Estradiol + dienogest. Oral contraception: estradiol does not provide a therapeutic advantage
Prescrire International 19(106): 65-67
2010
ISSN/ISBN: 1167-7422 PMID: 20568487 Document Number: 646493
A monophasic combination of ethinylestradiol plus levonorgestrel or norethisterone is the oral contraceptive with which we have most experience. A quadriphasic combination of estradiol and dienogest was recently authorised in various European Union member states. The results of two non-comparative trials and one comparative trial versus ethinylestradiol + levonorgestrel suggest that the contraceptive efficacy of the estradiol + dienogest combination is no better than that of other oral contraceptives. In addition, there is no tangible difference in regulation of the menstrual cycle compared to the ethinylestradiol + levonorgestrel combination, as assessed by bleeding during and after dosing. The estradiol + dienogest combination has the same frequent and mild adverse effects as other combined contraceptives, such as nausea, breast tenderness and headache. In contrast, little is known of the potential cardiovascular adverse effects of the new combination, including the risk of thrombosis. Use of this quadriphasic combination is inconvenient. The monthly blister pack contains 5 different tablets, with different compositions, that must be taken in exactly the right order. In addition, a woman must follow complicated directions for catching up if she misses a pill, and they differ throughout the cycle. In practice, it is better to continue to use a well-documented combined contraceptive such as the monophasic ethinylestradiol + levonorgestrel combination.