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
Use of Testosterone to Prevent Post-Surgical Muscle Loss - Pilot Study
- Conditions
- Muscle AtrophySurgeryTraumaKnee Injuries and DisordersComplication of Surgical Procedure
- Interventions
- Other: Normal Saline 3 ML IM Injection
- First Posted Date
- 2020-07-02
- Last Posted Date
- 2021-08-31
- Target Recruit Count
- 15
- Registration Number
- NCT04456530
- Locations
- 🇺🇸
Stone Research Foundation, San Francisco, California, United States
The Role of Follicle Stimulating Hormone in Advanced Prostate Cancer
- Conditions
- Prostate Cancer Recurrent
- Interventions
- Drug: Gonal F RFF Pen 900 UNT Per 1.5 ML Pen Injector
- 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
Assessment of Blood From Men Receiving Oral TU in Various Collection Tubes
- 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
- Conditions
- Fatty LiverPrediabetes/Type2 Diabetes MellitusHypogonadism, MaleOverweight/Obesity
- Interventions
- Drug: Placebo
- 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
- 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)
- Conditions
- Hypogonadism, MaleDiabetes Mellitus, Type 2Obesity
- Interventions
- 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
- Conditions
- Muscle LossBariatric Surgery CandidateMale Hypogonadism
- Interventions
- First Posted Date
- 2018-10-26
- Last Posted Date
- 2025-03-06
- 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
- Conditions
- Spinal Cord Injuries
- Interventions
- Behavioral: hybrid exercise
- First Posted Date
- 2018-07-03
- Last Posted Date
- 2025-05-06
- 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
- Conditions
- HypogonadismChronic Heart Failure
- Interventions
- 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
Drug Development Updates
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