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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Multinational, comparative, prospective, active surveillance study that follows two cohorts. The primary objective of the study is to characterize and compare the risks of E4/Drospirenone (DRSP) with levonorgestrel-containing combined oral contraceptives (EE/LNG) in a study population that is representative of the actual users of these preparations. The main clinical outcome of interest is venous thromboembolism (VTE), specifically deep venous thrombosis (DVT) and pulmonary embolism (PE). Secondary objectives include measuring the occurrence of unintended pregnancy, assessing the risk of arterial thromboembolism (ATE), describing the drug utilization pattern, describing the baseline risk profile for VTE and ATE, and investigating outcomes associated with foetal exposure to E4/DRSP.

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Germany
Berlin Center for Epidemiology and Health Research
RECRUITING
Berlin
Contact Information
Primary
Armin Papkalla, Dr.
a.papkalla@zeg-berlin.de
+49 30 945 101 20
Backup
Silke Zimmermann, Dr.
s.zimmermann@zeg-berlin.de
+49 30 945 101 20
Time Frame
Start Date: 2023-06-28
Estimated Completion Date: 2028-10-31
Participants
Target number of participants: 101000
Treatments
Estetrol/drospirenone (E4/DRSP)
Users: Starters and re-starters
Ethinyl estradiol/levonorgestrel (EE/LNG)
Users: Starters and re-starters
Sponsors
Collaborators: Estetra, Gedeon Richter Plc.
Leads: Center for Epidemiology and Health Research, Germany

This content was sourced from clinicaltrials.gov