Venous and Arterial Thromboembolism among New Users of NuvaRing and Other Combined Hormonal Contraceptives: A Descriptive Analysis

Basic Details
Date Posted
Thursday, March 25, 2021
Status
Complete
Medical Product
combined hormonal contraceptives (CHCs)
ethinyl estradiol (EE)
NuvaRing
Health Outcome(s)
arterial thromboembolism (ATE)
venous thromboembolism (VTE)
Description

In this report we examined the characteristics of new users of NuvaRing and other combined hormonal contraceptives (oCHCs) with less than or equal to 20 mcg of ethinyl estradiol (EE) and conducted risk assessment for venous thromboembolism (VTE) and arterial thromboembolism (ATE) in the Sentinel Distributed Database (SDD).

The study period includes data from January 1, 2014 to December 31, 2019. We distributed this request to 15 Data Partners on July 29, 2020.

Additional Details
FDA Center
CDER
Time Period
January 1, 2014 - December 31, 2019
Study Type
Modular Program
Assessment Type
Exploratory Analyses
Population / Cohort
Females 21 years of age and older
Data Sources
Sentinel Distributed Database (SDD)