Metabolic and haemostatic effects of estradiol valeratedienogest, a novel oral contraceptive: A randomized, open-label, single-centre study

Background and Objective: The hormonal components of combined oral contraceptives (COCs) have various metabolic and haemostatic effects. The objective of this study was to compare the metabolic and haemostatic effects of a novel COC comprising estradiol valerate/dienogest (E2V/DNG) with ethinylestradiol/levonorgestrel (EE/LNG). Methods: In a randomized, open-label study conducted in Germany over seven cycles, healthy women aged 1850 years received E2V/DNG (E2V 3mg on days 12, E2V 2mg/DNG 2mg on days 37, E2V 2mg/DNG 3mg on days 824, E2V 1 mg on days 2526, placebo on days 2728; n = 30) or EE/LNG (EE 0.03 mg/LNG 0.05mg on days 16, EE 0.04mg/LNG 0.075 mg on days 711, EE 0.03mg/LNG 0.125 mg on days 1221, placebo on days 2228; n = 28). The primary variables were the mean intraindividual relative changes from baseline to cycle 7 in high-density lipoprotein (HDL) and low-density lipoprotein (LDL) cholesterol levels. Changes in other lipid parameters, haemostatic parameters, sex hormone-binding globulin (SHBG), cortisolbinding globulin (CBG), carbohydrate metabolism parameters, blood pressure and body weight were also assessed. Results: Mean SD HDL cholesterol increased by 7.9%±21.8% with E2V/DNG and decreased by 2.3%±14.4% with EE/LNG. Mean ±SD LDL cholesterol decreased by 6.5%±15.9% with E2V/DNG and by 3.0%±17.4% with EE/LNG. Mean ±SD prothrombin fragment 1 + 2 and D-dimer levels remained essentially unchanged in the E2V/DNG group (-0.6%±30.3% and -2.1%±43.5%, respectively), but increased in the EE/LNG group (by 117.3%±358.0% and 62.9%±99.5%, respectively). Changes in other hepaticinduced parameters (SHBG, CBG) and carbohydrate metabolism were generally less pronounced with E2V/DNG versus EE/LNG. Body weight and blood pressure remained stable throughout the study in both treatment groups. Both formulations were well tolerated, with no serious adverse events reported. Conclusion: E2V/DNG had a minimal impact on metabolic and haemostatic parameters, and a more favourable effect than EE/LNG on lipid markers. © 2011 Adis Data Information BV. All rights reserved.