Investigation of the influence of two low-dose monophasic oral contraceptives containing 20 μg ethinylestradiol/75 μg gestodene and 30 μg ethinylestradiol/75 μg gestodene, on lipid metabolism in an open randomized trial

Abstract

An open comparison at a single center was performed in volunteers (n=58) randomly allocated to two treatment groups, one receiving tablets containing 20 μg ethinylestradiol (EE) + 75 μg gestodene, and the other 30 μg EE + 75 μg gestodene. The study consisted of three treatment-free precycles, followed by thirteen 28-day treatment cycles. Analysis of results revealed that there were no statistically significant differences between the two groups with regard to the plasma levels of HDL-cholesterol and its subfractions, LDL-cholesterol and apolipoproteins. There was, however, a trend toward a more favorable effect on HDL-cholesterol in the 20 μg EE group, where levels increased by 3% compared with the 30 μg EE group, where levels decreased by 9%. There was a statistically significant difference between the adjusted mean values of total triglycerides in the two groups in favor of the 20 μg EE group (+21%), compared with the 30 μg EE group (+64%) (p=0.029). Two serious adverse events were reported (lymphadenopathy and vertigo), but neither were considered to be causally related to either study medication. The formulation containing 75 μg gestodene and 20 μg EE was shown to be a reliable and well tolerated oral contraceptive, with a favorable lipid profile.