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
- Conditions
- Type 2 Diabetes MellitusObesityFunctional 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
- 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
Testosterone-induced Muscle Memory and Underlying Mechanisms
- Conditions
- Skeletal Muscle Physiology
- Interventions
- First Posted Date
- 2024-01-03
- Last Posted Date
- 2024-01-03
- Lead Sponsor
- Morten Hostrup, PhD
- Target Recruit Count
- 30
- Registration Number
- NCT06188767
Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone?
- Conditions
- Age-Related SarcopeniaHealthy AgingTestosterone Deficiency
- Interventions
- Drug: Testosterone Undecanoate + Resistance exercise trainingDrug: SalineDrug: Saline + Resistance exercise trainingDrug: Testosterone Undecanoate
- 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
- Conditions
- Delayed PubertyMale 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
Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrate Resistant Prostate Cancer
- Conditions
- Metastatic Castration-resistant Prostate CancerProstate CancerCastration-resistant Prostate Cancer
- Interventions
- First Posted Date
- 2021-10-18
- Last Posted Date
- 2024-06-20
- Lead Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Target Recruit Count
- 30
- Registration Number
- NCT05081193
- Locations
- 🇺🇸
Allegheny Health Network, Pittsburgh, Pennsylvania, United States
🇺🇸Johns Hopkins Hospital, Baltimore, Maryland, United States
Patient Satisfaction After Switching to Oral Testosterone Undecanoate
- 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
- Conditions
- TransgenderismHypogonadism
- 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
The Role of Follicle Stimulating Hormone in Advanced Prostate Cancer
- Conditions
- Prostate Cancer Recurrent
- Interventions
- Drug: Degarelix 120 MG [Firmagon]Drug: Gonal F RFF Pen 900 UNT Per 1.5 ML Pen InjectorDrug: Testosterone Undecanoate
- First Posted Date
- 2019-10-22
- Last Posted Date
- 2020-01-22
- Lead Sponsor
- Lund University
- Target Recruit Count
- 33
- Registration Number
- NCT04134130
- Locations
- 🇸🇪
Reproductive Medicine Center, Malmö, Sweden
Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations
- Conditions
- ExerciseCaloric RestrictionSleep
- Interventions
- First Posted Date
- 2019-10-09
- Last Posted Date
- 2022-10-07
- Lead Sponsor
- Pennington Biomedical Research Center
- Target Recruit Count
- 34
- Registration Number
- NCT04120363
- Locations
- 🇺🇸
Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States
Drug Development Updates
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