Results of randomized controlled trial of levenorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception

Abstract

Objectives. Randomized double-blind investigation has been carried out in 21 centers of the World comparing levonorgestrel with Yuzpe regimen of combined oral contraceptives for emergency contraception.

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Methods. 1998 women with normal menstrual cycle, not using hormonal contraception and requesting emergency contraception were enrolled in the study. Women administered levonorgestrel (0,75 mg, repeated the same doze 12 hours later) or combined oral contraceptives (ethinylestradiol-100mg + levonorgestrel 0,5 mg repeating the same dose 12 hours later) within 72 hours of unprotected coitus.

Results. The outcome was unknown for 43 women. Among the remaining 1955 women, belonging to levonorgestrel group, the pregnancy rate was 1,1 (11/976), as for the women belonging to combined oral contraceptives group -32% (31/979). Nausea and vomiting among the women of levonorgestrel group occurs rarely in comparison with the group of combined oral contraceptives - Yuzpe regimen (p=0,01).

Conclusions. The levonorgestrel regimen is better tolerated and more effective than the standard Yuzpe method in hormonal emergency contraception. With either regimen, the earlier the treatment is given, the more effective it seems to be.