EFFICACY, CYCLE CONTROL AND SIDE-EFFECTS OF 2 MONOPHASIC COMBINATION ORAL-CONTRACEPTIVES - GESTODENE ETHINYLESTRADIOL AND NORGESTIMATE/ETHINYLESTRADIOL/

Two monophasic oral contraceptives containing gestodene (GTD, 75 mu g) and ethinylestradiol (EE, 30 mu g) or norgestimate (NGS, 250 mu g) an d EE (35 mu g) were compared during the first six cycles of use. The s ubjects were randomly assigned to receive either type: 97 received GTD /EE and 92 NGS/EE. Six women in the GTD/EE group and nine in the NGS/E E group withdrew from the study; three (3%) and two (2%), respectively , withdrew because of adverse reactions. A total of 562 cycles for GTD /EE and 523 for NGS/EE were available. No woman became pregnant during the study. Overall, 94.4% of cycles in the GTD/EE group and 92.8% in the NGS/EE group were normal. A similar incidence of breakthrough blee ding (0.2% of cycles for GTD and 1.6% for NGS) and spotting (5.4% vs. 5.6%) was observed. Amenorrhea was never reported. Duration of withdra wal bleeding tended to be slightly longer in the NGS/EE group, signifi cantly so far cycles 2 (0.5 days, p = 0.016), 4 (0.5 days, p = 0.031) and 5 (0.4 days, p = 0.045). Cycle 2 was significantly longer in the G TD/EE group (0.3 days, p = 0.027). Side-effects were reported by 12 (1 2%) women in the GTD/EE group and 13 (14%) in the NGS/EE group. The mo st common side-effects were headache (five cases (5%) in the GTD/EE gr oup and two (2%) in the NGS/EE group) and breast pain (three (3%) and eight (9%) cases respectively). There were no statistically significan t differences between the two groups with respect to change in body we ight or changes in blood pressure and in laboratory data. In conclusio n, gestodene and norgestimate ave equally effective and produce no cli nically significant differences in cycle control characteristics.