COMPARATIVE PROFILES OF RELIABILITY, CYCLE CONTROL AND SIDE-EFFECTS OF 2 OR AL CONTRACEPTIVE FORMULATIONS CONTAINING 150 MU-G DESOGESTREL AND EITHER 30 MU-G OR 20 MU-G ETHINYL ESTRADIOL

Objective To compare two oral contraceptive pills, both containing 150 mug desogestrel, but with either 20 mug (Mercilon(R)) or 30 mug (Marvelon(R)/Desolett(R)) ethinyl oestradiol (EE), regarding reliability, cycle control and side effect profile. Design A double blind, randomised, multicentre study over one year with follow up after three, six and 12 months. The women noted tablet intake and all bleedings on specifically designed diary cards. Setting University clinics, central hospitals and private gynaecological practices in Norway, Sweden and Denmark. Subjects One thousand women aged 18 to 40 years requesting oral contraceptive pills. Main outcome measures Reliability, cycle control, side effects, blood pressure, body weight and haemoglobin. Results In a total of 4543 cycles with the 20 mug EE dose pill and 4688 cycles with the 30 mug EE dose pill, the number of pregnancies ascribed to method failure were 0 and 2, respectively. Irregular bleeding (break-through bleeding or spotting) was significantly more frequent with the 150/20 combination in about two-thirds of the cycles randomly distributed over the one year of the study. Mean blood pressure decreased slightly, particularly in the group on the 150/20 combination (about 1 mmHg), whereas mean body weight increased approximately 0.5 kg in the group with the 150/30 combination after 12 months. Haemoglobin did not change. Side effects other than bleeding problems were rare, but dizziness and mood changes were more frequent in the group on the 150/20 combination. Due to side effects, more women on the 150/20 combination discontinued the study during the one to three and four to six month periods, and women on this pill were also less positive about continuing the study drug at the end of the trial. Conclusions Both pills have high contraceptive reliability and are well tolerated, but with the 150/20 combination the cycle control is less effective. However, in view of the potentially increased safety profile of the 150/20 combination, many women can be expected to accept some additional discomfort due to irregular bleeding.