Nebido (testosterone undecanoate depot injection) / Bayer, Grunenthal - LARVOL DELTA

From venipuncture to self-sampling DBS: a shift in monitoring testosterone levels (ESPE-ESE 2025) - "For patients receiving trt via deeply intramuscular testosteroneundecanoate injection, monitoring testosterone levels via DBS sampling at home is feasible, enhancing patient comfort and convenience. Patient education is needed to ensure proper collection of DBS samples, leading to high quality DBS and accurate testosterone quantification."

Cardiovascular

Self-injection experiences among transgender people on injectable gender-affirming hormone therapy: a narrative review. (PubMed, J Am Pharm Assoc (2003)) - "Based on the types of injection-related challenges identified, pharmacists, as one of the most accessible health care providers in the United States, are well-positioned to intervene and improve the experience of patients using injectable GAHT."

Journal • Review • Pain

Exercise Heart Rate Variability Suggests Parasympathetic Hyperactivity during Simulated Military Operations Irrespective of Testosterone Administration. (PubMed, Med Sci Sports Exerc) - "Exercise HRV metrics suggested parasympathetic hyperactivity despite concomitant increases in stress across the extended simulated military operations. A single dose of testosterone undecanoate does not appear to negatively affect the autonomic response to high stress in young health physically active males."

Journal

Long-term testosterone therapy in obese men with functional hypogonadism is associated with improved urinary function and quality of life (AUA 2025) - "We compared LUTS and quality of life (QoL) in men with functional hypogonadism and obesity treated with testosterone undecanoate (TU) vs an untreated control group, patient entry start: >16 years ago... In this study long-term TTh in men with functional hypogonadism and obesity improved urinary function and QoL (measured by AMS), while in the untreated group, urinary function and QoL worsened vs baseline. Due to the observational design, findings have to be interpreted with caution."

HEOR • Endocrine Disorders • Genetic Disorders • Obesity

Testosterone Replacement in Male Cancer Survivors with Fatigue and Low Testosterone (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Seattle Institute for Biomedical and Clinical Research | Trial completion date: Jan 2026 ➔ Jan 2027 | Trial primary completion date: Jan 2026 ➔ Jan 2027

Trial completion date • Trial primary completion date • Endocrine Disorders • Fatigue • Oncology

In brief: Azmiro - a single-dose injectable formulation of testosterone cypionate. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

A Randomized Controlled Trial Comparing Testosterone Enanthate and Testosterone Undecanoate as a Gender Affirming Hormonal Therapy in Trans Males. (PubMed, Clin Endocrinol (Oxf)) - "Both TE and TU is safe, effective and well tolerated GAHT among FtM transsexuals with no significant differences in clinical, biochemical and hormonal parameters. Testosterone undecanoate was preferred at the end of 1 year due to its long dosing intervals."

Journal • CNS Disorders • Hematological Disorders

Testosterone Treatment and Sexual Function in Men: Secondary Analysis of the T4DM (Testosterone for Diabetes) Trial. (PubMed, J Clin Endocrinol Metab) - "Testosterone treatment enhanced sexual desire and, to a lesser extent, erectile function, particularly in older men and those with higher waist circumference or depressive symptoms. Reduced waist circumference and depression independently improved sexual function."

Journal • CNS Disorders • Depression • Diabetes • Genetic Disorders • Metabolic Disorders • Psychiatry • Type 2 Diabetes Mellitus

T esters: Comparing Direct and Indirect Detection Methods of Multiple Routes of Testosterone Administration (clinicaltrials.gov) - P1 | N=14 | Completed | Sponsor: Sports Medicine Research and Testing Laboratory | Enrolling by invitation ➔ Completed | Trial completion date: Aug 2024 ➔ Nov 2024 | Initiation date: May 2024 ➔ Nov 2024 | Trial primary completion date: Aug 2024 ➔ Nov 2024

Trial completion • Trial completion date • Trial initiation date • Trial primary completion date

Semaglutide improved sperm morphology in obese men with type 2 diabetes mellitus and functional hypogonadism. (PubMed, Diabetes Obes Metab) - P3 | "Semaglutide markedly improved sperm morphology, total testosterone levels and symptoms of hypogonadism. These findings highlight semaglutide's potential as a therapeutic approach for men with obesity-related FH who desire fertility."

