Comparative study on the acceptability of two modern monophasic oral contraceptive preparations: 30 mu g ethinyl estradiol combined with 150 mu g desogestrel or 75 mu g gestodene
L. Zichella et al., Comparative study on the acceptability of two modern monophasic oral contraceptive preparations: 30 mu g ethinyl estradiol combined with 150 mu g desogestrel or 75 mu g gestodene, ADV CONTRAC, 15(3), 1999, pp. 191-200
Cycle control and tolerability of two monophasic oral contraceptive pills c
ontaining 30 mu g ethinyl estradiol (EE) with either 150 mu g desogestrel (
DSG) or 75 mu g gestodene (GSD) were compared in women starting oral contra
ception.
A minimum of 200 healthy women at risk for pregnancy were to be treated for
a total of 6 cycles per patient in a prospective, randomized open parallel
-group multicenter trial.
Two hundred and forty-one subjects were randomized, 115 to DSG/EE and 126 t
o GSD/EE. Compliance to the study preparation was high (around 95%) in both
groups and no pregnancies occurred during the study. Cycle control was exc
ellent; there were no differences between the two groups with regard to inc
idence of spotting and breakthrough bleeding or duration and intensity of w
ithdrawal bleeding. Side-effects were mild and in general comparable in the
two groups. Both at baseline and during treatment, a higher proportion of
women taking GSD/EE complained about breast tenderness. This resulted in mo
re early withdrawals because of breast tenderness in the GSD/EE group.
It was concluded that monophasic DSG/EE and GSD/EE are equally effective, h
ave similar cycle control and both are generally well tolerated.