NCT00377988View on ClinicalTrials.gov

A Postmarketing Study of the Risk of Venous Thromboembolism (Blood Clots), Myocardial Infarction (Heart Attacks), and Stroke Among Women Using ORTHO EVRA (Norelgestromin and Ethinyl Estradiol Contraceptive Patch) Compared With Women Who Take Oral Contraceptives for Birth Control

CompletedOBSERVATIONAL
Enrollment

423

Participants

Timeline

Start Date

April 30, 2002

Primary Completion Date

October 31, 2008

Study Completion Date

October 31, 2008

Conditions
ContraceptionFemale Contraception
Interventions
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.

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.

All Listed Sponsors
lead

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

INDUSTRY

NCT00377988 - A Postmarketing Study of the Risk of Venous Thromboembolism (Blood Clots), Myocardial Infarction (Heart Attacks), and Stroke Among Women Using ORTHO EVRA (Norelgestromin and Ethinyl Estradiol Contraceptive Patch) Compared With Women Who Take Oral Contraceptives for Birth Control | Biotech Hunter | Biotech Hunter