International Active Surveillance Study: Native Estrogen Estetrol (E4) Safety Study

Sponsor
Center for Epidemiology and Health Research, Germany
Study ID
NCT06028555
Status
Recruiting
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Conditions

  • Birth Control
  • Contraception

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

First listed
Sep 8, 2023
Start date
Jun 28, 2023
Status verified
Aug 2025
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
101,000 participants (estimated)

Arms

  • Arm: Estetrol/drospirenone (E4/DRSP)
    Users: Starters and re-starters
  • Arm: Ethinyl estradiol/levonorgestrel (EE/LNG)
    Users: Starters and re-starters

Primary Outcome Measure

Incidence rate of Venous Thromboembolism (VTE) [ Time Frame: Up to 24 months post baseline ]

Central Contacts

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