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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

Pharmacokinetic Study to Determine Time to Steady-state

Phase 2
Completed
Conditions
Primary Hypogonadism
Male Hypogonadism
Secondary 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)

Phase 2
Completed
Conditions
Coronary Heart Disease
Interventions
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

TU 025 Keishi Bukuryo Gan for Post-menopausal Hot Flash Management

Phase 2
Completed
Conditions
Hot Flashes
Menopause
First Posted Date
2005-07-13
Last Posted Date
2010-10-26
Lead Sponsor
Plotnikoff, Gregory A., M.D.
Target Recruit Count
180
Registration Number
NCT00119418
Locations
🇺🇸

University of Minnesota General Clinical Research Center, Minneapolis, Minnesota, United States

The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly

Phase 3
Conditions
Malnutrition
Aging
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

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