Combined Oral Contraceptives Containing Ethinyl Estradiol and Levonorgestrel and Venous Thromboembolism

Basic Details
Date Posted
Saturday, March 3, 2018
Status
Complete
Medical Product
combined oral contraceptive (COC)
Health Outcome(s)
venous thromboembolism (VTE)
Description

This report contains estimates of the risk of venous thromboembolism (VTE) among new users of combined oral contraceptives (COCs) containing ethinyl estradiol and levonorgestrel. Data from May 22, 2007 to September 30, 2015 from 16 health plans contributing to the Sentinel Distributed Database (SDD) were included in this report. This request was distributed on June 24, 2016. 

Additional Details
FDA Center
CDER
Time Period
2007-2015
Study Type
Modular Program
Assessment Type
Safety Analyses
Population / Cohort
Females 18 to 50 years of age
Data Sources
Sentinel Distributed Database (SDD)