Fatal Venous Thromboembolism, Ischemic Stroke, Acute Myocardial Infarction, and Cerebral Vascular Sinus Thrombosis-May 20, 2008

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2006
• First Posted: May 29, 2006
• Study Start: April 1, 2002
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: July 19, 2016

Record last verified: 2016-07