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  • Title: Clinical experience with a triphasic oral contraceptive ('Trinordiol') in young women.
    Author: Gaspard UJ, Deville JL, Dubois M.
    Journal: Curr Med Res Opin; 1983; 8(6):395-404. PubMed ID: 6406157.
    Abstract:
    Seven hundred and fifty cycles of treatment with a new triphasic oral contraceptive (WL-49(50). 'Trinordiol') containing the lowest quantity of steroids of all available preparations were evaluated in 75 healthy young women (mean age 19.6 years), 70% of whom had regular, normal cycles. Sixty-five percent had not used contraception before; the others had previously been on combined or progestagen-only oral contraceptives or had an IUD. The mean length of treatment with the triphasic preparation was 10 cycles. No pregnancy was recorded during the 750 cycles of treatment. Fifteen (20%) women dropped out of the study for medical reasons, essentially breast tenderness, weight increase, spotting and nausea, in decreasing order of frequency. Mastalgia was present in 21% of the women (8.9% of the cycles) during triphasic oral contraception, but this symptom disappeared in more than half of the cases within 3 months of continued use. Other side-effects were less frequent: vaginal discharge (4.4% of the cycles), nausea (3.7%), abdominal and leg cramps (2.8%), headaches (3.2%) and weight increase (3%). Spotting and breakthrough bleeding were reported during only 1.9% of the cycles, a remarkably low frequency. No absence of withdrawal bleeding was noted. Weight and blood pressure changes were minimal and never reached statistical significance. Hypertension developed during triphasic medication in 1 predisposed individual. Complaints of oestrogen-related symptoms such as breast tenderness and digestive disorders were probably due to the reduced progestagen content of the preparation compared with combined low fixed daily dose oral contraceptives. However, no increases in dysmenorrhoea and/or premenstrual tension were noted. It is concluded that the triphasic preparation provides effective contraception with excellent cycle control and minimal side-effects, which should help to increase the acceptability of low-dose combined oral contraceptives. 750 cycles of treatment with a new triphasic oral contraceptive (OC), (WL-49(50), Trinordiol), containing the lowest quantity of steroids of all available preparations were evaluated in 75 healthy young women (mean age 19.6 years). 70% of all young women had normal, regular menstrual cycles. 65% had not used contraception previously, and the others had previously taken combined or progestogen only OCs or had an IUD. The mean length of treatment with the triphasic preparation was 10 cycles. Routine clinical evaluation, including gynecological examination, weight and blood pressure measurement, assessment of cycle events, and recording of spontaneously reported side effects, was performed every 3 months. Cycle control during triphasic OC use was very good. There was a statistically significant trend of the cycles toward more regularity than prior to this type of contraception, with an increased frequency of 28-day cycles. Duration of menses was significantly reduced and menstrual volume was more frequently rated by the women as normal. Spotting and breakthrough bleeding showed a very low frequency, the latter accounting for less than 10% of intermenstrual bleeding during triphasic OC medication. Frequency of side effects was 53.3% (40 women) during triphasic OC use. 20% of the population reported side effects among the reasons for stopping triphasic OC use. Breast tenderness was the most frequent side effect recorded in almost 9% of the total number of treatment cycles. It affected 21% of the women under study, a significantly more frequent occurrence than before triphasic OC use in these individuals. The tendency of this symptom to improve was observed in more than half of the cases within 3 months use of triphasic OC use. Other signs of estrogenic dominance such as gastrointestinal disturbances, vaginal discharge, pelvic congestion, and leg cramps were also present but much less prominent than breast tenderness. 16 (21.3%) patients presented with breast tenderness for 67 (8.9%) cycles. Nausea and vomiting were experienced by 6 (8%) patients for 28 (3.7%) cycles. Vaginal discharge was present in 10 (13.3%) patients for 33 (4.4% cycles). Spotting and breakthrough bleeding occurred in 6 (8%) women for 14 (1.9% cycles). Absence of change in weight was recorded in 1/3 of the women studied; another 1/3 experienced a weight reduction of 1-4 kg and the last 1/3 gained 1-4 kg. There were no statistically significant variations in either systolic or diastolic blood pressure values.
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