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
Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism
- First Posted Date
- 2016-11-17
- Last Posted Date
- 2019-11-26
- Lead Sponsor
- Diurnal Limited
- Target Recruit Count
- 25
- Registration Number
- NCT02966652
- Locations
- 🇬🇧
Sheffield Teaching Hospital - Royal Hallamshire Hospital, Sheffield, England, United Kingdom
Pilot Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men
- Conditions
- Hypogonadism
- Interventions
- First Posted Date
- 2016-03-03
- Last Posted Date
- 2018-11-01
- Lead Sponsor
- Clarus Therapeutics, Inc.
- Target Recruit Count
- 12
- Registration Number
- NCT02697188
- Locations
- 🇺🇸
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles, California, United States
🇺🇸dgd Research, Inc, San Antonio, Texas, United States
Testosterone, Metformin, or Both, for Hypogonadism in Obese Males
- Conditions
- ObesityHypogonadism
- Interventions
- First Posted Date
- 2015-08-04
- Last Posted Date
- 2024-12-13
- Lead Sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Target Recruit Count
- 107
- Registration Number
- NCT02514629
- Locations
- 🇪🇸
Hospital Uiversitario Virgen de la Victoria, Malaga, Spain
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 solution
- 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: placebo
- 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: 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
The Effect of 90-day Oral Testosterone Therapy in Chinese Males With Type 2 Diabetes (T2DM)
- Conditions
- Assess the Effects of a the 90-day Oral TS Study Regimen on PSA, IPSS, Haemoglobin and Haematocrit, and to Assess Adverse and Serious Adverse Events.
- Interventions
- First Posted Date
- 2012-01-18
- Last Posted Date
- 2016-01-06
- Lead Sponsor
- Singapore Clinical Research Institute
- Target Recruit Count
- 19
- Registration Number
- NCT01510847
- Locations
- 🇸🇬
EJ Tan Clinic & Surgery, Singapore, Singapore
🇸🇬Bukit Batok Medical Clinic, Singapore, Singapore
🇸🇬Frontier Medical Associates (Woodlands) Pte Ltd, Singapore, Singapore
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
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.