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  • Title: Comparison of contraceptive acceptability of levonorgestrel and ethinyl oestradiol administered in one three-phasic (Trionetta) and one monophasic (Neovletta) version.
    Author: Carlborg L.
    Journal: Contraception; 1983 May; 27(5):439-52. PubMed ID: 6349925.
    Abstract:
    In a Swedish multicenter study, a total number of 835 women completed a total of 6472 treatment cycles. Half of them were allotted at random to use the monophasic oral contraceptive Neovletta, also known as Microgynon 30 (30 micrograms ethinyl oestradiol + 150 micrograms levonorgestrel in each tablet). The second half was allotted to Trionetta, also known as Triquilar, Trigynon and Logynon (6 tablets with 30 micrograms ethinyl oestradiol + 50 micrograms levonorgestrel, 5 tablets with 40 micrograms ethinyl oestradiol + 75 micrograms levonorgestrel and 10 tablets with 30 micrograms ethinyl oestradiol + 125 micrograms levonorgestrel). The latter version was also present in a 28-day version containing in addition 7 "placebo" tablets to be used in the otherwise tablet-free interval. The contraceptive reliability was excellent although one pregnancy occurred in the three-phase version. It could be attributed to patient failure. In all aspects of bleeding control, the three-phasic pill proved to be superior to the reference monophasic preparation. The extreme low incidence of missed withdrawal bleeding and stability already during the first months of use are noteworthy features. For both preparations, continuation rate was at six months of use about 85% and at 12 months it was a similar figure. The most common reason for withdrawal was bleeding, about 5% each for both preparation. No serious side-effects were reported. The study clearly indicates that the three-phasic version is a major improvement in spite of a considerably decreased total dose of the gestagen. A total of 835 women in a Swedish multicenter study completed a total of 6472 oral contraceptive (OC) treatment cycles; half of the women were allotted at random to use the monophasic OC Neovletta, also known as Microgynon 30 (30 mcg ethinyl estradiol + 150 mcg levonorgestrel in each tablet) and the 2nd half was allotted to Trionetta, also known as Triquilar, Trigynon, and Logynon (6 tablets with 30 mcg ethinyl estradiol + 50 mcg levonorgestrel, 5 tablets with 40 mcg ethinyl estradiol + 75 mcg levonorgestrel and 10 tablets with 30 mcg ethinyl estradiol + 125 mcg levonorgestrel). The latter version was also present in a 28-day version containing in addition 7 placebo tablets to be used in the otherwise tablet-free interval. There was a comparatively high number of missed tablets. Tablets were omitted in 8.1% of the total number of cycles in the triphasic group and the corresponding figure for the monophasic group was 9.4%. Despite this fact, only 1 pregnancy occurred during the observation period and during treatment with Trionetta 21. This pregnancy was classified by the attending physician as clearly due to patient failure (3 consecutively missed tablets). Both formulations exerted a normalizing effect on cycle length, being more pronounced with the triphasic formulation. The 2 combinations reduced to the same extent previously prolonged bleeding periods, i.e., greater than 7 days. The percentage of women with bleeding periods longer than 7 days in the 6th and 12th treatment cycle was 1.4% and 0.6%, respectively, for Neovletta and 0.9% and 0.6%, respectively for Trionetta. The 2 combinations reduced to the same extent previously profuse bleedings. In the last untreated cycle, the percentage of women with profuse bleeding was 6.7% in the Neovletta group and 9.1% in the Trionetta group. Failure of getting withdrawal bleeding was rare in both treatment groups, but the triphasic formulation was found to be superior to the fixed dose combination. In the Neovletta group 85.9% completed the 1st trial period of 6 cycles. The corresponding figure for Trionetta was 83.9%. Acne and headache were, for both formulations, reported less frequently during treatment than in the last untreated cycle. 1 case of thrombophlebitis was reported during treatment with Neovletta. There was no statistically significant increase of the mean blood pressure or the mean body weight during treatment.
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