NCT06186271 International Active Surveillance Study: Safety of Estrogen Estetrol (E4) Contraceptive Study (INAS-SEECS)
| NCT ID | NCT06186271 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Center for Epidemiology and Health Research, Germany |
| Condition | Contraception |
| Study Type | OBSERVATIONAL |
| Enrollment | 68,100 participants |
| Start Date | 2025-04-24 |
| Primary Completion | 2028-12 |
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 68,100 participants in total. It began in 2025-04-24 with a primary completion date of 2028-12.
⚠ 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
The combined oral contraceptive (COC) containing estetrol (E4) and drospirenone (DRSP) (E4/DRSP) is a novel oral contraceptive containing a fixed dose of E4 (14.2 mg) and DRSP (3 mg). The proposed study will address post-market requirements for E4/DRSP under section 505(o) in response to the Food and Drug Administration (FDA) request. The primary objective of the study is to characterize and compare the risks of E4/DRSP with EE/DRSP and E4/DRSP with a pooled cohort of users of EE/LNG, EE/NETA, and EE/NGM combinations (non-DRSP-containing COCs) in a study population of actual users of these preparations under routine clinical practice. The main clinical outcome of interest is VTE.
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.
Contact & Investigator
Klaas Heinemann, Dr.
PRINCIPAL INVESTIGATOR
ZEG Berlin GmbH
Frequently Asked Questions
Who can join the NCT06186271 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 NCT06186271 currently recruiting?
Yes, NCT06186271 is actively recruiting participants. Contact the research team at a.papkalla@zeg-berlin.de for enrollment information.
Where is the NCT06186271 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT06186271 clinical trial?
NCT06186271 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 68,100 participants.