Fertility Regulation Using “Triphasic” Administration of Ethinyl Estradiol and Levonorgestrel in Comparison with the 30 Plus 150 μg Fixed Dose Regime

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Abstract
A new generation of combined oral contraceptive containing staggering amounts of ethinyl estradiol and levonorgestrel (SH B 264 AB) was compared in a randomized multicentre trial with a well established low dose combined pill composed of 30 μg ethinyl estradiol plus 150 μg levonorgestrel (Neovletta®) in a total of 489 women over 2,777 cycles. the trial was planned to run for six consecutive months at three clinics in Sweden (296 women) whereas the remaining 193 volunteers were enrolled from clinics in Great Britain and Germany. the case report forms were designed in a fashion to permit evaluation of the two formulations with regard to their overall reliability and acceptability in terms of cycle control. No pregnancy occurred during the observation period. Out of the total number of patients approximately 90% completed the six months treatment period on both combinations. Bleeding irregularities, such as spotting and/or breakthrough bleeding occurred more frequently on Neovletta® compared with SH B 264 AB (15.7% versus 10.1% of women) although the total hormone intake is considerably lower using the triphasic formulation. Missed withdrawal bleeding was reported in 2.3% of the total cycles on the fixed combination and in 0.9% of the total cycles on the triphasic regime. of the 72 (14.7%) women, 36 on each drug, who did not complete the six months of treatment, 44 discontinued for medical reasons. the discontinuation rate for medical reasons, the most common of which was spotting, was 8% for both formulations. From the present study it can be concluded that the new triphasic formulation is just as safe as Neovletta®, but it seems to be superior to the fixed 30 μg ethinyl estradiol plus 150 μg levonorgestrel-pill in terms of a lower incidence of bleeding irregularities.

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