International Active Surveillance Study: Safety of Estrogen Estetrol (E4) Contraceptive Study (INAS-SEECS)
Recruiting now
Conditions studied: Contraception
In brief
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.
Key facts
- Study ID
- NCT06186271
- Run by
- Center for Epidemiology and Health Research, Germany
- People needed
- 68100
- Starts
- 2025-04-24
- Expected to finish
- 2029-06-01
- Last updated by the study team
- 2025-08-20
Who can join
Age: any. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- New users of E4/DRSP or EE/DRSP or EE/LNG or EE/NGM or EE/NETA
You may not qualify if…
- Women who have given birth six weeks before treatment starts will be excluded from the study.
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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