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In a randomized trial involving men with hypogonadism and preexisting or a risk of cardiovascular disease, testosterone therapy was noninferior to placebo with respect to major adverse cardiac events.

In this study, men 65 years of age or older with low serum testosterone and symptoms of hypoandrogenism received testosterone or placebo for a year. Testosterone had a moderate benefit in sexual function and some benefit in mood but no benefit in vitality or walking distance. Testosterone concentrations in men decrease with increasing age. 1 , 2 Many symptoms and conditions similar to those that are caused by low testosterone levels in men with pituitary or testicular disease become more common with increasing age. Such symptoms include decreases in mobility, sexual function, and energy. These parallels suggest that the lower testosterone levels in older men may contribute to these conditions. Previous trials of testosterone treatment in men 65 years of age or older, however, have yielded equivocal results. Although testosterone treatment consistently increased muscle mass and decreased fat mass, 3 , 4 effects on physical performance, 3 , 5 , 6 sexual function, . . .

In this subtrial involving middle-aged and older men with hypogonadism, testosterone treatment did not result in a lower incidence of clinical fracture than placebo. Fracture incidence was numerically higher with testosterone.

This study, designed to determine the relative degree of testosterone deficiency, estradiol deficiency, or both at which undesirable bodily changes occur, showed that some features of male hypogonadism are due to both androgen deficiency and estrogen deficiency. Testosterone therapy is prescribed for millions of men each year, and the number is increasing rapidly. Prescription sales of testosterone increased by 500% in the United States between 1993 and 2000. 1 Most testosterone prescriptions are written to treat nonspecific symptoms, such as fatigue or sexual dysfunction, when accompanied by testosterone levels below the laboratory reference range. Currently, testosterone levels that are at least 2 SD below the mean value for healthy young adults are classified as low. 1 , 2 Although convenient, this classification fails to consider the physiological consequences of specific testosterone levels. More than 80% of circulating estradiol in men . . .

In a randomized trial, men 65 years of age or older who had low serum testosterone levels and limitations in mobility were assigned to either placebo or testosterone gel to be applied daily for 6 months. The primary end point was improvement in leg-press strength, which was greater with testosterone therapy than with placebo. However, the trial was stopped early because of a greater number of cardiac adverse events in the testosterone group. In men 65 years of age or older with low serum testosterone levels and limitations in mobility, improvement in leg-press strength was greater with testosterone therapy than with placebo. However, there were more cardiac adverse events in the testosterone group. Limited mobility is a common geriatric condition that is a predictor of disability, poor quality of life, and death. 1 – 7 In men, an age-related decline in the serum testosterone concentration is associated with reduced muscle mass and lower-extremity strength, limitations in physical function, and poor mobility. 8 – 13 Testosterone supplementation increases muscle mass and strength and leg power, all of which are important determinants of mobility. 14 – 21 Previous trials of testosterone supplementation have been conducted primarily among healthy older men. The safety and efficacy of testosterone treatment in improving muscle performance and physical function in older men with limitations in mobility . . .

Luteinizing hormone–releasing hormone agonists that are used in androgen-deprivation therapy have a slow onset to suppress testosterone levels, and the level of suppression may be incomplete. This randomized trial assessed relugolix, an oral gonadotropin-releasing hormone antagonist with rapid onset, profound suppression of testosterone levels, and rapid recovery after cessation.

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.Testosterone replacement in older men for 3 years was associated with modest but significantly greater improvements in muscle power and physical function compared with placebo.

Abstract Context Studies of the possible cardiovascular risk of testosterone treatment are inconclusive. Objective To determine the effect of testosterone treatment on cardiovascular biomarkers in older men with low testosterone. Design Double-blind, placebo-controlled trial. Setting Twelve academic medical centers in the United States. Participants In all, 788 men ≥65 years old with an average of two serum testosterone levels <275 ng/dL who were enrolled in The Testosterone Trials. Intervention Testosterone gel, the dose adjusted to maintain the testosterone level in the normal range for young men, or placebo gel for 12 months. Main Outcome Measures Serum markers of cardiovascular risk, including lipids and markers of glucose metabolism, fibrinolysis, inflammation, and myocardial damage. Results Compared with placebo, testosterone treatment significantly decreased total cholesterol (adjusted mean difference, −6.1 mg/dL; P < 0.001), high-density lipoprotein cholesterol (adjusted mean difference, −2.0 mg/dL; P < 0.001), and low-density lipoprotein cholesterol (adjusted mean difference, −2.3 mg/dL; P = 0.051) from baseline to month 12. Testosterone also slightly but significantly decreased fasting insulin (adjusted mean difference, −1.7 µIU/mL; P = 0.02) and homeostatic model assessment‒insulin resistance (adjusted mean difference, −0.6; P = 0.03). Testosterone did not change triglycerides, d-dimer, C-reactive protein, interleukin 6, troponin, glucose, or hemoglobin A1c levels more than placebo. Conclusions and Relevance Testosterone treatment of 1 year in older men with low testosterone was associated with small reductions in cholesterol and insulin but not with other glucose markers, markers of inflammation or fibrinolysis, or troponin. The clinical importance of these findings is unclear and requires a larger trial of clinical outcomes. Compared with placebo, testosterone treatment of older men with low testosterone was associated with small reductions in total, HDL, and LDL cholesterol and in insulin and HOMA-IR but not glucose.

Androgen-deprivation therapy for prostate cancer has side effects. In this study, intermittent androgen-deprivation therapy was associated with a survival rate similar to that with continuous treatment, with about one third the total antiandrogen exposure and fewer side effects. Ever since Huggins and Hodges's work of 1941 1 showing the androgen dependence of prostate cancer, androgen deprivation has been the mainstay treatment for metastatic disease. With the development of reversible forms of medical castration, indications for androgen deprivation have been expanded to include nonmetastatic disease. 2 – 4 The introduction of prostate-specific antigen (PSA) testing into clinical practice in the early 1990s provided an objective evaluation of the efficacy of definitive treatment; biochemical failure became an accepted end point. The ability to diagnose early treatment failure created a clinical dilemma. The justification for lifelong androgen deprivation is more apparent in the case . . .

Background: Ketogenic diet (KD) is a nutritional approach that restricts daily carbohydrates, replacing most of the reduced energy with fat, while maintaining an adequate quantity of protein. Despite the widespread use of KD in weight loss in athletes, there are still many concerns about its use in sports requiring muscle mass accrual. Thus, the present study sought to investigate the influence of a KD in competitive natural body builders. Methods: Nineteen volunteers (27.4 ± 10.5 years) were randomly assigned to ketogenic diet (KD) or to a western diet (WD). Body composition, muscle strength and basal metabolic rate were measured before and after two months of intervention. Standard blood biochemistry, testosterone, IGF-1, brain-derived neurotrophic factor (BDNF) and inflammatory cytokines (IL6, IL1β, TNFα) were also measured. Results: Body fat significantly decreased in KD (p = 0.030); whilst lean mass increased significantly only in WD (p < 0.001). Maximal strength increased similarly in both groups. KD showed a significant decrease of blood triglycerides (p < 0.001), glucose (p = 0.001), insulin (p < 0.001) and inflammatory cytokines compared to WD whilst BDNF increased in both groups with significant greater changes in KD (p < 0.001). Conclusions: KD may be used during body building preparation for health and leaning purposes but with the caution that hypertrophic muscle response could be blunted.