A retrospective longitudinal cohort study assessing the safety of Seasonique® use: A post-marketing authorization safety study (PASS) to assess the risk of venous thromboembolic events (VTE) in women exposed to Seasonique®

Study identification

• EU PAS number:
  EUPAS18976
• Study ID:
  33612
• Official title and acronym:
  A retrospective longitudinal cohort study assessing the safety of Seasonique® use: A post-marketing authorization safety study (PASS) to assess the risk of venous thromboembolic events (VTE) in women exposed to Seasonique®
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is an observational retrospective cohort study to assess the safety of Seasonique® use during standard clinical practice. The study participants will consist of females using Seasonique® during the study period. The study population will be identified from an existing US health care database.
• Study status:
  Finalised

Research institutions and networks

Institutions

Optum

Germany

Study timelines

Date when funding contract was signed

Planned: 21/04/2017

Actual: 21/04/2017

Study start date

Planned: 09/05/2017

Actual: 09/05/2017

Date of final study report

Planned: 09/11/2019

Actual: 23/09/2019

Sources of funding

Pharmaceutical company and other private sector 

Non-for-profit organisation (e.g. charity)

More details on funding

Teva Pharmaceutical LTD, Theramex Ireland Limited

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)