The pharmacological profile of dienogest

M. Öettel, H Breitbarth, W Elger, T Gräser, Doris Hübler, G. Kaufmann, C. Moore, Vladimir K. Patchev, Wolfgang Römer, J. M. Schröder, Lothar Sobek, H. Zimmermann
In: The European Journal of Contraception & Reproductive Health Care · 1999 · vol. 4(sup1) , pp. 2–13 · doi:10.3109/13625189909085259 · W2118925018
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Dienogest, a novel 19-norprogestin, exhibits potent progestational and antiandrogenic activity with a favorable safety profile, demonstrating efficacy in reproductive applications and potential for antiproliferative drug development.

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Abstract

Dienogest is the first non-alkylated 19-norprogestin on the market. This so-called hybrid progestin combines the typical qualities of the modern 19-norprogestins with those of natural progesterone and synthetic hydroxyprogesterone derivatives. Toxicological investigations have revealed no serious toxic effects in vitro or any short- or long-term experiments in vivo, including carcinogenicity studies. The terminal half-life of dienogest varies between 8 and 10 hours in young cyclic women and between 11 and 12 hours in postmenopausal women (dose linearity for 1–8 mg/day and full absolute oral bioavailability). Progesterone receptor selectivity leads to a specific progestational action without other hormonal or antihormonal side-effects. An important exception in this respect is the antiandrogenic action of dienogest which has been clinically validated. Dienogest shows a strong peripheral progestational and antiproliferative efficacy, mainly on the ovary and uterus, and potent antiproliferative activities against experimental hormone-dependent cancer. The profile of dienogest is such that a specific ‘R&D tree’ may be constructed which extends from new and different approaches for contraception to bleeding-free hormone replacement and from the management of endometriosis to a new opportunity for development for antiproliferative drugs.

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endometriosis

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