Status:
RECRUITING
International Active Surveillance Study: Safety of Estrogen Estetrol (E4) Contraceptive Study (INAS-SEECS)
Lead Sponsor:
Center for Epidemiology and Health Research, Germany
Collaborating Sponsors:
Estetra
Gedeon Richter Plc.
Conditions:
Contraception
Eligibility:
FEMALE
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 stu...
Detailed Description
Rationale and background: 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 DRS...
Eligibility Criteria
Inclusion
- • New users of E4/DRSP or EE/DRSP or EE/LNG or EE/NGM or EE/NETA
Exclusion
- • Women who have given birth six weeks before treatment starts will be excluded from the study.
Key Trial Info
Start Date :
April 24 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
68100 Patients enrolled
Trial Details
Trial ID
NCT06186271
Start Date
April 24 2025
End Date
June 1 2029
Last Update
August 20 2025
Active Locations (1)
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1
Berlin Center for Epidemiology and Health Research
Berlin, State of Berlin, Germany, 10115