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The Journal of Clinical Endocrinology... Feb 2017Findings of studies of testosterone's effects on muscle strength and physical function in older men have been inconsistent; its effects on muscle power and fatigability... (Randomized Controlled Trial)
Randomized Controlled Trial
CONTEXT
Findings of studies of testosterone's effects on muscle strength and physical function in older men have been inconsistent; its effects on muscle power and fatigability have not been studied.
OBJECTIVE
To determine the effects of testosterone administration for 3 years in older men on muscle strength, power, fatigability, and physical function.
DESIGN, SETTING, AND PARTICIPANTS
This was a double-blind, placebo-controlled, randomized trial of healthy men ≥60 years old with total testosterone levels of 100 to 400 ng/dL or free testosterone levels <50 pg/mL.
INTERVENTIONS
Random assignment to 7.5 g of 1% testosterone or placebo gel daily for 3 years.
OUTCOME MEASURES
Loaded and unloaded stair-climbing power, muscle strength, power, and fatigability in leg press and chest press exercises, and lean mass at baseline, 6, 18, and 36 months.
RESULTS
The groups were similar at baseline. Testosterone administration for 3 years was associated with significantly greater performance in unloaded and loaded stair-climbing power than placebo (mean estimated between-group difference, 10.7 W [95% confidence interval (CI), -4.0 to 25.5], P = 0.026; and 22.4 W [95% CI, 4.6 to 40.3], P = 0.027), respectively. Changes in chest-press strength (estimated mean difference, 16.3 N; 95% CI, 5.5 to 27.1; P < 0.001) and power (mean difference 22.5 W; 95% CI, 7.5 to 37.5; P < 0.001), and leg-press power were significantly greater in men randomized to testosterone than in those randomized to placebo. Lean body mass significantly increased more in the testosterone group.
CONCLUSION
Compared with placebo, testosterone replacement in older men for 3 years was associated with modest but significantly greater improvements in stair-climbing power, muscle mass, and power. Clinical meaningfulness of these treatment effects and their impact on disability in older adults with functional limitations remains to be studied.
Topics: Aged; Aging; Body Composition; Body Mass Index; Double-Blind Method; Hormone Replacement Therapy; Humans; Male; Middle Aged; Muscle Strength; Muscle, Skeletal; Outcome Assessment, Health Care; Physical Fitness; Testosterone
PubMed: 27754805
DOI: 10.1210/jc.2016-2771 -
Methodist DeBakey Cardiovascular Journal 2017Testosterone (T) has a number of important effects on the cardiovascular system. In men, T levels begin to decrease after age 40, and this decrease has been associated... (Review)
Review
Testosterone (T) has a number of important effects on the cardiovascular system. In men, T levels begin to decrease after age 40, and this decrease has been associated with an increase in all-cause mortality and cardiovascular (CV) risk. Low T levels in men may increase their risk of developing coronary artery disease (CAD), metabolic syndrome, and type 2 diabetes. Reduced T levels in men with congestive heart failure (CHF) portends a poor prognosis and is associated with increased mortality. Studies have reported a reduced CV risk with higher endogenous T concentration, improvement of known CV risk factors with T therapy, and reduced mortality in T-deficient men who underwent T replacement therapy versus untreated men. Testosterone replacement therapy (TRT) has been shown to improve myocardial ischemia in men with CAD, improve exercise capacity in patients with CHF, and improve serum glucose levels, HbA1c, and insulin resistance in men with diabetes and prediabetes. There are no large long-term, placebo-controlled, randomized clinical trials to provide definitive conclusions about TRT and CV risk. However, there currently is no credible evidence that T therapy increases CV risk and substantial evidence that it does not. In fact, existing data suggests that T therapy may offer CV benefits to men.
