International Active Surveillance Study: Safety of Estrogen Estetrol (E4) Contraceptive Study (INAS-SEECS)
Launched by CENTER FOR EPIDEMIOLOGY AND HEALTH RESEARCH, GERMANY · Dec 15, 2023
Trial Information
Current as of July 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The International Active Surveillance Study is looking at a new type of birth control pill called estetrol (E4) combined with drospirenone (DRSP). This study aims to understand how safe this new pill is compared to other commonly used birth control pills that contain different hormone combinations. The main concern the study is focusing on is the risk of blood clots, known as venous thromboembolism (VTE), in women taking these pills.
To be eligible for this study, you must be a new user of one of the birth control pills being compared, such as E4/DRSP or other combinations like EE/DRSP. However, women who have had a baby in the last six weeks will not be able to participate. The study is currently not recruiting, which means they haven’t started signing up participants yet. If you join, you'll be part of a group that helps researchers learn more about the safety of these contraceptive options in real-life settings.
Gender
FEMALE
Eligibility criteria
- 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.
About Center For Epidemiology And Health Research, Germany
The Center for Epidemiology and Health Research in Germany is a leading institution dedicated to advancing public health through rigorous epidemiological studies and clinical research. With a focus on understanding the determinants of health and disease, the center conducts innovative trials that aim to inform public health policies and improve health outcomes. Committed to fostering collaboration among researchers, healthcare professionals, and policymakers, the center employs state-of-the-art methodologies to generate evidence-based insights that address pressing health challenges. Through its comprehensive research initiatives, the center plays a pivotal role in enhancing the scientific foundation for health interventions and promoting community well-being.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Klaas Heinemann, Dr.
Principal Investigator
ZEG Berlin GmbH
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported