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.
Postmarketing Study of ORTHO EVRA and Levonorgestrel Oral Contraceptives in Relation to Non-fatal Venous Thromboembolism, Ischemic Stroke and Myocardial Infarction.
1 other identifier
observational
440
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2006
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 2, 2007
CompletedFirst Posted
Study publicly available on registry
August 6, 2007
CompletedJuly 19, 2016
July 1, 2016
7 months
August 2, 2007
July 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
6 months
Study Arms (2)
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
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2007
First Posted
August 6, 2007
Study Start
November 1, 2006
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
July 19, 2016
Record last verified: 2016-07