International Active Surveillance Study: Safety of Estrogen Estetrol (E4) Contraceptive Study (INAS-SEECS)

Sponsor
Center for Epidemiology and Health Research, Germany
Study ID
NCT06186271
Status
Recruiting
Apply to this trial

Conditions

  • Contraception

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Dec 29, 2023
Start date
Apr 24, 2025
Status verified
Mar 2025
Primary completion
Dec 31, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
68,100 participants (estimated)

Arms

  • Arm: E4/DRSP
    E4/DRSP: estetrol/drospirenone new users (starters and restarters with at least two months break)
  • Arm: EE/DRSP
    EE/DRSP: ethinyl estradiol/drospirenone new users (starters and restarters with at least two months break)
  • Arm: EE/LNG and EE/NETA and EE/NGM
    EE/LNG: ethinyl estradiol/levonorgestrel EE/NETA: ethinyl estradiol/norethisterone/norethindrone acetate EE/NGM: ethinyl estradiol/norgestimate new users (starters and restarters with at least two months break)

Primary Outcome Measure

Co-primary endpoint considering the time-to-VTE event, specifically: New VTE [ Time Frame: Up to 24 months post baseline ]

Central Contacts

Related Studies