A 3-YEAR CLINICAL INVESTIGATION INTO EFFICACY, CYCLE CONTROL AND TOLERABILITY OF A NEW LOW-DOSE MONOPHASIC ORAL-CONTRACEPTIVE CONTAINING GESTODENE

This long-term, open-label, multicenter study investigated the clinica l efficacy and tolerability of a monophasic oral contraceptive contain ing 20 mu g ethinylestradiol and 75 mu g gestodene. A total of 670 wom en between the ages of 18 and 45 years received tile trial preparation over a 3-year period, giving 19 095 evaluable cycles. Of the 670 part icipants in the study, 75% completed at least 24 cycles with the trial preparation and 46% remained in the study for the full 3 years. One p regnancy occurred during the study which was considered by the investi gator to De tile result of misuse of the drug, giving an uncorrected P earl Index of 0.07. Cycle control with the trial preparation was good, especially in women who did not miss any pills. By cycle 3, only 10.2 % of women who had not missed pills reported intermenstrual bleeding ( scanty or medium/excessive bleeding) and this decreased to 2.3% by cyc le 36. The preparation was well tolerated, with a low incidence of unp rompted adverse events. There were no clinically significant changes i n mean body weight or blood pressure. Over the 3 years of the study, 1 0% of women withdrew from the study for reasons related mostly to mild adverse events. Results from this study demonstrate that the trial pr eparation is a reliable and well-tolerated oral contraceptive that pro vides good cycle control.