Topics: Cardiovascular Diseases; Cardiovascular System; Female; Hormone Replacement Therapy; Humans; Male; Recovery of Function; Risk Factors; Testosterone; Treatment Outcome
PubMed: 28740585
DOI: 10.14797/mdcj-13-2-68 -
The Canadian Journal of Urology Aug 2020Over the past decade, there have been concerns with safety of testosterone therapy (TTh) in hypogonadal men. Several concerns have centered on the use of TTh and its... (Review)
Review
INTRODUCTION
Over the past decade, there have been concerns with safety of testosterone therapy (TTh) in hypogonadal men. Several concerns have centered on the use of TTh and its potential link to cardiovascular (CV) events, prostate cancer, and benign prostatic hyperplasia (BPH). There has also been controversy in determining which patients are appropriate candidates for TTh and if lifestyle modification has any role in improving serum testosterone values in hypogonadal men.
MATERIALS AND METHODS
A literature review of all articles assessing testosterone and the use of TTh and the association with CV events, prostate cancer, BPH and lifestyle modification was conducted.
RESULTS
Majority of patients treated with TTh today are treated off-label. Low serum testosterone levels have been associated with increased CV events. Currently, there is inconclusive evidence to support that TTh increases the risk of CV events. There is an absence of evidence linking TTh to the development of prostate cancer or worsening of BPH symptoms. Finally, lifestyle modification, such as decreasing weight and improving sleep, can improve serum testosterone levels in hypogonadal men.
CONCLUSIONS
Clinicians prescribing testosterone should be aware of the current controversies associated with TTh. The current literature does not suggest that there is a significant risk with TTh and prostate cancer, worsening of BPH symptoms or CV events. However, more studies, including randomized placebo-controlled trials, are needed. Finally, patients should be counseled appropriately regarding the indications for TTh and the benefits of lifestyle modification prior to initiating TTh.
Topics: Humans; Hypogonadism; Male; Testosterone
PubMed: 32875998
DOI: No ID Found -
Sheng Li Xue Bao : [Acta Physiologica... Dec 2002The purpose of this study was to determine the changes in sex hormone level in men after ejaculation. The serum testosterone concentrations of 28 male volunteers were...
The purpose of this study was to determine the changes in sex hormone level in men after ejaculation. The serum testosterone concentrations of 28 male volunteers were investigated daily during abstinence period after ejaculation. We found that fluctuations of testosterone levels from day 2 to day 5 of abstinence were minimal. On day 7 of abstinence, a peak of serum testosterone appeared, reaching 145.7% of the baseline (P<0.01). After the peak, no regular fluctuation was observed. Ejaculation was the premise and beginning of the 7 days' periodic phenomenon. If there was no ejaculation, there was no periodical changes in serum testosterone level. These results indicate that the periodic change in serum testosterone level is caused by ejaculation.
Topics: Adult; Ejaculation; Humans; Male; Middle Aged; Periodicity; Testosterone
PubMed: 12506329
DOI: No ID Found -
Turk Kardiyoloji Dernegi Arsivi : Turk... Oct 2017A low testosterone level and hypogonadism are associated with cardiovascular disease. Aging, chronic health problems, and obesity are all associated with a low... (Review)
Review
A low testosterone level and hypogonadism are associated with cardiovascular disease. Aging, chronic health problems, and obesity are all associated with a low testosterone level as well as the presence and severity of cardiovascular disease. Testosterone is increasingly prescribed for patients with clinical hypogonadism and a low testosterone level. The information we have is still contradictory regarding testosterone replacement therapy (TRT) and its association with adverse cardiovascular events. Older patients and patients who are susceptible to cardiovascular diseases could be at risk with a testosterone prescription. This is a review of the literature to discuss the cardiovascular safety of TRT.