Journal • Diabetes • Endocrine Disorders • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone? (clinicaltrials.gov) - P2/3 | N=40 | Recruiting | Sponsor: Norwegian School of Sport Sciences | Not yet recruiting ➔ Recruiting

Enrollment open • Sarcopenia

Testosterone and resistance training improved physical performance and reduced fatigue in frail older men: 1 year follow-up of a randomized clinical trial. (PubMed, Aging Male) - P2/3 | "To improve health conditions among hypogonadal men ≥70 years of age using testosterone undecanoate (TU) injections, progressive strength training, and oral supplements of vitamin D, calcium, and protein...Compared to controls, only the Combo group experienced reduced fatigue and tiredness (p < 0.05). Fifty-two weeks of testosterone supplementation combined with progressive resistance training may enhance physical performance, alleviate fatigue, and had no notable detrimental impacts among males aged ≥70 suffering from mobility issues and testosterone insufficiency.Trial registration - Clinical Trials NCT02873559."

Clinical • Journal • Fatigue • Geriatric Disorders

Androgen-Induced, β-Catenin-Activated Hepatocellular Adenomatosis with Spontaneous External Rupture. (PubMed, Diagnostics (Basel)) - "He used Aveed (testosterone undecanoate injection) from age 17 and completely stopped one year before his presentation...Compared to normal hepatocytes from control tissue, the tumor cells were positive for nuclear AR (androgen receptor) expression but had no increased EZH2 (Enhancer of Zeste 2 Polycomb Repressive Complex 2 Subunit) protein expression. The case indicated that androgen-induced hepatocellular neoplasms should be included in the differential diagnosis of acute abdomen."

Journal • Fatigue • Gastrointestinal Cancer • Hematological Disorders • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Pain • Solid Tumor • AR • EZH2

Beneficial effects of exercise, testosterone, vitamin D, calcium and protein in older men-A randomized clinical trial. (PubMed, J Cachexia Sarcopenia Muscle) - "In men ≥70 years old with low-normal to low testosterone and mobility problems, supplements of testosterone, calcium, vitamin D and protein combined with progressive resistance training improved 30-s chair stand test performance, muscle strength and quality of life. Both tiredness and leg fat were reduced, and RR interval variability was increased. Significant adverse effects were not observed."

Clinical • Journal • Geriatric Disorders

De Novo Metastatic Breast Cancer after Bilateral Mastectomy in a Transgender Man Harbouring a Germline BRCA2 mutation (ENDO 2024) - "A multigenerational family history of breast cancer prompted genetic testing, identifying a BRCA2 germline mutation.Past medical history included brain stem glioma (diagnosed aged 13 years) with multiple intracranial surgeries, ventriculoperitoneal shunt, mild acquired brain injury, anxiety, and post-traumatic stress disorder.Anticancer treatment has consisted of chemotherapy (Abraxane, Capecitabine), endocrine therapy (Letrozole), targeted therapy (Palbociclib, Olaparib), radiotherapy, and antiresorptive therapy (Denosumab)...Risk reducing bilateral salpingo-oophorectomy (plus hysterectomy) was performed in February 2021; histology identified an atrophic endometrium and no pathologic features.Gender affirming hormone therapy was commenced in October 2017 in the form of testosterone undecanoate 1000mg intramuscularly every 12 weeks...Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the..."

Metastases • Back Pain • Brain Cancer • Breast Cancer • CNS Disorders • CNS Tumor • Dyslipidemia • Glioma • Gynecology • HER2 Breast Cancer • HER2 Positive Breast Cancer • Musculoskeletal Pain • Oncology • Pain • Post-traumatic Stress Disorder • Psychiatry • Solid Tumor • Vascular Neurology • BRCA • BRCA2 • HER-2 • PGR

Long-term testosterone therapy in men with functional hypogonadism is associated with improved lower urinary tract symptoms and quality of life (AUA 2024) - "409 men received testosterone undecanoate injections 1000 mg/12 weeks following an initial 6-week interval (T-group), 415 opted against TTh and served as controls (CTRL)... In men with functional hypogonadism, long-term TTh is associated with sustainably improved LUTS over 15 years. This may have contributed to improvements in QoL. In the untreated control group, LUTS and QoL deteriorated."

