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| Sponsor: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT00377988 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Contraception Female Contraception |
Drug: Transdermal Contraceptive System Drug: Norgestimate-containing oral contraceptives with EE |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Retrospective |
| Official Title: | The Risk of Venous Thromboembolism, Myocardial Infarction, and Ischemic Stroke Among Women Using the Transdermal Contraceptive System Compared With Women Using Norgestimate-containing Oral Contraceptives With 35 Mcg Ethinyl Estradiol |
| Enrollment: | 423 |
| Study Start Date: | April 2002 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
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.
|
|
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
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.
|
ORTHO EVRA (norelgestromin and ethinyl estradiol) is a once-a-week transdermal contraceptive (birth control) system where a small square-shaped patch is worn on the body and hormones from the patch are absorbed transdermally (through the skin) to help prevent pregnancy. This is an observational case-control study that will use data provided by a United States health care claims database and the National Death Index (NDI) to assess the risk of venous thromboembolism abbreviated as VTE (includes deep vein thrombosis abbreviated as DVT [a blood clot that forms in one or more of the deep veins of the body, usually the legs] and pulmonary embolism abbreviated as PE [a blood clot in the lungs]), acute myocardial infarction abbreviated as AMI (heart attack), and ischemic stroke (blockage of an artery that supplies blood to the brain) among women using the transdermal contraceptive system, ORTHO EVRA compared with women using norgestimate-containing oral contraceptives (NGM-OCs) with 35 mcg ethinyl estradiol (EE), during the period 01 April 2002 to 31 December 2004 and during an extension period from 01 January 2005 to 31 December 2006. In the extension period of the study (01 January 2005 to 31 December 2006), mortality was added as an endpoint in the study. After obtaining Institutional Review Board (IRB) approval and a waiver of authorization, requests will be made for medical records for all women who have been dispensed at least once with ORTHO EVRA or a NGM-OC and whose health insurance claims are consistent with the occurrence of VTE, AMI, or stroke. The primary outcome measure in the study is 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. Observational study - No investigational drug administered.
Eligibility| Ages Eligible for Study: | 15 Years to 44 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
| Responsible Party: | VP, ESTABLISHED PRODUCTS, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT00377988 History of Changes |
| Other Study ID Numbers: | CR012022, EVRA-13-MAGNIFI |
| Study First Received: | September 15, 2006 |
| Last Updated: | May 18, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Contraception Hormonal contraception Oral contraception Ethinyl estradiol |
Progestin Transdermal Thrombosis Venous thromboembolism |
|
Infarction Myocardial Infarction Thromboembolism Venous Thromboembolism Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Embolism and Thrombosis Thrombosis Contraceptive Agents Estradiol valerate |
Estradiol 3-benzoate Estradiol 17 beta-cypionate Norgestimate Norelgestromin Contraceptives, Oral Estradiol Polyestradiol phosphate Ethinyl Estradiol Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptive Agents, Female Estrogens Hormones |