Evaluation of a new estradiol oral contraceptive: estradiol valerate and dienogest

Jeffrey T. Jensen

doi:10.1517/14656561003724713

Evaluation of a new estradiol oral contraceptive: estradiol valerate and dienogest

Jeffrey T. Jensen

In: Expert Opinion on Pharmacotherapy · 2010 · vol. 11(7) , pp. 1147–1157 · doi:10.1517/14656561003724713 · PMID:20367275 · W2139013777

review OA: closed CC0 ⤵ 11 in-corpus citations

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The estradiol valerate/dienogest oral contraceptive pill demonstrates high contraceptive efficacy and effective treatment for heavy menstrual bleeding in women aged 18-35.

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Abstract

IMPORTANCE OF THE FIELD: Since ethinyl estradiol is a potent activator of hepatic enzymes, the use of natural estradiol (E2) has been studied; but, until recently, bleeding control has hampered development of an E2 pill. AREAS COVERED IN THIS REVIEW: A historical review of oral contraceptive development leading to the successful design of an estradiol pill. Pharmacology, mechanism of action and clinical trials of contraceptive efficacy and bleeding profile of the estradiol valerate/dienogest (E2V/DNG) pill are reviewed. Details of two placebo-controlled treatment trials of the E2V/DNG pill in women with heavy menstrual bleeding are discussed. All available literature was searched using pubMed and additional data were obtained from published abstracts. WHAT THE READER WILL GAIN: Information on the novel features and indications for the E2V/DNG pill. TAKE HOME MESSAGE: The dynamic-dosing E2V/DNG oral contraceptive pill provides a highly effective contraceptive option with an adjusted Pearl Index (method failure) of 0.51 (upper limit of 95% CI 0.97) and unadjusted Pearl Index (user failure) of 1.01 (1.59) for women aged 18-35 years. In addition, two large randomized controlled trials have demonstrated that E2V/DNG provides effective treatment for women with heavy menstrual bleeding.

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References (43)

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Bleeding pattern and cycle control with an estradiol-based oral contraceptive: a seven-cycle, randomized comparative trial of estradiol valerate/dienogest and ethinyl estradiol/levonorgestrel via openalex
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[1] A multicenter, double-blind, randomized, placebo-controlled study of oral estradiol valerate/dienogest for the treatment of heavy and/or prolonged menstrual bleeding via openalex

[2] Bleeding pattern and cycle control with an estradiol-based oral contraceptive: a seven-cycle, randomized comparative trial of estradiol valerate/dienogest and ethinyl estradiol/levonorgestrel via openalex

[3] Efficacy and safety of a novel oral contraceptive based on oestradiol (oestradiol valerate/dienogest): A Phase III trial via openalex

[4] O319 A novel oral contraceptive comprising estradiol valerate/dienogest for the treatment of heavy and/or prolonged menstrual bleeding without organic cause: a double‐blind, randomised, placebo‐controlled trial via openalex

[5] Ovulation inhibition with four variations of a four-phasic estradiol valerate/dienogest combined oral contraceptive: results of two prospective, randomized, open-label studies via openalex

[6] Pharmacokinetics of an oral contraceptive containing oestradiol valerate and dienogest via openalex

[7] Randomized Trial of 2 Hormonal and 2 Prostaglandin‐inhibiting Agents in Women with a Complaint of Menorrhagia via openalex

[8] The pharmacological profile of dienogest via openalex

[9] doi:10.1136/bmj.b2921 via openalex

[10] doi:10.1016/j.contraception.2005.08.021 via openalex

[11] doi:10.1002/14651858.cd003989.pub5 via openalex

[12] doi:10.1016/s0010-7824(02)00445-6 via openalex

[13] doi:10.1016/s0029-7844(99)00524-4 via openalex

[14] doi:10.1016/0002-9378(85)90664-7 via openalex

[15] W2147783658 via openalex

[16] doi:10.1055/s-0038-1646528 via openalex

[17] doi:10.1016/0010-7824(80)90010-4 via openalex

[18] doi:10.1016/0010-7824(88)90038-8 via openalex

[19] doi:10.1016/0002-9378(87)90166-9 via openalex

[20] doi:10.1016/s0002-9378(99)70120-1 via openalex

[21] doi:10.1016/j.contraception.2006.08.004 via openalex

[22] doi:10.1016/0378-5122(82)90064-0 via openalex

[23] doi:10.1016/0010-7824(83)90014-8 via openalex

[24] doi:10.1111/j.0954-6820.1966.tb02880.x via openalex

[25] doi:10.1016/0010-7824(95)00161-3 via openalex

[26] doi:10.1016/j.contraception.2006.07.005 via openalex

[27] doi:10.1016/s0889-8545(05)70169-8 via openalex

[28] doi:10.1016/j.contraception.2004.05.013 via openalex

[29] doi:10.1097/01.aog.0000279448.62221.a8 via openalex

[30] doi:10.1016/j.maturitas.2005.01.004 via openalex

[31] doi:10.1016/0378-5122(88)90023-0 via openalex

[32] doi:10.1111/j.1471-0528.1979.tb11276.x via openalex

[33] doi:10.7326/0003-4819-142-11-200506070-00016 via openalex

[34] doi:10.1016/j.contraception.2006.01.001 via openalex

[35] doi:10.1210/jcem-63-5-1106 via openalex

[36] doi:10.1016/s0010-7824(96)00201-6 via openalex

[37] doi:10.1016/j.contraception.2006.12.019 via openalex

[38] doi:10.1210/en.2003-0192 via openalex

[39] doi:10.1067/mob.2002.122988 via openalex

[40] doi:10.1136/bmj.b2890 via openalex

[41] W1907235146 via openalex

[42] doi:10.1016/s0002-9378(89)80010-9 via openalex

[43] doi:10.1037/e609122007-001 via openalex