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Title: Clinical tolerance of a combined monophasic contraceptive agent containing a low-dose of ethinyloestradiol and gestodene in adolescents.
Author: Leonard F, Gaspard U, Theunissen L.
Journal: Curr Med Res Opin; 1993; 13(2):78-86. PubMed ID: 8325045.
Abstract:
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) The clinical effects and the contraceptive effectiveness of a monophasic preparation containing 30 mg ethinylestradiol and 75 mg gestodene per tablet were assessed in a study of 115 healthy adolescents (mean age, 18.5 +or- 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). 88% of cycles presented a normal bleeding pattern from the 2nd 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 1st menstrual cycles but only in 5% of the 2nd 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 (76-82 mmHg after 6 months). The patients showed a tendency to gain weight (54.4-56.7 kg after 6 months). It should be borne in mind, however, that this study was carried out in growing adolescents. It can be concluded, therefore, that this preparation is an effective contraceptive in spite of an inadequate use in 11% of cycles. The observed side effects were sporadic and not serious, indicating that the balance of this hormone combination was not too estrogenic or too progestogen-androgenic. Unjustified interruptions of the treatment were due to the young age and the low degree of compliance in this particular age group.

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