Multicenter evaluation of a new low-dose triphasic oral contraceptive containing ethinylestradiol and gestodene (Tri-Minulet®), and its effect on the quality of life

To evaluate the effect of a low-dose, triphasic oral contraceptive containing gestodene and ethinylestradiol (Tri-Minulet®) on the subjective quality of life and general well-being of women, and to evaluate its efficacy, safety and cycle control, a total of 724 women, aged from 14 to 41 years, were enrolled in this open-label, non-comparative, multicenter study which was conducted over six cycles. Contraceptive reliability was good, and there were no pregnancies during the study. The duration and amount of menstrual flow decreased, and cycle control was good (4% spotting and 1.4% breakthrough bleeding at cycle 6 of the study). The incidence of breakthrough bleeding decreased significantly as did spotting, for all cycles compared to cycle 1 (p < 0.001 and p < 0.05, respectively). The study preparation was well tolerated. At the first assessment phase during study medication intake at cycle 3, 197 of 696 women (28.3%) reported adverse events. Tliis incidence declined to 11.9% (68 of 573 women) at cycle 6. Of the 545 women from whom data were available, there was no clinically significant change in weight (mean weight at baseline, after three and six cycles of intake was 60.08 kg (SD 9.7), 60.13 kg (SD 9.21) and 60.18 kg (SD 9.07), respectively. Blood pressure was not adversely affected during the study. During the first three cycles of the study, the self-assessed quality of life improved significantly (p < 0.0001), with a potential trend towards further improvement thereafter. Although this improvement in quality of life appeared to be largely independent of cycle control, there was some evidence of an association in women reporting 'good' or 'very good' well-being. The improvement in the rating of quality of life found in both new users of oral contraceptives and those who had switched from another oral contraceptive, suggested that this effect was not a general effect of oral contraceptive use, but was specific to Tri-Minulet. Tri-Minulet appears to be a safe and effective oral contraceptive that offers excellent cycle control. Furthermore, the study has demonstrated that women taking Tri-Minulet show a significant improvement in their general well-being.