CLINICAL COMPARISON OF MONOPHASIC ORAL-CONTRACEPTIVE PREPARATIONS OF GESTODENE ETHINYL ESTRADIOL AND DESOGESTREL/ETHINYL ESTRADIOL/

The efficacy, cycle control, subjective complaints, and safety of mono phasic preparations of the oval contraceptives containing gestodene 75 meg plus ethinyl estradiol 30 meg versus desogestrel 150 mcg plus eth inyl estradiol 30 meg were compared in a 6-cycle, open-label, parallel , randomized, multicenter phase IV clinical study in Latin America, Of a total of 176 women in each group, 163 in the gestodene group and 16 0 in the desogestrel group completed 6 cycles, providing data for 1,01 5 and 1,006 cycles, respectively. Subject compliance was excellent; pi lls were missed during only 6.9% of the cycles in each group. No woman became pregnant during the study. Gestodene group exhibited significa ntly better cycle control as evidenced by the lower incidence of break through bleeding and spotting. Spotting in some cycles was reported by 11.9% of women taking the gestodene-combination compared with 21% of women taking the desogestrel-combination. Based on number of women, 86 .4% of the gestodene group reported all cycles were normal (no BTB) co mpared with 76.7% of the desogestrel group. Also, the women in the ges todene group reported a significantly lower incidence of nuisance side effects during treatment cycles. No amenorrhea was observed for eithe r group. There were no clinically significant differences between grou ps with respect to body weight, blood pressure, or laboratory evaluati ons. Seven women withdrew from the gestodene group and 8 women withdre w from the desogestrel group because of adverse reactions. The results of this study indicate that, although both OCs provided effective con traception, in comparison to the desogestrel-combination, the gestoden e-containing OC is associated with better cycle control, less bleeding , and fewer subjective complaints.