[Effect of hormonal contraceptives containing 0.05 mg ethinyl estradiol and 0.125 mg desogestrel in normophasic regimen (Oviol)].

This evaluation is based on data obtained from a multicentre trial in which to date 953 women have used the tested oral contraceptive for a total of 15,737 cycles (average 16.5 cycles, maximum 40). The contraceptive is a combination of an estrogen (ethinylestradiol) and a progestogen (desogestrel). It is designed to be used in 28-day cycles: 22 days of tablet-taking followed by 6 tablet-free days during which a withdrawal bleeding may normally be expected to occur. On days 1-7 the dose in 50 micrograms ethinylestradiol, and on days 8-22 it is 50 micrograms ethinylestradiol + 125 micrograms desogestrel. This trial shows the described oral contraceptive to be highly effective. No pregnancies occurred when the tablets were taken as directed: one pregnancy occurred in a cycle in which two tablets were missed and in which there was also an acute bout of gastroenteritis. No serious side effects occurred, and the incidence of minor complaints which arose was lower than during a non-treated control cycle. Cycle regularity was exceptionally good. Withdrawal bleedings occurred in 97.6% of the treated cycles. Spottings occurred in 3%, and breakthrough bleedings in 2.1%. These facts combine to suggest that the tested oral contraceptive is highly effective, safe, and very acceptable.