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International Active Surveillance Study: Native Estrogen Estetrol (E4) Safety Study
Sponsor: Center for Epidemiology and Health Research, Germany
Summary
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 Details
Gender
FEMALE
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
101000
Start Date
2023-06-28
Completion Date
2028-10-31
Last Updated
2025-08-17
Healthy Volunteers
Yes
Conditions
Locations (1)
Berlin Center for Epidemiology and Health Research
Berlin, State of Berlin, Germany