A 12-MONTH COMPARATIVE CLINICAL INVESTIGATION OF 2 LOW-DOSE ORAL-CONTRACEPTIVES CONTAINING 20-MU-G ETHINYLESTRADIOL 75-MU-G CESTODENE AND 20-MU-G ETHINYLESTRADIOL 75-MU-G DESOGESTREL, WITH RESPECT TO EFFICACY,CYCLE CONTROL AND TOLERANCE

The aim of this study was to compare contraceptive reliability, cycle control and tolerance of an oral contraceptive containing 20 mu g ethi nylestradiol and 75 mu g gestodene, with a reference preparation conta ining the same dose of estrogen combined with 150 mu g desogestrel. Th is article presents interim data from centers in France and Austria, i nvolving a total of 479 women and 4,991 cycles. Contraceptive;reliabil ity was good with both preparations. Two pregnancies occurred in the g estodene group, but neither were due to method failure. In the desoges trel group there were also two pregnancies, of which one was due to me thod failure. With respect to cycle control, there is a trend towards a lower incidence of intermenstrual bleeding in the gestodene group. T he incidence of spotting (scanty bleeding) during the important first three cycles was 3.5% lower in the gestodene group, and over the first six cycles, it was 7.6% lower. Amenorrhea was similar in both groups, but the incidence of dysmenorrhea was significantly lower in the gest odene group (p = 0.001). Adverse events were similar in both groups, w ith headache, breast tension and nausea the most frequently reported s ymptoms. Body weight remained relatively constant during treatment in both groups, and no hypertension was reported for any woman during the course of the study. In each treatment group, 19 women discontinued b ecause of adverse events. It is concluded that both preparations are r eliable and well tolerated oral contraceptives; however, there is a mo re favourable effect on dysmenorrhea by the gestodene formulation.