Safety of estetrol (E4) combined with drospirenone (DRSP) birth control

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an international observational post‑marketing safety study comparing new users of the estetrol/drospirenone (E4/DRSP) oral contraceptive with new users of EE/DRSP and with a pooled cohort of EE/LNG, EE/NETA, and EE/NGM users. The main clinical outcomes are venous thromboembolism (VTE) and arterial thromboembolism (ATE), measured in routine clinical practice across participating sites. The study enrolls new users, includes an adequate number of obese women for subgroup analyses, and is sized to rule out a two‑fold increase in VTE risk for the primary comparisons. It is being conducted to meet FDA post‑market requirements and is coordinated by the Center for Epidemiology and Health Research in Germany.

Why it matters

Who can join: the full rules

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.

Where it's running

• Berlin Center for Epidemiology and Health Research
  Berlin, State of Berlin, Germany Recruiting

Study contacts

• Principal investigator: Klaas Heinemann, Dr. — ZEG Berlin GmbH
• Study coordinator: Armin Papkalla, Dr.
• Email: a.papkalla@zeg-berlin.de
• Phone: +49 30 945 101 20

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.