Topics: Aging; Cardiovascular Diseases; Hormone Replacement Therapy; Humans; Hypogonadism; Male; Testosterone
PubMed: 28990951
DOI: 10.5543/tkda.2017.00531 -
Sexual Medicine Reviews Jan 2018A rapid increase in awareness of androgen deficiency has led to substantial increases in prescribing of testosterone therapy (TTh), with benefits of improvements in... (Review)
Review
INTRODUCTION
A rapid increase in awareness of androgen deficiency has led to substantial increases in prescribing of testosterone therapy (TTh), with benefits of improvements in mood, libido, bone density, muscle mass, body composition, energy, and cognition. However, TTh can be limited by its side effects, particularly erythrocytosis. This review examines the literature on testosterone-induced erythrocytosis and polycythemia.
AIM
To review the available literature on testosterone-induced erythrocytosis, discuss possible mechanisms for pathophysiology, determine the significance of formulation, and elucidate potential thromboembolic risk.
METHODS
A literature review was performed using PubMed for articles addressing TTh, erythrocytosis, and polycythemia.
MAIN OUTCOME MEASURES
Mechanism, pharmacologic contribution, and risk of testosterone-induced erythrocytosis.
RESULTS
For men undergoing TTh, the risk of developing erythrocytosis compared with controls is well established, with short-acting injectable formulations having the highest associated incidence. Potential mechanisms explaining the relation between TTh and erythrocytosis include the role of hepcidin, iron sequestration and turnover, erythropoietin production, bone marrow stimulation, and genetic factors. High blood viscosity increases the risk for potential vascular complications involving the coronary, cerebrovascular, and peripheral vascular circulations, although there is limited evidence supporting a relation between TTh and vascular complications.
CONCLUSION
Short-acting injectable testosterone is associated with greater risk of erythrocytosis compared with other formulations. The mechanism of the pathophysiology and its role on thromboembolic events remain unclear, although some data support an increased risk of cardiovascular events resulting from testosterone-induced erythrocytosis. Ohlander SJ, Varghese B, Pastuszak AW. Erythrocytosis Following Testosterone Therapy. Sex Med Rev 2018;6:77-85.
Topics: Androgens; Hormone Replacement Therapy; Humans; Hypogonadism; Male; Men's Health; Polycythemia; Testosterone
PubMed: 28526632
DOI: 10.1016/j.sxmr.2017.04.001 -
Asian Journal of Andrology 2015The use of testosterone to treat the symptoms of late-onset hypogonadal men has increased recently due to patient and physician awareness. However, concerns regarding... (Review)
Review
The use of testosterone to treat the symptoms of late-onset hypogonadal men has increased recently due to patient and physician awareness. However, concerns regarding the effect of testosterone on the prostate, in particular any possible effect on the risk of prostate cancer have prompted further research in this regard. Surprisingly, numerous retrospective or small, randomized trials have pointed to a possible improvement in male lower urinary tract symptoms (LUTS) in patients treated with testosterone. The exact mechanism of this improvement is still debated but may have a close relationship to metabolic syndrome. For the clinician, the results of these studies are promising but do not constitute high levels of evidence. A thorough clinical examination (including history, examination and laboratory testing of testosterone) should be undertaken before considering the diagnosis of late-onset hypogonadism or instigating treatment for it. Warnings still remain on the testosterone supplement product labels regarding the risk of urinary retention and worsening LUTS, and these should be explained to patients.
Topics: Age Factors; Eunuchism; Hormone Replacement Therapy; Humans; Lower Urinary Tract Symptoms; Male; Prostatic Hyperplasia; Quality of Life; Risk Factors; Testosterone; Treatment Outcome; Urinary Bladder Neck Obstruction
PubMed: 25337845
DOI: 10.4103/1008-682X.140966 -
Bioanalysis Feb 2022The purpose of the study was to find methods suitable for measuring the free concentrations of testosterone and phenytoin. Sample solutions of the compounds in buffer...
