Combining estetrol with drospirenone resulted in a combined
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To evaluate the effect on endocrine and metabolic parameters of a new combined oral contraceptive containing estetrol (E4) and drospirenone (DRSP) a study was conducted. Combining estetrol 15 mg with DRSP 3 mg resulted in a combined oral contraceptive with a different metabolic profile in comparison to ethinylestradiol-containing products. The clinical relevance of these findings needs to be further assessed, using clinical endpoints to establish the safety profile of this new combined oral contraceptive.

Estetrol 15 mg/ drospirenone 3 mg treatment has limited effects on endocrine and metabolic parameters. The effects on gonadotropins, cortisol, CBG, angiotensinogen, SHBG, and triglycerides were less pronounced compared to ethinylestradiol-containing products.

Randomized, open-label, controlled, three-arm, parallel study. Healthy subjects received either estetrol 15 mg/ drospirenone 3 mg (n=38), or ethinylestradiol (EE) 30 µg/ levonorgestrel (LNG) 150 µg (n=29), or ethinylestradiol 20 µg/ drospirenone 3 mg (n=31) for 6 treatment cycles. Median percentage change from baseline to cycle 3 and to cycle 6 were evaluated for endocrine parameters, liver proteins, lipid profile, and carbohydrate metabolism.

At Cycle 6, estetrol 15 mg/ drospirenone 3 mg treatment had less effect on gonadotropins (FSH +30.5%, LH -7.5%) compared to ethinylestradiol/ levonorgestrel (FSH -84.0%, LH -92.0%) and ethinylestradiol/DRSP (FSH -64.0%, LH -90.0%). With estetrol 15 mg/ drospirenone 3 mg increases in total cortisol (+26.0%) and CBG (+40%) were less compared to ethinylestradiol/ levonorgestrel (cortisol +109%, CBG +152.0%) and estetrol 15 mg/ drospirenone 3 mg. Liver proteins, except CRP, increased, but the effect was less pronounced with estetrol 15 mg/ drospirenone 3 mg for angiotensinogen (+75.0%) compared to EE/ levonorgestrel (+170.0%) and estetrol 15 mg/ drospirenone 3 mg (+206.5%) and for SHBG (+55.0%), compared to ethinylestradiol/ levonorgestrel (+74.0%) and estetrol 15 mg/ drospirenone 3 mg (+251.0%). estetrol 15 mg/ drospirenone 3 mg had minimal impact on lipid parameters; the largest effect was observed for triglycerides (+24.0%), which was less compared to ethinylestradiol/ levonorgestrel (+28.0%) and estetrol 15 mg/ drospirenone 3 mg (+65.5%). estetrol 15 mg/ drospirenone 3 mg had no effect on carbohydrate metabolism.

Source: https://www.sciencedirect.com/science/article/abs/pii/S0010782421000020?dgcid=rss_sd_all
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