Testosterone undecanoate
- Generic Name
- Testosterone undecanoate
- Brand Names
- Aveed, Jatenzo, Kyzatrex, Tlando
- Drug Type
- Small Molecule
- Chemical Formula
- C30H48O3
- CAS Number
- 5949-44-0
- Unique Ingredient Identifier
- H16A5VCT9C
- 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
- Associated Therapies
- Hormone Replacement Therapy
Testosterone Replacement in Non-alcoholic Steatohepatitis (TEREPINS)
- Conditions
- Nonalcoholic SteatohepatitisHypogonadism
- Interventions
- First Posted Date
- 2013-08-09
- Last Posted Date
- 2017-04-26
- Target Recruit Count
- 3
- Registration Number
- NCT01919294
- Locations
- 🇬🇧
Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, South Yorkshire, United Kingdom
Benefit of the Treatment With Testosterone in Chronic Heart Failure Testosterone Deficiency Subjects
- Conditions
- Heart Failure
- Interventions
- Drug: Saline isotonic solutionDrug: Testosterone undecanoate
- First Posted Date
- 2013-03-18
- Last Posted Date
- 2017-12-13
- Lead Sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Target Recruit Count
- 14
- Registration Number
- NCT01813201
- Locations
- 🇪🇸
Cardiology Service, Hospital Universitario Virgen de la Arrixaca, Murcia, Spain
Testosterone Undecanoate and Quality of Life of Men and Spouses
- Conditions
- Hypogonadism
- Interventions
- First Posted Date
- 2012-12-31
- Last Posted Date
- 2012-12-31
- Lead Sponsor
- Meir Medical Center
- Target Recruit Count
- 80
- Registration Number
- NCT01758029
Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women
- Conditions
- Female Sexual Dysfunction
- Interventions
- Drug: placeboDrug: Testosterone undecanoate
- First Posted Date
- 2012-11-12
- Last Posted Date
- 2014-01-29
- Lead Sponsor
- Chulalongkorn University
- Target Recruit Count
- 70
- Registration Number
- NCT01724658
- Locations
- 🇹🇭
King Chulalongkorn memorial hospital, Bankok, Thailand
Oral Testosterone for Fatigue in Male Multiple Sclerosis Patients
- Conditions
- FatigueMultiple Sclerosis
- Interventions
- Drug: Testosterone undecanoateDrug: placebo
- First Posted Date
- 2012-01-25
- Last Posted Date
- 2014-07-08
- Lead Sponsor
- Health Sciences Centre, Winnipeg, Manitoba
- Target Recruit Count
- 3
- Registration Number
- NCT01516554
- Locations
- 🇨🇦
Health Sciences Centre, Winnipeg, Manitoba, Canada
Androgen for Leydig Cell Proliferation
- Conditions
- Hypergonadotropic CryptozoospermiaHypergonadotropic HypogonadismKlinefelter SyndromeHypergonadotropic Azospermia
- Interventions
- First Posted Date
- 2010-09-21
- Last Posted Date
- 2018-09-25
- Lead Sponsor
- University of Roma La Sapienza
- Target Recruit Count
- 56
- Registration Number
- NCT01206270
- Locations
- 🇮🇹
Dipartimento di Fisiopatologia Medica, Rome, Lazio, Italy
Pharmacokinetic Study to Determine Time to Steady-state
- Conditions
- Primary HypogonadismMale HypogonadismSecondary Hypogonadism
- Interventions
- First Posted Date
- 2009-06-02
- Last Posted Date
- 2020-12-11
- Lead Sponsor
- Clarus Therapeutics, Inc.
- Target Recruit Count
- 15
- Registration Number
- NCT00911586
- Locations
- 🇺🇸
Alabama Clinical Therapeutics, Birmingham, Alabama, United States
Testosterone and Myocardial Perfusion in Coronary Heart Disease (CHD)
- First Posted Date
- 2005-10-17
- Last Posted Date
- 2019-09-25
- Lead Sponsor
- Imperial College London
- Target Recruit Count
- 28
- Registration Number
- NCT00239590
- Locations
- 🇬🇧
Royal Brompton & Harefield NHS Trust, London, United Kingdom
The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly
- Conditions
- MalnutritionAging
- First Posted Date
- 2005-07-01
- Last Posted Date
- 2006-09-11
- Lead Sponsor
- University of Adelaide
- Target Recruit Count
- 200
- Registration Number
- NCT00117000
- Locations
- 🇦🇺
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Drug Development Updates
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