Journal Article10.1007/S00345-003-0372-X
A new oral testosterone undecanoate formulation
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TL;DR: Testosterone undecanoate will be available in a new formulation with castor oil and propylene glycol laurate instead of oleic acid, thus improving storage conditions markedly and evaluating the efficacy and safety of the new formulation in the treatment of elderly men with late-onset hypogonadism.
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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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References
Oral Testosterone Supplementation Increases Muscle and Decreases Fat Mass in Healthy Elderly Males With Low–Normal Gonadal Status
Gary A. Wittert,Ian Chapman,Matthew T. Haren,Shylie Mackintosh,Penelope Coates,John E. Morley +5 more
TL;DR: Oral testosterone administration to older relatively hypogonadal men results in an increase in muscle mass and a decrease in body fat over a 12-month period.
361
Androgen replacement with oral testosterone undecanoate in hypogonadal men: a double blind controlled study
TL;DR: Sexual interest increased within the first week of T.U. administration, ejaculation usually returning within the second week, and behaviour responses were similar in the hyper‐ and hypogonadotrophic groups.
353
Outcomes of Long-Term Testosterone Replacement in Older Hypogonadal Males: A Retrospective Analysis
TL;DR: Long term testosterone replacement to date appears to be a safe and effective means of treating hypogonadal elderly males, provided that frequent follow-up blood tests and examinations are performed.
321
Androgen replacement therapy in male patients with rheumatoid arthritis.
TL;DR: Seven men with active RA were treated daily for 6 months with oral testosterone undecanoate plus a nonsteroidal antiinflammatory drug in an attempt to evaluate the immunologic response, the overall clinical response, and the sex hormone response to such replacement therapy.
224
Oral testosterone undecanoate reverses erectile dysfunction associated with diabetes mellitus in patients failing on sildenafil citrate therapy alone
TL;DR: Low testosterone levels in patients with ED and type II DM receiving oral antidiabetic agents may be responsible for failure to respond to sildenafil citrate therapy, and combination with oral testosterone undecanoate restores sexual function in these patients.
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