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

NCT00331071 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 334

Last updated 2016-07-19

No results posted yet for this study

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

Interventions

DRUG

Monophasic or triphasic Oral contraceptive tablet

fourth week is patch free

DRUG

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

worn for 1 week and replaced for 3 consecutive weeks

Sponsors & Collaborators

  • Boston Collaborative Drug Surveillance Program

    collaborator OTHER

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

    lead INDUSTRY

Principal Investigators

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

Eligibility

Min Age
15 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-04-30
Primary Completion
2006-03-31
Completion
2006-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00331071 on ClinicalTrials.gov