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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

The Effects of Semaglutide vs Testosterone Replacement Therapy on Functional Hypogonadism and Sperm Quality in Men With Type 2 Diabetes Mellitus and Obesity

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Obesity
Functional Hypogonadism
Interventions
First Posted Date
2024-07-08
Last Posted Date
2024-07-08
Lead Sponsor
University Medical Centre Ljubljana
Target Recruit Count
25
Registration Number
NCT06489457
Locations
🇸🇮

University Medical Centre Ljubljana, Ljubljana, Slovenia

A Phase 4 Study to Evaluate Adrenal Function in Hypogonadal Men Treated With JATENZO® for 12 Months

Phase 4
Active, not recruiting
Conditions
Hypogonadism
Interventions
First Posted Date
2024-04-26
Last Posted Date
2024-10-22
Lead Sponsor
Tolmar Inc.
Target Recruit Count
110
Registration Number
NCT06385509
Locations
🇺🇸

Alliance for Multispecialty Research, Norfolk, Virginia, United States

🇺🇸

Clinical Trials Research, Lincoln, California, United States

🇺🇸

Long Beach Research Institute, LLC, Long Beach, California, United States

and more 21 locations

Testosterone-induced Muscle Memory and Underlying Mechanisms

Not Applicable
Recruiting
Conditions
Skeletal Muscle Physiology
Interventions
First Posted Date
2024-01-03
Last Posted Date
2025-04-10
Lead Sponsor
Morten Hostrup, PhD
Target Recruit Count
30
Registration Number
NCT06188767
Locations
🇩🇰

The August Krogh Section for Human and Molecular Physiology, Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark

Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone?

Phase 2
Recruiting
Conditions
Age-Related Sarcopenia
Healthy Aging
Testosterone Deficiency
Interventions
First Posted Date
2023-07-28
Last Posted Date
2024-10-11
Lead Sponsor
Norwegian School of Sport Sciences
Target Recruit Count
40
Registration Number
NCT05964920
Locations
🇳🇴

Norwegian School of Sport Sciences, Oslo, Norway

Testosterone Undecanoate Replacement Therapy in Boys With Pubertal Delay or Confirmed Hypogonadism

Recruiting
Conditions
Delayed Puberty
Male Hypogonadism
First Posted Date
2022-09-15
Last Posted Date
2024-02-28
Lead Sponsor
Hospital de Niños R. Gutierrez de Buenos Aires
Target Recruit Count
27
Registration Number
NCT05541172
Locations
🇦🇷

Rodolfo Rey, Buenos Aires, Distrito Federal, Argentina

Testosterone Treatment in Men with Chronic Kidney Disease

Phase 2
Recruiting
Conditions
Kidney Disease, Chronic
Hypogonadism, Male
Interventions
First Posted Date
2022-02-21
Last Posted Date
2025-03-30
Lead Sponsor
St. Louis University
Target Recruit Count
20
Registration Number
NCT05249634
Locations
🇺🇸

Saint Louis Univeristy, Saint Louis, Missouri, United States

Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrate Resistant Prostate Cancer

Phase 2
Active, not recruiting
Conditions
Metastatic Castration-resistant Prostate Cancer
Prostate Cancer
Castration-resistant Prostate Cancer
Interventions
First Posted Date
2021-10-18
Last Posted Date
2025-05-11
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
30
Registration Number
NCT05081193
Locations
🇺🇸

Johns Hopkins Hospital, Baltimore, Maryland, United States

🇺🇸

Allegheny Health Network, Pittsburgh, Pennsylvania, United States

Patient Satisfaction After Switching to Oral Testosterone Undecanoate

Phase 4
Completed
Conditions
Testosterone Deficiency
Interventions
First Posted Date
2021-07-30
Last Posted Date
2023-12-14
Lead Sponsor
University of Miami
Target Recruit Count
41
Registration Number
NCT04983940
Locations
🇺🇸

University of Miami, Miami, Florida, United States

Effects of Testosterone Plus Dutasteride or Placebo on Muscle Strength, Body Composition and Metabolism in Transmen

Phase 3
Completed
Conditions
Transgenderism
Hypogonadism
Interventions
First Posted Date
2020-09-11
Last Posted Date
2020-09-11
Lead Sponsor
Unita Complessa di Ostetricia e Ginecologia
Target Recruit Count
16
Registration Number
NCT04545450

A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism

Phase 4
Completed
Conditions
Hypogonadism, Male
Hypogonadotropic Hypogonadism
Hypogonadism
Interventions
First Posted Date
2020-07-02
Last Posted Date
2025-03-14
Lead Sponsor
Endo Pharmaceuticals
Target Recruit Count
673
Registration Number
NCT04456296
Locations
🇺🇸

Endo Clinical Trial Site #22, Tucson, Arizona, United States

🇺🇸

Endo Clinical Trial Site #3, Oviedo, Florida, United States

🇺🇸

Endo Clinical Trial Site #27, Glen Burnie, Maryland, United States

and more 32 locations
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