INAS-NEES - Native Estrogen Estetrol (E4) Safety Study

• Research type

  Research Study

• Full title

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

• IRAS ID

  331006

• Contact name

  Hannat Akintomide

• Contact email

  akintomideh@gmail.com

• Sponsor organisation

  Estetra SRL

• Clinicaltrials.gov Identifier

  EUPAS49984, ENCePP

• Duration of Study in the UK

  5 years, 8 months, 30 days

• Research summary

  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). E4 is a natural oestrogen only produced during pregnancy by the foetal liver. When combined with the progestin DRSP, ovulation is inhibited. The E4/DRSP combination may have less impact on hepatic and haemostasis parameters in comparison to combinations of ethinyl estradiol (EE) and levonorgestrel (LNG) or EE and DRSP. Yet, it is unknown whether this regimen has an impact on the cardiovascular risk associated with the use of hormonal contraceptives.

• REC name

  South West - Frenchay Research Ethics Committee

• REC reference

  23/SW/0104

• Date of REC Opinion

  8 Feb 2024

• REC opinion

  Further Information Favourable Opinion