International Active Surveillance Study: Native Estrogen Estetrol (E4) Safety Study

Recruiting now

Conditions studied: Contraception, Birth Control

In brief

Multinational, comparative, prospective, active surveillance study that follows two cohorts. The primary objective of the study is to characterize and compare the risks of E4/Drospirenone (DRSP) with levonorgestrel-containing combined oral contraceptives (EE/LNG) in a study population that is representative of the actual users of these preparations. The main clinical outcome of interest is venous thromboembolism (VTE), specifically deep venous thrombosis (DVT) and pulmonary embolism (PE). Secondary objectives include measuring the occurrence of unintended pregnancy, assessing the risk of arterial thromboembolism (ATE), describing the drug utilization pattern, describing the baseline risk profile for VTE and ATE, and investigating outcomes associated with foetal exposure to E4/DRSP.

Key facts

Study ID

NCT06028555

Run by

Center for Epidemiology and Health Research, Germany

People needed

101000

Starts

2023-06-28

Expected to finish

2028-10-31

Last updated by the study team

2025-08-17

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• New users of E4/DRSP New users of EE/LNG Germany: only recruitment of study participants who are prescribed the COC within on-label use

Where it is running

• Berlin Center for Epidemiology and Health Research — Berlin, State of Berlin, Germany (enrolling)

Full record on ClinicalTrials.gov

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