Status:
RECRUITING
International Active Surveillance Study: Native Estrogen Estetrol (E4) Safety Study
Lead Sponsor:
Center for Epidemiology and Health Research, Germany
Collaborating Sponsors:
Estetra
Gedeon Richter Plc.
Conditions:
Contraception
Birth Control
Eligibility:
FEMALE
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...
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 DR...
Eligibility Criteria
Inclusion
- 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
- \-
Key Trial Info
Start Date :
June 28 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2028
Estimated Enrollment :
101000 Patients enrolled
Trial Details
Trial ID
NCT06028555
Start Date
June 28 2023
End Date
October 31 2028
Last Update
August 17 2025
Active Locations (1)
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1
Berlin Center for Epidemiology and Health Research
Berlin, State of Berlin, Germany, 10115