Advertisement

Clinical comparison between a monophasic preparation and a triphasic preparation

  • U. Lachnit-Fixson
  • S. Aydinlik
  • J. Lehnert

Abstract

The triphasic preparation containing 6 coated tablets of 0.05mg levonorgestrel (LN) + 0.03 mg ethinyloestradiol (EE), 5 coated tablets of 0.075 mg LN + 0.04 mg EE and 10 coated tablets of 0.125 mg LN + 0.03 mg EE (Triquilar®/Logynon®) was compared in a randomized multicentre trial with a monophasic combined pill composed of 0.15mg desogestrel + 0.03mg ethinyloestradiol (Marvelon®).

The main purpose of this study — planned for 6 treatment cycles -was to elucidate possible differences in cycle stability, i.e. the incidence of spotting and breakthrough bleeding episodes and failure of withdrawal bleeding to occur. A total of 555 women were enrolled and completed 3060 cycles. In a randomized fashion 278 of the volunteers were assigned to the triphasic preparation (preparation 1), and 277 to the monophasic combination (preparation 2). 84.5% of the women completed the six months treatment period on both preparations. However, whereas only 6.1% of triphasic takers discontinued medication prematurely because of medical reasons (side-effects), 11.9% of the women on the monophasic preparations did so, mainly because of bleeding irregularities. Calculated in terms of the total number of triphasic cycles the spotting rate was 6.4%, the BTB rate 1.2%. In 0.4% of all cycles spotting + BTB were recorded in the same cycle. The corresponding figures for the monophasic preparation are as follows: spotting 16.5%, BTB 2.8% and spotting + BTB for the same cycles 1.1%. The amenorrhoea rate was 0.2% for the triphasic and 0.9% for the monophasic preparation.

All differences were statistically highly significant (Chi-square test) and not only confined to the beginning of medication, but also present in the 6th treatment cycle. Spotting rates in cycles 1 + 2 for preparation 1 = 10.9%, for preparation 2 = 28.5%; in cycle 6 for preparation 1 = 2.6%, for preparation 2 = 10.3%. BTB rates in cycles 1 + 2 for 1 = 2.0%, for 2 = 6.7%; in cycle 6 for 1 = 0.4%, for 2 = 2.2%.

Another interesting difference between the two preparations concerned body-weight, which remained constant in 75.2% of the triphasic users, but in only 61.1% of the monophasic users. Minor weight gains (+<2kg) occurred in 11.3% of women taking preparation 1 and in 15.4% of women on preparation 2. Only 5.2% of the triphasic users versus 16.7% of the women on the monophasic combination had gained more than 2 kg after 6 months. These differences were also statistically highly significant.

Keywords

Oral Contraceptive Ethinyl Estradiol Hormonal Contraception Fertility Control Coated Tablet 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Larsson-Cohn, U. (1982). Lipoproteins and the estrogenicity of oral contraceptives. In Haspels, A. A. and Rolland, R. (eds.). Benefits and Risks of Hormonal Contraception, p. 95. (Lancaster: MTP Press)Google Scholar
  2. 2.
    Briggs, M. H. (1982). Comparative investigation of oral contraceptives using randomized, prospective protocols. In Haspels, A. A. and Rolland, R. (eds.). Benefits and Risks of Hormonal Contraception, p. 115. (Lancaster: MTP Press)Google Scholar
  3. 3.
    Winckelmann, G., Kaiser, E. and Christi, H. L. (1982). Effects of a triphasic and a biphasic oral contraceptive on various hemostatic parameters. In Haspels, A. A. and Rolland, R. (eds.) Benefits and Risks of Hormonal Contraception, p. 104. (Lancaster: MTP Press)Google Scholar
  4. 4.
    World Heath Organization (1978). Steroid contraception and the risk of neoplasia. WHO Tech. Rep. Ser., 619 Google Scholar
  5. 5.
    Zador, G. (1982). Clinical performance of a triphasic administration of ethinyl estradiol and levonorgestrel in comparison with the 30 + 150μg fixed-dose regime. In Haspels, A. A. and Rolland, R. (eds.). Benefits and Risks of Hormonal Contraception, p. 43. (Lancaster: MTP Press)Google Scholar
  6. 6.
    Carlborg, L. (1982). Acceptability of low-dose oral contraceptives: results of a randomized Swedish multicenter study comparing a triphasic (Trionetta®) and a fixed-dose combination (Neovletta®). In Haspels, A. A. and Rolland, R. (eds.). Benefits and Risks of Hormonal Contraception, p. 78. (Lancaster: MTP Press)Google Scholar
  7. 7.
    Bergink, E. W., et al. (1981). Binding of a contraceptive progestogen Org 2969 and its metabolites to receptor proteins and human sex hormone binding globulin. J. Ster. Biochem., 14, 175CrossRefGoogle Scholar

Copyright information

© MTP Press Limited 1984

Authors and Affiliations

  • U. Lachnit-Fixson
  • S. Aydinlik
  • J. Lehnert

There are no affiliations available

Personalised recommendations