NCT00377988

Brief Summary

The purpose of the study is to use data from a health care information database to assess the risk of venous thromboembolism (blood clots), myocardial infarction (heart attacks), and stroke among women using a transdermal contraceptive system (ORTHO EVRA) for birth control compared with women using norgestimate-containing oral contraceptives with 35 mcg ethinyl estradiol.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
423

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2002

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

6.5 years

First QC Date

September 15, 2006

Last Update Submit

July 15, 2016

Conditions

ContraceptionFemale Contraception

Keywords

ContraceptionHormonal contraceptionOral contraceptionEthinyl estradiolProgestinTransdermalThrombosisVenous thromboembolism

Outcome Measures

Primary Outcomes (1)

  • AMI and ischemic stroke combined in current and recent users or ORTHO EVRA compared to current and recent users of NGM-OCs with 34 mcg of EE.

    From 01 April 2002 to 31 December 2004 combined with data from the extension period from 01 January 2005 to 31 December 2006.

Secondary Outcomes (5)

  • AMI in current and recent users or ORTHO EVRA compared to current and recent users of NGM-OCs with 34 mcg of EE.

    From 01 April 2002 to 31 December 2006.

  • Ischemic stroke in current and recent users or ORTHO EVRA compared to current and recent users of NGM-OCs with 34 mcg of EE.

    From 01 April 2002 to 31 December 2006.

  • VTE (a combined outcome of PE and DVT) in current and recent users or ORTHO EVRA compared to current and recent users of NGM-OCs with 34 mcg of EE.

    From 01 April 2002 to 31 December 2006.

  • AMI or ischemic stroke or VTE combined in current and recent users or ORTHO EVRA compared to current and recent users of NGM-OCs with 34 mcg of EE.

    From 01 April 2002 to 31 December 2006.

  • All deaths (identified by the NDI), NDI-identified deaths due to AMI, ischemic stroke or VTE, and NDI-identified deaths due to sudden or unknown causes

    From 01 April 2002 to 31 December 2006.

Study Arms (2)

001

Transdermal Contraceptive System In each 4-week period exposed subjects will wear a transdermal patch containing 6 mg norelgestromin and 0.75 mg EE worn for each of 3 consecutive weeks with no patch the 4th week.

Drug: Transdermal Contraceptive System

002

Norgestimate-containing oral contraceptives with EE NGM-OCs with 34 mcg of EE taken during each 4 week period for 21 consecutive days then no pill or a drug-free pill 7 days.

Drug: Norgestimate-containing oral contraceptives with EE

Interventions

Transdermal Contraceptive SystemDRUG

In each 4-week period, exposed subjects will wear a transdermal patch containing 6 mg norelgestromin and 0.75 mg EE worn for each of 3 consecutive weeks with no patch the 4th week.

001
Norgestimate-containing oral contraceptives with EEDRUG

NGM-OCs with 34 mcg of EE taken during each 4 week period for 21 consecutive days, then no pill or a drug-free pill 7 days.

002

Eligibility Criteria

Age15 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women using a transdermal contraceptive system or NGM-OCs containing 35 mcg EE between April 1, 2002 and December 31, 2006 whose medical records are accessable through research databases in the United States.

You may qualify if:

  • Users of a transdermal contraceptive system or norgestimate-containing oral contraceptives with 35 mcg ethinyl estradiol between April 1, 2002 and December 31, 2006, who are identified in the Ingenix Research Database
  • Have complete medical coverage and pharmacy benefits

You may not qualify if:

  • Have a claim associated with physician services for any of the following: malignancy other than non-melanoma skin cancer
  • coagulation defects, history of venous thrombus/embolism, or long-term anticoagulant use
  • Chronic inflammatory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cole JA, Norman H, Doherty M, Walker AM. Venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive system users. Obstet Gynecol. 2007 Feb;109(2 Pt 1):339-46. doi: 10.1097/01.AOG.0000250968.82370.04.

    PMID: 17267834RESULT

Related Links

MeSH Terms

Conditions

ThrombosisVenous Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesThromboembolism

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

September 15, 2006

First Posted

September 19, 2006

Study Start

April 1, 2002

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

July 19, 2016

Record last verified: 2016-07