Clinical experience with a modern low-dose gestodene-containing oral contraceptive in adolescents.
This clinical investigation of a low-dose, monophasic gestodene-containing oral contraceptive (75 micrograms gestodene/30 micrograms ethinylestradiol), investigated contraceptive efficacy, tolerability, cycle control and compliance 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 regard to contraceptive efficacy, during the course of the study there were 5 pregnancies, of which 3 were attributed to user failure. Two pregnancies were recorded as method failure, giving a Pearl Index of 0.08. Cycle control with monophasic gestodene was observed to be excellent. The incidence of spotting and breakthrough bleeding was low and declined during the course of the study, as did amenorrhea. The preparation 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. An increase in body weight was uncommon, and, at cycle 6, 91.2% of women had not gained weight. At the end of the study, 85.0% of women rated monophasic gestodene as good and 9.6% as satisfactory.
Brill
K
K
Medical Department Pharmaceutical Division, Schering AG, Berlin, Germany.
Schnitker
J
J
Albring
M
M
D000293:Adolescent; D001794:Blood Pressure; D003276:Contraceptives, Oral / Q000009:adverse effects; D005260:Female; D006801:Humans; D008597:Menstrual Cycle; D009652:Norpregnenes / Q000009:adverse effects; D011247:Pregnancy; D014592:Uterine Hemorrhage / Q000139:chemically induced; D015430:Weight Gain
D003276:Contraceptives, Oral; D009652:Norpregnenes; C033273:Gestodene