International Active Surveillance Study: Native Estrogen Estetrol (E4) Safety Study (INAS-NEES)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06028555 |
Recruitment Status :
Recruiting
First Posted : September 8, 2023
Last Update Posted : September 8, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease |
---|
Contraception Birth Control |
Study Type : | Observational |
Estimated Enrollment : | 101000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | International Active Surveillance Study: Native Estrogen Estetrol (E4) Safety Study |
Actual Study Start Date : | June 28, 2023 |
Estimated Primary Completion Date : | October 31, 2028 |
Estimated Study Completion Date : | October 31, 2028 |
Group/Cohort |
---|
Estetrol/drospirenone (E4/DRSP)
Users: Starters and re-starters
|
Ethinyl estradiol/levonorgestrel (EE/LNG)
Users: Starters and re-starters
|
- Incidence rate of Venous Thromboembolism (VTE) [ Time Frame: Up to 24 months post baseline ]
- 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)
- Incidence rate of all VTEs, including thromboses of the renal, mesenteric, portal, cerebral and retinal veins [ Time Frame: Up to 24 months post baseline ]The occurrence (or absence) of a new (non-recurrent) confirmed VTE. A sensitivity analysis will be done for the ICD-10 code I80.3
- Incidence rate of Arterial Thromboembolism (ATE), including acute myocardial infarction (AMI) and cerebrovascular accidents (CVA) [ Time Frame: Up to 24 months post baseline ]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
- Incident rate of unintended pregnancy [ Time Frame: Up to 24 months post baseline ]The occurrence of unintended pregnancy
- Incident rate of neonatal malformations associated with foetal exposure to E4/DRSP and EE/LNG in E4/DRSP users and users of EE/LNG [ Time Frame: Up to 24 months post baseline ]
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
- Compare drug utilization pattern between users of both cohorts [ Time Frame: Up to 24 months post baseline ]The time-varying exposure to COCs observed from study entry through the follow-up period, with dates and duration of each contraceptive prescription.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
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 Criteria:
-
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06028555
Contact: Ulrike Amann-Gassner, Dr. | +49 30 945 101 20 | u.amann-gassner@zeg-berlin.de | |
Contact: Silke Zimmermann, Dr. | +49 30 945 101 20 | s.zimmermann@zeg-berlin.de |
Germany | |
Berlin Center for Epidemiology and Health Research | Recruiting |
Berlin, Germany, 10115 | |
Contact: Ulrike Amann-Gassner, Dr. +49 172 3135426 u.amann-gassner@zeg-berlin.de |
Principal Investigator: | Klaas Heinemann, Dr. | ZEG Berlin GmbH |
Responsible Party: | Klaas Heinemann, MD, PhD, Managing director, Center for Epidemiology and Health Research, Germany |
ClinicalTrials.gov Identifier: | NCT06028555 |
Other Study ID Numbers: |
ZEG2022_02 |
First Posted: | September 8, 2023 Key Record Dates |
Last Update Posted: | September 8, 2023 |
Last Verified: | August 2023 |