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

NCT06028555 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 101000

Last updated 2025-08-17

No results posted yet for this study

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.

Conditions

  • Contraception
  • Birth Control

Sponsors & Collaborators

  • Estetra

    collaborator INDUSTRY

  • Gedeon Richter Plc.

    collaborator INDUSTRY

  • Center for Epidemiology and Health Research, Germany

    lead OTHER

Principal Investigators

  • Klaas Heinemann, Dr. · ZEG Berlin GmbH

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-28
Primary Completion
2028-10-31
Completion
2028-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06028555 on ClinicalTrials.gov