CLINICAL-EXPERIENCE WITH A MODERN LOW-DOSE GESTODENE-CONTAINING ORAL-CONTRACEPTIVE IN ADOLESCENTS

This clinical investigation of a low-dose, monophasic gestodene-contai ning oral contraceptive (75 mu g gestodene/30 mu g ethinylestradiol), investigated contraceptive efficacy, tolerability, cycle control and c ompliance in 5602 adolescents. The investigation was carried out over a period of 6 cycles. The average age of the study population was 16.4 years; however, only 12 women (0.2%) were under the age of 14. With r egard to contraceptive efficacy, during the course of the study there were 5 pregnancies, of which 3 were attributed to user failure. Two pr egnancies were recorded as method failure, giving a Pearl Index of 0.0 8. Cycle control with monophasic gestodene was observed to be excellen t. The incidence of spotting and breakthrough bleeding was low and dec lined during the course of the study, as did amenorrhea. The preparati on was tolerated well and the incidence of side-effects was low, with only 4.4% of women withdrawing from the study due to adverse events. A n increase in body weight was uncommon, and, at cycle 6, 91.2% of wome n had not gained weight. At the end of the study, 85.0% of women rated monophasic gestodene as good and 9.6% as satisfactory.