E-Poster Presentation ESA-SRB-ANZBMS 2021

Patient satisfaction and endocrine and metabolic effects of estetrol, a novel estrogen, in combination with drospirenone for contraception (#321)

Susan Davis 1 , Christine Klipping 2 , Ingrid JM Duijkers 2 , Dan Apter 3 , Maud Jost 4 , Jean-Michel Foidart 4 5
  1. School of Public Health and Preventative Medicine, Monash, Melbourne, VIC, Australia
  2. dinoxBV, Groningen, The Netherlands
  3. VL-Medi Clinical Research Center, Helsinki, Finland
  4. R&D, Estetra SRL, an affiliate company of Mithra Pharmaceuticals, Liege, Belgium
  5. Department of Obstetrics and Gynaecology, University of Liege, Liege, Belgium

OBJECTIVE: To assess patient satisfaction and metabolic effects of a new oral contraceptive containing estetrol (E4) 15mg and drospirenone (DRSP) 3mg.

BACKGROUND: E4 is an estrogen exclusively produced by the human fetal liver. E4 plus DRSP demonstrated high contraceptive efficacy and an excellent safety profile in two phase-3 trials performed in Europe/Russia and North America.

METHODS: Data is derived from two separate 6-cycle, phase-2 studies in healthy participants.

E4/DRSP (n=79) participants provided data pertaining to well-being and satisfaction (Subject Satisfaction and Health-Related Questionnaire) in an open-label, multi-centre, dose-finding, parallel study with estradiol valerate (E2V)/dienogest (DNG) (n=78) as reference.

The impact of E4/DRSP (n=38) on endocrine and metabolic parameters was evaluated in a randomized, open-label, controlled, 3-arm, parallel study compared with ethinylestradiol (EE) 30μg/levonorgestrel (LNG) 150μg (n=29), or EE 20μg/DRSP 3mg (n=31). Median percentage changes from baseline to cycle 6 were assessed.

RESULTS: Overall well-being scores for E4/DRSP were comparable with E2V/DNG. At cycle 6, 73.1% of subjects were (very) satisfied using E4/DRSP vs. 67.6% subjects using E2V/DNG. The number of women willing to continue with the assigned study treatment was the highest in the 15mg E4/ DRSP group (82.1%)

Compared with EE/LNG and EE/DRSP, E4/DRSP induced less pronounced changes in cortisol (+26.0% vs. +109.0% and +107.0%), cortisol binding globulin (+40.0% vs. +152.0% and +140.0%), thyroxine binding globulin (+17% vs. +37% and +70%) and angiotensinogen (+75.0% vs. +170.0% and +206.5%). E4/DRSP had minimal lipid effects, with the largest effect on triglycerides (+24.0%), similar to EE/LNG (+28.0%) and less than EE/DRSP (+65.5%). E4/DRSP had no effect on carbohydrate metabolism and TSH remained relatively stable in all treatment groups.  No clinically relevant changes in blood pressure or pulse rate were observed.

CONCLUSION: E4/DRSP is associated with a high-user satisfaction. Compared to EE-containing contraceptives, E4/DRSP has limited effects on endocrine and metabolic parameters.