International Active Surveillance Study: Native Estrogen Estetrol (E4) Safety Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorCenter for Epidemiology and Health Research, Germany
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Approximately 50,500 E4/ DRSP users and 50,500 EE/LNG new users, including adolescents (below the age of 18 years eligible based on local legislation) will be recruited via recruitment centres.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
101,000 Participants
are grouped into 2 trial groupsGroup A: Estetrol/drospirenone (E4/DRSP)
Group B: Ethinyl estradiol/levonorgestrel (EE/LNG)
Trial outcomes
Primary outcomes
1
Incidence rate of Venous Thromboembolism (VTE)
* Occurrence (or absence) of a new (non-recurrent) confirmed Deep Venous Thrombosis (DVT) of the lower extremities (International Classification of Diseases, 10th revision (ICD-10) codes: I80.1 and I80.2) and, * Occurrence (or absence) of a new (non-recurrent) confirmed Pulmonary Embolism (PE) (ICD-10 codes: I26.0 and I26.9)
Time frame
Up to 24 months post baselineSecondary outcomes
1
Incidence rate of all VTEs, including thromboses of the renal, mesenteric, portal, cerebral and retinal veins
The occurrence (or absence) of a new (non-recurrent) confirmed VTE. A sensitivity analysis will be done for the ICD-10 code I80.3
Time frame
Up to 24 months post baseline2
Incidence rate of Arterial Thromboembolism (ATE), including acute myocardial infarction (AMI) and cerebrovascular accidents (CVA)
The occurrence (or absence) of new (non-recurrent) confirmed ATE, AMI, and CVA: ICD-10 code I21; CVA: ICD-10 code: I24.9, G45.\*, I61.\*, I63.1, I63.2, I63.3, I63.4, I63.5, I63.8, I63.9
Time frame
Up to 24 months post baseline3
Incident rate of unintended pregnancy
The occurrence of unintended pregnancy
Time frame
Up to 24 months post baseline4
Incident rate of neonatal malformations associated with foetal exposure to E4/DRSP and EE/LNG in E4/DRSP users and users of EE/LNG
Occurrence of major congenital malformations, according to classification by the European network of population-based registries for the epidemiological surveillance of congenital anomalies (EUROCAT), as reported during follow-up among pregnancies observed * Stillbirth (defined as foetal death with a gestational age ≥20 weeks) * Neonatal death (defined as deaths occurring among live births during the first 28 completed days of life) * Spontaneous/elective abortion (defined as a loss of pregnancy at a gestational age \<20 weeks) * Termination of pregnancy for foetal anomaly (TOPFA \[where prenatal diagnosis was made of malformation in a live foetus and the pregnancy was then terminated\]) * Preterm delivery (defined as delivery strictly before 37 completed weeks of gestation) * Low birth weight (defined as a birth weight \<2,500g) * Small for gestational age infants
Time frame
Up to 24 months post baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Center for Epidemiology and Health Research, Germany
Lead sponsor
Estetra
Collaborator
Gedeon Richter Plc.
Collaborator
Source ClinicalTrials.gov