[Incidence of side effects of a 3-stage preparation administered to 10,034 women]

In an open multicentre study, 10,034 women received a low-dose three-phase combination of levonorgestrel and ethinylestradiol for oral hormonal contraception. Duration of this treatment was three months. During this time, incidence of side effects were documented by reports of the patients or in reply to questions of the treating gynaecologists. Data has been analysed with special regard to smoking, obesity and increase of blood pressure. Upon inquiry, 38.1% of women had complaints before and 28.5% after treatment with this oral contraceptive, whereby in 16.9% of patients, complaints were noted for the first time. The observed side effects were more pronounced in smokers than in non-smokers, in obese women more than in those with normal weight, and more pronounced in patients with increased blood pressure compared to normal controls. Cycles became regular, whereas the number of spottings increased. Dysmenorrhoea disappeared almost completely. In the same time interval, genital infections were less prominent. During treatment, 26 patients (0.26%) became pregnant. It is concluded, that this triphasic combination with its varying ratios of ethinylestradiol and levonorgestrel is an effective and well tolerated oral contraceptive. It is shown, that the incidence of side effects is affected by additional risk factors.