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International Active Surveillance Study: Safety of Estrogen Estetrol (E4) Contraceptive Study (INAS-SEECS)

NCT06186271 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 68100

Last updated 2025-08-20

No results posted yet for this study

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.

Conditions

  • Contraception

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
No

Timeline & Regulatory

Start
2025-04-24
Primary Completion
2028-12-31
Completion
2029-06-30

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 NCT06186271 on ClinicalTrials.gov