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 study will address post-market requirements for E4/DRSP under section 505(o) in response to the Food and Drug Administration (FDA) request.
The primary objective of the study is to characterize and compare the risks of E4/DRSP with EE/DRSP and E4/DRSP with a pooled cohort of users of EE/LNG, EE/NETA, and EE/NGM combinations (non-DRSP-containing COCs) in a study population of actual users of these preparations under routine clinical practice. The main clinical outcome of interest is VTE.
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Approximately 68,100 study participants (22,700 E4/DRSP, 22,700 EE/DRSP, and 22,700 EE/LNG, EE/NETA, and EE/NGM users) will be recruited via a network of COC-prescribing HCPs in the USA.
Cohort
Prospective
Not listed
Co-primary endpoint considering the time-to-VTE event, specifically: New VTE
ICD-10 codes: I80.1, I80.2, I80.3, I80.8\*, I80.9, I81, I82.0, I82.2, I82.3, I82.8, I82.9, I26.\*, I63.6, I67.6, H34.8, K55.0, N28.0 The variable to determine the primary endpoint is: The average treatment effect is quantified as the hazard ratio (HR) of E4/DRSP to EE/DRSP and E4/DRSP to non-DRSP COCs. VTE events are measured as the occurrence (or absence) of a new (non-recurrent) confirmed VTE during follow-up.
Incidence rate and time-to-event of ATE, including acute myocardial infarction
AMI; ICD-10 code I21.\*) and cerebrovascular accidents (CVA; ICD-10 code: I24.9, G45.\*, I61.\*, I63.1, I63.2, I63.3, I63.4, I63.5, I63.8, I63.9
Incidence rate and time-to-event of deep venous thrombosis (DVT) of the lower extremities
ICD-10 codes: I80.1 and I80.2
Incidence rate and time-to-event of pulmonary embolism (PE)
ICD-10 code: I26.\*
Incidence rate and time-to-event of VTE and ATE, stratified analyses
Stratification by age, smoking, BMI, and COC user status \[first-time users and restarter\])
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Center for Epidemiology and Health Research, Germany
Lead sponsor
Estetra
Collaborator
Gedeon Richter Plc.
Collaborator
