Safety study comparing two types of hormonal contraceptives

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 multinational, observational study aims to compare the safety profiles of a new oral contraceptive containing estetrol (E4) and drospirenone (DRSP) against traditional combined oral contraceptives containing ethinyl estradiol (EE) and levonorgestrel (LNG). It will follow two cohorts of new users of these contraceptives over one to two years, focusing on the incidence of venous thromboembolism (VTE) and other related outcomes. The study will utilize a non-interventional approach, gathering data through healthcare professionals and direct participant contact to ensure comprehensive and accurate reporting of outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

New users of E4/DRSP New users of EE/LNG Germany: only recruitment of study participants who are prescribed the COC within on-label use

Exclusion Criteria:

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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.