Clinical tolerance of a combined monophasic contraceptive agent containing a low-dose of ethinyloestradiol and gestodene in adolescents.
The clinical effects and the contraceptive effectiveness of a monophasic preparation containing 30 micrograms ethinyloestradiol and 75 micrograms gestodene 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 discontinuation of the study (70/115), mainly due to poor discipline in tablet intake in this particular age group. Only 20 cases discontinued the study for medical reasons. No pregnancies occurred, in spite of the fact that tablets were frequently forgotten (11% of cycles). Eighty-eight percent of cycles presented a normal bleeding pattern from the second month of treatment on. Spotting was sporadic (less than 8% from the 2nd cycle) and was mainly associated with tablet omission. Intermenstrual bleeding (breakthrough bleeding) occurred in 19% of the first menstrual cycles but only in 5% of the second and following cycles. Tenderness of the breast was the most frequent subjective complaint (3.4% of cycles), followed by urogenital problems, headaches and digestive disorders. However, all complaints remained sporadic (13.4% of cycles). The systolic blood pressure showed little variation, with only a slight increase from 123 to 125 mmHg after 6 months of treatment. Though not clinically 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.(ABSTRACT TRUNCATED AT 250 WORDS)
Leonard
F
F
Department of Gynaecology, University of Liège, CHU Sart Tilman, Belgium.
Gaspard
U
U
Theunissen
L
L
D000293:Adolescent; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage* / Q000009:adverse effects; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects; D009652:Norpregnenes / Q000008:administration & dosage* / Q000009:adverse effects
D003277:Contraceptives, Oral, Combined; D009652:Norpregnenes; C055368:Femovan; C033273:Gestodene; D004997:Ethinyl Estradiol