A new oral testosterone undecanoate formulation
Testosterone undecanoate has been available on the market for more than 20 years. This testosterone ester is used worldwide for oral treatment of male hypogonadism. So far, testosterone undecanoate has been dissolved in oleic acid, leading to inconvenient storage conditions. It will now be available...
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Published in | World journal of urology Vol. 21; no. 5; pp. 311 - 315 |
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Main Authors | , |
Format | Journal Article |
Language | English |
Published |
Heidelberg
Springer
01.11.2003
Berlin Springer Nature B.V New York, NY |
Subjects | |
Online Access | Get full text |
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Abstract | Testosterone undecanoate has been available on the market for more than 20 years. This testosterone ester is used worldwide for oral treatment of male hypogonadism. So far, testosterone undecanoate has been dissolved in oleic acid, leading to inconvenient storage conditions. It will now be available in a new formulation with castor oil and propylene glycol laurate instead of oleic acid, thus improving storage conditions markedly (stable at room temperature for approximately 3 years). Pharmacokinetic and pharmacodynamic studies have demonstrated bioequivalence of the old and the new formulation of testosterone undecanoate. Therefore, the results of studies that were performed with the old formulation can be transferred to the clinical use of the new formulation. Controlled studies have shown its efficacy in the treatment of symptoms associated with reduced serum testosterone levels. In these cases testosterone undecanoate improves bone mineral density, quality of life, muscle mass, libido and mood. Further studies will help evaluate the efficacy and safety of the new formulation in the treatment of elderly men with late-onset hypogonadism. |
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AbstractList | Testosterone undecanoate has been available on the market for more than 20 years. This testosterone ester is used worldwide for oral treatment of male hypogonadism. So far, testosterone undecanoate has been dissolved in oleic acid, leading to inconvenient storage conditions. It will now be available in a new formulation with castor oil and propylene glycol laurate instead of oleic acid, thus improving storage conditions markedly (stable at room temperature for approximately 3 years). Pharmacokinetic and pharmacodynamic studies have demonstrated bioequivalence of the old and the new formulation of testosterone undecanoate. Therefore, the results of studies that were performed with the old formulation can be transferred to the clinical use of the new formulation. Controlled studies have shown its efficacy in the treatment of symptoms associated with reduced serum testosterone levels. In these cases testosterone undecanoate improves bone mineral density, quality of life, muscle mass, libido and mood. Further studies will help evaluate the efficacy and safety of the new formulation in the treatment of elderly men with late-onset hypogonadism. |
Author | SCHILL, Wolf-Bernhard KÖHN, Frank-Michael |
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Keywords | Aging male Therapy Molecular form Replacement therapy Androgen Treatment efficiency Age criterion Libido Pharmacology Hypogonadism Genital diseases Quality of life Testosterone Mood Bone mass Substitution Testosterone undecanoate Pharmacokinetics |
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SubjectTerms | Administration, Oral Biological and medical sciences Gynecology. Andrology. Obstetrics Hormones. Endocrine system Humans Hypogonadism - drug therapy Male Male genital diseases Medical sciences Non tumoral diseases Pharmacology. Drug treatments Testosterone - administration & dosage Testosterone - analogs & derivatives Testosterone - pharmacokinetics Testosterone Congeners - administration & dosage Testosterone Congeners - pharmacokinetics |
Title | A new oral testosterone undecanoate formulation |
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