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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
Clinical Trials
Related News

Assessment of Blood From Men Receiving Oral TU in Various Collection Tubes

Phase 1
Completed
Conditions
Hypogonadism, Male
Interventions
Drug: Testosterone Undecanoate
First Posted Date
2019-06-04
Last Posted Date
2019-07-09
Lead Sponsor
Clarus Therapeutics, Inc.
Target Recruit Count
13
Registration Number
NCT03973840
Locations
🇺🇸

Clarus Therapeutics, Inc, Northbrook, Illinois, United States

Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Overweight/Obese Men With T2DM or Prediabetes and Hypogonadism

Phase 4
Recruiting
Conditions
Fatty Liver
Prediabetes/Type2 Diabetes Mellitus
Hypogonadism, Male
Overweight/Obesity
Interventions
Drug: Placebo
Drug: Testosterone Undecanoate
First Posted Date
2019-02-22
Last Posted Date
2024-03-13
Lead Sponsor
Alexandra Kautzky-Willer
Target Recruit Count
32
Registration Number
NCT03851627
Locations
🇦🇹

Abt. für Endokrinologie & Stoffwechsel, Univ. Klin f. Innere Medizin III, Wien, Austria

Xiaflex® Plus Testosterone Treatment Pilot Study Protocol

Phase 4
Completed
Conditions
Peyronie's Disease (PD)
Interventions
Drug: Xiaflex®
Drug: Aveed
First Posted Date
2019-01-24
Last Posted Date
2020-12-31
Lead Sponsor
Men's Health Boston
Target Recruit Count
20
Registration Number
NCT03815331
Locations
🇺🇸

Men's Health Boston, Chestnut Hill, Massachusetts, United States

Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2 Diabetic Patients" (SETH2)

Phase 4
Completed
Conditions
Hypogonadism, Male
Diabetes Mellitus, Type 2
Obesity
Interventions
Drug: Testosterone Undecanoate
Drug: Placebo
First Posted Date
2019-01-03
Last Posted Date
2019-01-04
Lead Sponsor
University Medical Centre Ljubljana
Target Recruit Count
55
Registration Number
NCT03792321

Testosterone in Bariatric Patients

Phase 4
Active, not recruiting
Conditions
Muscle Loss
Bariatric Surgery Candidate
Male Hypogonadism
Interventions
Drug: Testosterone Undecanoate
First Posted Date
2018-10-26
Last Posted Date
2024-01-17
Lead Sponsor
Esbjerg Hospital - University Hospital of Southern Denmark
Target Recruit Count
64
Registration Number
NCT03721497
Locations
🇩🇰

HospitalSWD, Esbjerg, Denmark

Multimodality Intervention for Function and Metabolism in SCI

Phase 2
Recruiting
Conditions
Spinal Cord Injuries
Interventions
Drug: Testosterone Undecanoate
Behavioral: hybrid exercise
First Posted Date
2018-07-03
Last Posted Date
2024-08-27
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
84
Registration Number
NCT03576001
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

Effects of Testosterone on Myocardial Repolarization

Phase 4
Completed
Conditions
Hypogonadism
Chronic Heart Failure
Interventions
Drug: Testosterone Undecanoate
First Posted Date
2017-04-24
Last Posted Date
2017-05-08
Lead Sponsor
University of Roma La Sapienza
Target Recruit Count
123
Registration Number
NCT03126656

Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism

Phase 1
Completed
Conditions
Male Hypogonadism
Interventions
Drug: DITEST
Drug: Testosterone undecanoate
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

Phase 2
Completed
Conditions
Hypogonadism
Interventions
Drug: Testosterone undecanoate
Drug: Testosterone enanthate
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

Phase 3
Completed
Conditions
Obesity
Hypogonadism
Interventions
Drug: Metformin + Testosterone Undecanoate
Drug: Placebo
Drug: Metformin
Drug: Testosterone Undecanoate
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

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