Combined Oral Contraceptives Containing Ethinyl Estradiol and Levonorgestrel and Venous Thromboembolism

Details

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.

Deliverables (1)

Sentinel Modular Program Report: Combined Oral Contraceptives Containing Ethinyl Estradiol and Levonorgestrel and Venous Thromboembolism

Additional Information

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)