{"paper_id":"fa3cef0a-635f-4cb6-beb0-8cdd701c09fa","body_text":"Abstract\n-\n▴ Estradiol valerate/dienogest is an oral contraceptive for women that combines the natural estrogen estradiol with the 19-nortestosterone derivative dienogest in a four-phasic formulation.\n-\n▴ Estradiol valerate/dienogest demonstrated contraceptive efficacy in a large (n=1377), non-comparative, multicentre study in women aged 18–50 years, with 13 pregnancies over 1797.5 women-years of exposure generating an unadjusted Pearl Index (PI) of 0.73 (upper limit of 95% CI 1.24) [primary endpoint]. Six of the pregnancies were attributed to method failure, resulting in an adjusted PI, based on 1786.5 women-years of exposure, of 0.34 (upper limit of 95% CI 0.73).\n-\n▴ In a double-blind study in 798 women aged 18–50 years, estradiol valerate/dienogest and ethinylestradiol/levonorgestrel demonstrated an acceptable bleeding pattern and level of cycle control, according to several co-primary endpoints.\n-\n▴ As reported in the UK manufacturer’s summary of product characteristics, the unadjusted PI for women aged 18–35 years or 18–50 years in a pooled analysis of clinical studies was 1.01 (upper limit of 95% CI 1.59) and 0.79 (upper limit of 95% CI 1.23). This pooled analysis of three studies excluded those pregnancies occurring within 14 days of the cessation of therapy.\n-\n▴ Estradiol valerate/dienogest was generally well tolerated in this population, with the nature of adverse events generally similar across the studies and between estradiol valerate/dienogest and ethinylestradiol/levonorgestrel.\nSimilar content being viewed by others\nReferences\nMoore C, Elger W, Graeser T, et al. Different alternatives for the substitution of ethinylestradiol in oral contraceptives. In: Kuhl H, Nikolov R, editors. Re-evaluation of contraceptive steroids. Bad Blankenburg: Harfe Verlag, 1998: 25–35\nEndrikat J, Parke S, Trummer D, et al. Ovulation inhibition with four variations of a four-phasic estradiol valerate/ dienogest combined oral contraceptive: results of two prospective, randomized, open-label studies. Contraception 2008 Sep; 78(3): 218–25\nRowlands S. New technologies in contraception. 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Available from URL: http://www.viva.vita.bayerhealthcare.com/index.php?id=36&no_cache=1&tx_ttnews[tt_news]=13235 [Accessed 2009 Jul 9]\nAuthor information\nAuthors and Affiliations\nCorresponding author\nRights and permissions\nAbout this article\nCite this article\nHoy, S.M., Scott, L.J. Estradiol Valerate/Dienogest. Drugs 69, 1635–1646 (2009). https://doi.org/10.2165/11202820-000000000-00000\nPublished:\nIssue date:\nDOI: https://doi.org/10.2165/11202820-000000000-00000","source_license":"CC0","license_restricted":false}