Testosterone Replacement Therapy: A Narrative Review with a Focus on New Oral Formulations

Bhat, Salman Z; Dobs, Adrian S.

doi:10.17925/ee.2022.18.2.133

Cited by 9 publications

(5 citation statements)

References 53 publications

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“…Both TU preparations demonstrated eugonadal steady 24-hour average serum T levels in more than 80% of hypogonadal patients. In addition, hypogonadism-related sexual symptoms were improved with both preparations [61][62][63][64]. Besides the expected increase in hematocrit (see before), both TU preparations were associated with mild and transient gastrointestinal side effects and, more importantly, with a 3-5 mmHg increase in systolic blood pressure (BP).…”

Section: Possible Solutions With Available or In Development T Prepar...mentioning

confidence: 80%

“…SEEDS strategy allows absorption of TU during a regular meal without the necessity of a high-fat one. The results of clinical trials with these two TU formulations have been recently reviewed elsewhere [61][62][63][64]. JATENZO is available in three dosing formulations (158, 198, and 237 mg) that should be taken b.i.d.…”

Section: Possible Solutions With Available or In Development T Prepar...mentioning

confidence: 99%

“…One more recent meta-analysis of randomized placebo-controlled TRT trials (including individual participant data sets) suggests that the percentage of treated subjects with hypertension is similar in the two arms [69]. One possible explanation is that in the most recent trials involving oral TU, the regulatory authorities required more stringent and sensitive measurements of BP parameters, including ambulatory BP monitoring, than in the past [61,63].…”

Section: Possible Solutions With Available or In Development T Prepar...mentioning

confidence: 99%

See 2 more Smart Citations

Developments and challenges for new and emergent preparations for male hypogonadism treatment

Corona,

Sparano,

Rastrelli

et al. 2023

Expert Opinion on Investigational Drugs

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Introduction:The specific role of testosterone (T) replacement therapy in patients with late onset hypogonadism is still conflicting. Several available preparations have been developed to restore either fertility and normal testosterone (T) levels (secondary hypogonadism) or just T levels (primary hypogonadism). Areas covered: Advantages and limitations related to available new treatments will be discussed in detail. In addition, possible news related to preparations in the pipeline will be discussed. Expert opinion:The selection of a specific T preparation should be adequately discussed with each subject. Transdermal T preparations are those that can preserve, after a unique morning administration, the circadian rhythmicity of T secretion. Conversely, short-acting preparations (such as oral or intranasal) need two-or threetimes daily administration, potentially reducing patient compliance. Long acting T preparations, such as injectable T undecanoate have the advantage of bimestrial or trimestral administration, reducing the required number of administrations. The use of non-steroidal selective androgen receptor modulators (SARM), a heterogeneous class of compounds selectively acting on androgen receptor targets, remains investigational due to the lack of the full spectrum of T's action and the possible risk of side effects, despite their potential use in the treatment of muscle wasting and osteoporosis.

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Section: Possible Solutions With Available or In Development T Prepar...mentioning

confidence: 80%

Section: Possible Solutions With Available or In Development T Prepar...mentioning

confidence: 99%

Section: Possible Solutions With Available or In Development T Prepar...mentioning

confidence: 99%

See 1 more Smart Citation

Developments and challenges for new and emergent preparations for male hypogonadism treatment

Corona,

Sparano,

Rastrelli

et al. 2023

Expert Opinion on Investigational Drugs

View full text Add to dashboard Cite

show abstract

“…In Japan, the most common method of TRT is intramuscular administration, although OTC ointment formulations are also available. Overseas, administration routes include oral and transmucosal (transnasal) as well as intramuscular and transdermal [25].…”

Section: Trt Methods and Side Effectsmentioning

confidence: 99%

The impact of testosterone in men’s health

Ide

2023

Endocr J

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Testosterone plays a key role in the maintenance of physical and mental functions in men. Age-related testosterone decline is closely associated with sarcopenia and muscle deterioration, while testosterone decline is linked with the etiology and prevention of diseases such as angina pectoris, arteriosclerosis, obesity, metabolic syndrome, and dementia. Late-onset hypogonadism (LOH) is defined as a disease characterized by age-related testosterone decline and associated clinical symptoms. Testosterone replacement therapy improves health-related QOL in patients with LOH.

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“…Clinically, the primary goal of TRT is to restore normal testosterone levels in response to testosterone deficiency, rather than to elevate testosterone levels. Testosterone supplements used for TRT are available in several different formulations [ 13 , 14 ]. However, the drugs themselves are steroid hormones and carry the potential risk of side effects [ 15 , 16 ].…”

Section: Introductionmentioning

confidence: 99%

Ameliorative effects of elderberry (Sambucus nigra L.) extract and extract-derived monosaccharide-amino acid on H2O2-induced decrease in testosterone-deficiency syndrome in a TM3 Leydig cell

Lee,

Kim,

Kong

et al. 2024

PLoS ONE

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With aging, men develop testosterone-deficiency syndrome (TDS). The development is closely associated with age-related mitochondrial dysfunction of Leydig cell and oxidative stress-induced reactive oxygen species (ROS). Testosterone-replacement therapy (TRT) is used to improve the symptoms of TDS. However, due to its various side effects, research on functional ingredients derived from natural products that do not have side effects is urgently needed. In this study, using the mitochondrial dysfunction TM3 (mouse Leydig) cells, in which testosterone biosynthesis is reduced by H2O2, we evaluated the effects of elderberry extract and monosaccharide-amino acid (fructose–leucine; FL) on mRNA and protein levels related to steroidogenesis-related enzymes steroidogenic acute regulatory protein (StAR), cytochrome P450 11A1(CYP11A1, cytochrome P450 17A1(CYP17A1), cytochrome P450 19A1(CYP19A1, aromatase), 3β-hydroxysteroid dehydrogenase (3β-HSD), and 17β-hydroxysteroid dehydrogenase(17β-HSD). We analyzed elderberry extract and extract-derived FL for changes in ROS scavenging activity and testosterone secretion. Elderberry extract and FL significantly reduced H2O2-induced intracellular ROS levels, improved testosterone secretion, and increased the mRNA and protein expression levels of steroidogenesis-related enzymes (StAR, 3b-HSD, 17b-HSD, CYP11A1, CYp17A1). However, the conversion of testosterone to estradiol was inhibited by elderberry extract and extract-derived FL, which reduced the mRNA and protein expression of CYP19A1. In conclusion, elderberry extract and FL are predicted to have value as novel functional ingredients that may contribute to the prevention of TDS by ameliorating reduced steroidogenesis.

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Testosterone Replacement Therapy: A Narrative Review with a Focus on New Oral Formulations

Cited by 9 publications

References 53 publications

Developments and challenges for new and emergent preparations for male hypogonadism treatment

Developments and challenges for new and emergent preparations for male hypogonadism treatment

The impact of testosterone in men’s health

Ameliorative effects of elderberry (Sambucus nigra L.) extract and extract-derived monosaccharide-amino acid on H2O2-induced decrease in testosterone-deficiency syndrome in a TM3 Leydig cell

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