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Abstract
A low-dose monophasic oral contraceptive containing 75μg of gestodene and 30μg of ethinylestradiol was evaluated for contraceptive reliability, cycle control and tolerability. The study was designed as a multicenter, open-label trial and involved a total of 285 women, aged 18 to 35 years, in nine centers, over six cycles. Contraceptive reliability was good and there were no pregnancies. Cycle control was excellent, as demonstrated by the decline in the incidence of breakthrough bleeding and spotting, culminating in their eventual absence by the end of cycle 6. Amenorrhea did not occur. There was significant moderation in cycle length, and duration and intensity of menstrual flow during the course of the study (p < 0.05). Treatment-related adverse events were reported by 37 (13%) subjects and were the cause of only one (0.3%) subject withdrawal. The most frequently reported were nausea (4.9%) and headache (3.9%). The occurrence of side-effects most commonly associated with oral contraception showed a decline throughout the study compared to baseline. Body weight was relatively constant with only 3.7% of subjects showing again of more than 2 kg, and blood pressure was unaltered. Therefore, the study preparation provided effective contraceptive protection, excellent cycle control and was well tolerated.