INVESTIGATION OF THE INFLUENCE OF 2 LOW-DOSE MONOPHASIC ORAL-CONTRACEPTIVES CONTAINING 20 MU-G ETHINYLESTRADIOL 75 MU-G GESTODENE AND 30 MU-G ETHINYLESTRADIOL 75 MU-G GESTODENE, ON LIPID-METABOLISM IN AN OPEN RANDOMIZED TRIAL

An open comparison at a single center was performed in volunteers (n=5 8) randomly allocated to two treatment groups, one receiving tablets c ontaining 20 mu g ethinylestradiol (EE) + 75 mu g gestodene, and the o ther 30 mu g EE + 75 mu g gestodene. The study consisted of three trea tment-free pre cycles, followed by thirteen 28-day treatment cycles. A nalysis of results revealed that there were no statistically significa nt differences between the two groups with regard to the plasma levels of HDL-cholesterol and its subfractions, LDL-cholesterol and apolipop roteins. There was, however, a trend toward a more favorable effect on HDL-cholesterol in the 20 mu g EE group, where levels increased by 3% compared with the 30 mu g EE group, where levels decreased by 9%. The re was a statistically significant difference between the adjusted mea n values of total triglycerides in the two groups in favor of the 20 m u g EE group (+21%), compared with the 30 mu g EE group (+64%) (p=0.02 9). Two serious adverse events were reported (lymphadenopathy and vert igo), but neither were considered to be causally related to either stu dy medication. The formulation containing 75 mu g gestodene and 20 mu g EE was shown to be a reliable and well tolerated oral contraceptive, with a favorable lipid profile. (C) 1996 Elsevier Science Inc.