Normophasic preparation containing progestogen desogestrel and ethinylestradiol

A Finnish multicenter study was carried out on 157 healthy fertile volunteers (2157 cycles) to evaluate an oral normophasic contraceptive preparation comprising 7 tablets of 0.050 ethinyl estradiol followed by 15 tablets of 0.050 mg ethinyl estradiol + 0.125 mg desogestrel. Bleeding patterns, side effects, liver function, and dropouts were recorded, as well as the development of the endometrium. No pregnancies occurred. Irregular bleeding (spotting and breakthrough bleeding) occurred in 12% of the 1st treatment cycle and in only 4% after 1 year's treatment. The most common side effects were nausea and headache. 17 women dropped out because of subjective side effects after 12 treatment cycles. No changes of any clinical importance were seen in mean body weight or liver function tests. Most of the endometrial biopsies showed a secretory pattern with mild hypoplasia. No hyperplastic or malignant changes were seen.