CLINICAL TOLERANCE OF A COMBINED MONOPHASIC CONTRACEPTIVE AGENT CONTAINING A LOW-DOSE OF ETHINYLESTRADIOL AND GESTODENE IN ADOLESCENTS

The clinical effects and the contraceptive effectiveness of a monophas ic preparation containing 30 mug ethinyloestradiol and 75 mug gestoden e per tablet were assessed in a study of 115 healthy adolescents (mean age 18.5 +/- 2 years) covering a total of 712 menstrual cycles (mean of 8 cycles per patient). There was a number of cases of discontinuati on of the study (70/115), mainly due to poor discipline in tablet inta ke in this particular age group. Only 20 cases discontinued the study for medical reasons. No pregnancies occurred, in spite of the fact tha t tablets were frequently forgotten (11% of cycles). Eighty-eight perc ent of cycles presented a normal bleeding pattern from the second mont h of treatment on. Spotting was sporadic (less than 8% from the 2nd cy cle) and was mainly associated with tablet omission. Intermenstrual bl eeding (breakthrough bleeding) occurred in 19% of the first menstrual cycles but only in 5% of the second and following cycles. Tenderness o f the breast was the most frequent subjective complaint (3.4% of cycle s), followed by urogenital problems, headaches and digestive disorders . However, all complaints remained sporadic (13.4% of cycles). The sys tolic blood pressure showed little variation, with only a slight incre ase from 123 to 125 mmHg after 6 months of treatment. Though not clini cally important, an increase in diastolic blood pressure was observed (from 76 to 82 mmHg after 6 months). The patients showed a tendency to increase weight (from 54.4 to 56.7 kg after 6 months). It should be b orne in mind, however, that this study was carried out in growing adol escents. It can be concluded, therefore, that this preparation is an e ffective contraceptive in spite of an inadequate use in 11% of cycles. The observed side-effects were sporadic and not serious, indicating t hat the balance of this hormone combination was not too oestrogenic or too progestogen-androgenic. Unjustified interruptions of the treatmen t were due to the young age and the low degree of compliance in this p articular age group.