A MULTICENTER COMPARATIVE TRIAL OF TRIPHASIC AND MONOPHASIC, LOW-DOSECOMBINED ORAL-CONTRACEPTIVES

A comparative multicenter clinical trial of two combined oral contrace ptives (OCs) was conducted at clinics located in the Sudan, Sri Lanka, Chile, the Dominican Republic and Ecuador. The trial was designed to determine if there were differences in efficacy, safety and acceptabil ity between a triphasic and a low-dose monophasic OC. This report incl udes analysis of 1088 women. At each center, subjects were randomly al located to one of the two OCs. Follow-up visits were scheduled at 1, 4 , 8 and 12 months after admission. There were two accidental pregnanci es attributed to user failure reported during the study period; one in the triphasic group and one in the monophasic group. Adverse experien ces were mainly minor with headaches and dizziness being the most comm on complaints; frequency of reports was similar in both groups. Cycle control was good in both groups with women in the triphasic group repo rting fewer complaints of intermenstrual bleeding. Both OCs were safe and effective.