The efficacy, cycle control, subjective complaints, and safety of monophasic preparations of the
oral contraceptives containing
gestodene 75 mcg plus
ethinyl estradiol 30 mcg versus
desogestrel 150 mcg plus
ethinyl estradiol 30 mcg 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 160 in the
desogestrel group completed 6 cycles, providing data for 1,015 and 1,006 cycles, respectively. Subject compliance was excellent; pills were missed during only 6.9% of the cycles in each group. No woman became pregnant during the study.
Gestodene group exhibited significantly better cycle control as evidenced by the lower incidence of
breakthrough 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) compared with 76.7% of the
desogestrel group. Also, the women in the
gestodene group reported a significantly lower incidence of nuisance side effects during treatment cycles. No
amenorrhea was observed for either group. There were no clinically significant differences between groups with respect to
body weight, blood pressure, or laboratory evaluations. Seven women withdrew from the
gestodene group and 8 women withdrew from the
desogestrel group because of adverse reactions. The results of this study indicate that, although both OCs provided effective
contraception, in comparison to the
desogestrel-combination, the
gestodene-containing OC is associated with better cycle control, less
bleeding, and fewer subjective complaints.