Overview
Testosterone undecanoate is the ester prodrug of testosterone and has a mid-chain fatty acid at the carbon 17β position. It was developed via fatty acid esterification of testosterone in order to achieve orally administer testosterone. There are oral and intramuscular formulations available for testosterone undecanoate: both formulations are indicated for testosterone replacement therapy in adult males with hypogonadism. Testosterone is a critical male hormone that is responsible for the normal growth and development of the male sex organs and for the maintenance of secondary sex characteristics. Male hypogonadism, resulting from insufficient testosterone secretion, can result symptoms and signs of testosterone deficiency, such as decreased libido, erectile dysfunction, and loss of muscle and bone mass. Testosterone replacement therapy aims to restore the levels of testosterone, thereby improving symptoms and signs of testosterone deficiency.
Background
Testosterone undecanoate is the ester prodrug of testosterone and has a mid-chain fatty acid at the carbon 17β position. It was developed via fatty acid esterification of testosterone in order to achieve orally administer testosterone. There are oral and intramuscular formulations available for testosterone undecanoate: both formulations are indicated for testosterone replacement therapy in adult males with hypogonadism. Testosterone is a critical male hormone that is responsible for the normal growth and development of the male sex organs and for the maintenance of secondary sex characteristics. Male hypogonadism, resulting from insufficient testosterone secretion, can result symptoms and signs of testosterone deficiency, such as decreased libido, erectile dysfunction, and loss of muscle and bone mass. Testosterone replacement therapy aims to restore the levels of testosterone, thereby improving symptoms and signs of testosterone deficiency.
Indication
Testosterone undecanoate is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. These conditions include: Testosterone undecanoate is not used to treat age-related hypogonadism.
Associated Conditions
- Testosterone Deficiency
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2016/11/17 | Phase 1 | Completed | |||
2016/03/03 | Phase 2 | Completed | |||
2015/08/04 | Phase 3 | Completed | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud | ||
2013/08/09 | Phase 2 | Completed | |||
2013/03/18 | Phase 4 | Completed | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia | ||
2012/12/31 | N/A | UNKNOWN | |||
2012/11/12 | Phase 2 | Completed | |||
2012/01/25 | Phase 2 | Terminated | Health Sciences Centre, Winnipeg, Manitoba | ||
2012/01/18 | Phase 4 | Terminated | |||
2010/09/21 | Phase 2 | Completed | University of Roma La Sapienza |
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