NCT06028555 International Active Surveillance Study: Native Estrogen Estetrol (E4) Safety Study
| NCT ID | NCT06028555 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Center for Epidemiology and Health Research, Germany |
| Condition | Contraception |
| Study Type | OBSERVATIONAL |
| Enrollment | 101,000 participants |
| Start Date | 2023-06-28 |
| Primary Completion | 2028-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 101,000 participants in total. It began in 2023-06-28 with a primary completion date of 2028-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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: \-
Contact & Investigator
Klaas Heinemann, Dr.
PRINCIPAL INVESTIGATOR
ZEG Berlin GmbH
Frequently Asked Questions
Who can join the NCT06028555 clinical trial?
This trial is open to female participants only, studying Contraception. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06028555 currently recruiting?
Yes, NCT06028555 is actively recruiting participants. Contact the research team at a.papkalla@zeg-berlin.de for enrollment information.
Where is the NCT06028555 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT06028555 clinical trial?
NCT06028555 is sponsored by Center for Epidemiology and Health Research, Germany. The principal investigator is Klaas Heinemann, Dr. at ZEG Berlin GmbH. The trial plans to enroll 101,000 participants.