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
K. Brill et al., 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, Contraception, 54(5), 1996, pp. 291-297
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.