Actively Recruiting
International Active Surveillance Study: Safety of Estrogen Estetrol (E4) Contraceptive Study (INAS-SEECS)
Led by Center for Epidemiology and Health Research, Germany · Updated on 2025-08-20
68100
Participants Needed
1
Research Sites
214 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
The combined oral contraceptive (COC) containing estetrol (E4) and drospirenone (DRSP) (E4/DRSP) is a novel oral contraceptive containing a fixed dose of E4 (14.2 mg) and DRSP (3 mg). The proposed study will address post-market requirements for E4/DRSP under section 505(o) in response to the Food and Drug Administration (FDA) request. The primary objective of the study is to characterize and compare the risks of E4/DRSP with EE/DRSP and E4/DRSP with a pooled cohort of users of EE/LNG, EE/NETA, and EE/NGM combinations (non-DRSP-containing COCs) in a study population of actual users of these preparations under routine clinical practice. The main clinical outcome of interest is VTE.
CONDITIONS
Official Title
International Active Surveillance Study: Safety of Estrogen Estetrol (E4) Contraceptive Study (INAS-SEECS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- New users of E4/DRSP or EE/DRSP or EE/LNG or EE/NGM or EE/NETA
You will not qualify if you...
- Women who have given birth six weeks before treatment starts will be excluded from the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
3
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