HEOR • Endocrine Disorders

T esters: Comparing Direct and Indirect Detection Methods of Multiple Routes of Testosterone Administration (clinicaltrials.gov) - P1 | N=15 | Enrolling by invitation | Sponsor: Sports Medicine Research and Testing Laboratory

New P1 trial

Prostate-specific antigen (PSA) levels in men with Prader-Willi syndrome. (PubMed, Growth Horm IGF Res) - "Levels of PSA were low. Long-term treatment with testosterone was working well and did not result in any clinically meaningful increase in PSA. Our results indicate that testosterone replacement is neither associated with serious adverse events regarding changes in behavior or effect on PSA. However, larger studies are needed to confirm our results."

Journal • Cognitive Disorders • Endocrine Disorders • Genetic Disorders • Prader–Willi syndrome

Testosterone therapy in men with classical versus functional hypogonadism: results from a controlled 9-years, real-world registry study. (PubMed, Andrology) - "The therapeutic outcomes of TTh across distinct hypogonadal populations demonstrate heterogeneous responses, significantly influenced by diagnostic categorization, age, and baseline risk factor profiles."

Journal • Real-world • Real-world evidence • Endocrine Disorders • Hematological Disorders • Obesity

Test2Func: Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Overweight/Obese Men With T2DM or Prediabetes and Hypogonadism (clinicaltrials.gov) - P4 | N=32 | Recruiting | Sponsor: Alexandra Kautzky-Willer | Trial completion date: Dec 2025 ➔ Dec 2028 | Trial primary completion date: Sep 2025 ➔ Sep 2028

Trial completion date • Trial primary completion date • Endocrine Disorders • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Effects of 12 Months' Treatment with Testosterone Undecanoate on Markers for Erythropoietic Activity and Safety Aspects in Transgender and Cisgender Hypogonadal Men. (PubMed, J Appl Lab Med) - "After 12 months of treatment with TU in naïve transgender men, hemoglobin and hematocrit increased to levels within the cisgender male reference range. A slight decrease in HDL-cholesterol was seen in naïve transgender men but liver enzymes remained unchanged."

Journal

Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone? (clinicaltrials.gov) - P2/3 | N=40 | Not yet recruiting | Sponsor: Norwegian School of Sport Sciences | Trial completion date: Oct 2024 ➔ Jul 2025 | Initiation date: Aug 2023 ➔ Jan 2024 | Trial primary completion date: Jun 2024 ➔ Jul 2025

Trial completion date • Trial initiation date • Trial primary completion date • Sarcopenia

Intramuscularly injected long-acting testosterone-cholesterol prodrug suspension with three different particle sizes: extended in vitro release and enhanced in vivo safety. (PubMed, Drug Deliv Transl Res) - "The testosterone undecanoate oil solution is the most widely used injection of testosterone for long-acting effects on the market, whereas the formulation carries the potential risk of causing pulmonary vascular embolism, inflammation, and pain at the injection site...Furthermore, the study on pharmacokinetics exhibited that TST-Chol SNCs produced a sustained TST plasma concentration in vivo for up to 40 days and no obvious pathological changes in lung tissue were found. Our study indicated that solubility and particle sizes of suspensions had made a difference in pharmacokinetics and provided a valuable reference for the advancement of long-acting injections."

Journal • Preclinical • Inflammation • Pain

TOTEM-RRMS: TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: University Hospital, Strasbourg, France | Trial completion date: May 2023 ➔ Jan 2027 | Trial primary completion date: May 2023 ➔ Jan 2027

Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

Early Access to Testosterone Therapy in Transgender and Gender-Diverse Adults Seeking Masculinization: A Randomized Clinical Trial. (PubMed, JAMA Netw Open) - "Seven individuals reported injection site pain/discomfort and 1 individual reported a transient headache 24 hours following intramuscular administration of testosterone undecanoate...In this open-label randomized clinical trial of testosterone therapy in transgender and gender-diverse adults, immediate testosterone compared with no treatment significantly reduced gender dysphoria, depression, and suicidality in transgender and gender-diverse individuals desiring testosterone therapy. ANZCTR Identifier: ACTRN1262100016864."

Clinical • Journal • CNS Disorders • Depression • Pain • Psychiatry • Suicidal Ideation