International Active Surveillance Study: Native Estrogen Estetrol (E4) Safety Study

Launched by CENTER FOR EPIDEMIOLOGY AND HEALTH RESEARCH, GERMANY · Aug 31, 2023

Keywords

ClinConnect Summary

The International Active Surveillance Study is a clinical trial designed to compare the safety of two types of birth control pills: one that contains estrogen called Estetrol (E4) combined with Drospirenone (DRSP), and another that contains Levonorgestrel (EE/LNG). The main focus of this study is to see how these medications affect the risk of serious blood clots, specifically deep vein thrombosis (DVT) and pulmonary embolism (PE). The study will also look at other important aspects, like the rates of unintended pregnancies and any possible effects if a baby is exposed to E4/DRSP during pregnancy.

This trial is currently looking for women who are new users of either E4/DRSP or EE/LNG birth control pills. To participate, you should be starting one of these medications as prescribed by your doctor. If you join the study, you can expect regular follow-ups to monitor your health and any side effects you may experience while using these birth control options. This research aims to provide valuable information that can help women choose safer contraceptive methods.

Gender

FEMALE

Eligibility criteria

• 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:
• • -