Actively Recruiting
International Active Surveillance Study: Native Estrogen Estetrol (E4) Safety Study
Led by Center for Epidemiology and Health Research, Germany · Updated on 2025-08-17
101000
Participants Needed
1
Research Sites
278 weeks
Total Duration
On this page
Sponsors
C
Center for Epidemiology and Health Research, Germany
Lead Sponsor
E
Estetra
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
International Active Surveillance Study: Native Estrogen Estetrol (E4) Safety Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- New users of E4/DRSP
- New users of EE/LNG
- In Germany, only participants prescribed the contraceptive within on-label use are eligible
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Berlin Center for Epidemiology and Health Research
Berlin, State of Berlin, Germany, 10115
Actively Recruiting
Research Team
A
Armin Papkalla, Dr.
CONTACT
S
Silke Zimmermann, Dr.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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