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International Active Surveillance Study: Safety of Estrogen Estetrol (E4) Contraceptive Study (INAS-SEECS)

Recruitingn/aAges any - anyFemaleCenter for Epidemiology and Health Research, Germ…
NCT06186271 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: • New users of E4/DRSP or EE/DRSP or EE/LNG or EE/NGM or EE/NETA Exclusion Criteria: • Women who have given birth six weeks before treatment starts will be excluded from the study.
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What it tests

  • Not listed
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Where

1 site
Berlin Center for Epidemiology and Health Research
Berlin, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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