The purpose of the study was to find methods suitable for measuring the free concentrations of testosterone and phenytoin. Sample solutions of the compounds in buffer and human albumin were processed using liquid-liquid extraction, microextraction and ultrafiltration and analyzed by LC-MS/MS. Liquid-liquid extraction with dibutyl phthalate provided complete extraction from buffer solutions and partial extraction from albumin samples. Spintip C18 devices provided exhaustive extraction from buffer and albumin samples. Spintip C8 devices offered complete extraction from buffer and approximately 50% recovery from albumin samples. Centrifree ultrafiltration devices showed high recovery of free concentrations from all the samples, while Amicon and Nanosep devices provided partial recovery. Spintip C8 and Centrifree devices proved useful for measuring free concentrations.
Topics: Humans; Liquid Phase Microextraction; Liquid-Liquid Extraction; Phenytoin; Testosterone; Ultrafiltration
PubMed: 35034505
DOI: 10.4155/bio-2021-0249 -
Asian Journal of Andrology 2021Testosterone exerts an important regulation of cardiovascular function through genomic and nongenomic pathways. It produces several changes in cardiomyocytes, the main... (Review)
Review
Testosterone exerts an important regulation of cardiovascular function through genomic and nongenomic pathways. It produces several changes in cardiomyocytes, the main actor of cardiomyopathies, which are characterized by pathological remodeling, eventually leading to heart failure. Testosterone is involved in contractility, in the energy metabolism of myocardial cells, apoptosis, and the remodeling process. In myocarditis, testosterone directly promotes the type of inflammation that leads to fibrosis, and influences viremia with virus localization. At the same time, testosterone exerts cardioprotective effects that have been observed in different studies. There is increasing evidence that low endogenous levels of testosterone have a negative impact in some cardiomyopathies and a protective impact in others. This review focuses on the interrelationships between testosterone and cardiomyopathies and heart failure.
Topics: Cardiomyopathies; Heart Failure; Humans; Testosterone
PubMed: 33433530
DOI: 10.4103/aja.aja_80_20 -
Andrology Nov 2020This manuscript is a review and discussion of the published results of the T Trials. (Review)
Review
BACKGROUND
This manuscript is a review and discussion of the published results of the T Trials.
OBJECTIVE
To re-examine the efficacy of testosterone replacement of hypogonadal men >65 years of age in the T Trials.
MATERIALS AND METHODS
The T Trials were a complex collection of seven double blind, placebo-controlled trials of the efficacy of testosterone as replacement therapy for older men with unequivocal hypogonadism. There were three main trials (sexual function; physical function; vitality) and four sub-trials (cognition; bone; anemia; and cardiovascular). All subjects participated in the main trials while more selective inclusion/exclusion criteria existed for the sub-trials. Subjects were excluded for perceived higher risk of prostate cancer and recent myocardial or cerebral vascular events.
RESULTS
The previously published results are reviewed here as seen in the context of this special issue on late-onset hypogonadism. In the T Trials, positive benefits were seen in the sexual function, bone, and anemia trials with small but significant benefits in the vitality trial. No benefit was seen in the cognition trial, partial benefit in physical function, and a negative benefit outcome seen in the cardiovascular trial. The later trial was underpowered and the results were described as exploratory. Adverse events were relatively uncommon in the 12-month treatment phase and additional 12-month post-treatment phase. The most frequent adverse effect ascribed to testosterone was erythrocytosis.
CONCLUSIONS
The T Trials studied the efficacy of testosterone replacement therapy on 788 men with low testosterone and symptoms of hypogonadism. The studies demonstrated benefits in four trials (sexual function, vitality, bone, and anemia); partial benefit in the physical function trial; no effect in the cognition trial; and a negative effect in the exploratory cardiovascular trial. The T Trials were not designed to assess long-term risks of testosterone in men.
Topics: Age of Onset; Biomarkers; Controlled Clinical Trials as Topic; Hormone Replacement Therapy; Humans; Hypogonadism; Male; Testosterone; Time Factors; Treatment Outcome
PubMed: 32902162
DOI: 10.1111/andr.12901