Guideline for Male Testosterone Therapy: A Regulatory Perspective

Shames, Daniel; Gassman, Audrey; Handelsman, H

doi:10.1210/jc.2006-2642

Cited by 13 publications

(4 citation statements)

References 3 publications

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“…A number of studies have demonstrated the beneficial effects of TRT on various unfavorable symptoms in men diagnosed with LOH without severe adverse events related to this therapy. Thus, TRT has become the mainstay of treatment for aging men with testosterone deficiency who exhibit clinical signs associated with hypogonadism (Mäkinen & Huhtaniemi, 2011; Shames, Gassman, & Handelsman, 2007). Some concerns remain regarding the negative effects of TRT on men with LOH, of which the possible deterioration of symptoms associated with BPH is regarded as one of the most considerable events for the following reasons: the onset of LUTS in men occurs at a time in life when testosterone levels begin to decline, and the growth of the prostate gland is closely regulated by testosterone levels (Huggins, & Stevens, 1940; Imperato-McGinley, Guerrero, Gautier, & Peterson, 1974; Oesterling, Epstein, & Walsh, 1986; Wu, & Gu, 1991).…”

Section: Discussionmentioning

confidence: 99%

Improved Lower Urinary Tract Symptoms Associated With Testosterone Replacement Therapy in Japanese Men With Late-Onset Hypogonadism

et al. 2016

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This study aimed to investigate the effects of testosterone replacement therapy (TRT) on lower urinary tract symptoms (LUTS) in men with late-onset hypogonadism (LOH) and to identify parameters predicting the efficacy of TRT in improving LUTS. This study included 60 consecutive Japanese men who were diagnosed with LOH and subsequently received TRT between January 2009 and December 2014. In this series, 250 mg of testosterone was injected intramuscularly every 3 or 4 weeks in all patients. The following parameters were retrospectively reviewed: body mass index (BMI), Aging Male Symptom (AMS) score, International Prostate Symptom Score (IPSS), International Index of Erectile Function-5 (IIEF-5) score, residual urine volume, prostate volume, serum levels of the prostate-specific antigen (PSA), and total- and free-testosterone levels before and 6 months after TRT. No significant differences were observed in BMI, residual urine volume, or prostate volume between surveys before and after TRT. The AMS score, IPSS, and IIEF-5 score were significantly improved and significant increases were noted in the serum levels of PSA and total- and free-testosterone levels after TRT. An analysis of IPSS subscores documented the significant improvement in storage symptom scores, but not in voiding symptom scores after TRT. Multivariate analyses of parameters assessed in this study identified the pretreatment AMS score, posttreatment IIEF-5 score, and prostate volume as independent predictors of improvements in IPSS following TRT. This study revealed that TRT appeared to have considerable therapeutic effects on LUTS, particularly on storage symptoms, in men with LOH.

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Section: Discussionmentioning

confidence: 99%

Improved Lower Urinary Tract Symptoms Associated With Testosterone Replacement Therapy in Japanese Men With Late-Onset Hypogonadism

et al. 2016

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“…4,5 Because of the uncertainty regarding the nature of testosterone deficiency in aging men, 6-9 recent guidelines have suggested that so-called late-onset hypogonadism be regarded as a clinical and biochemical state with advancing age, characterized by particular symptoms and a low level of serum testosterone. 10,11 However, few data on hypogonadism in aging men are available 4,8,12 because of the lack of evidence regarding the exact criteria for identifying testosterone deficiency in older men who do not have pathological hypogonadism. 6,13 Although a familiar array of symptoms typify severe testosterone deficiency (total testosterone level, <6 to 8 nmol per liter [1.7 to 2.3 ng per milliliter]) in younger patients, symptoms in aging men are nonspecific and are mimicked by other prevalent disorders.…”

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confidence: 99%

Identification of Late-Onset Hypogonadism in Middle-Aged and Elderly Men

et al. 2010

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“…In addition, testosterone also reduced total cholesterol, with no change in low density lipoprotein-cholesterol (22). Despite some good results, whether testosterone therapy is beneficial for aging men in preventing or delaying some aspects of ageing is still controversial, and more studies are needed (23,24).…”

Section: Discussionmentioning

confidence: 99%

Age-related testosterone decline in a Brazilian cohort of healthy military men

et al. 2011

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Introduction: Androgen decline in the aging man has become a topic of increasing clinical relevance worldwide, as the reduction in testosterone levels has been reported to be accompanied by loss of muscle mass, accumulation of central adiposity, impaired mobility and increase risk of bone fractures. Although well-established in studies conducted in developed countries, progressive decline in serum testosterone levels with age has been poorly investigated in Brazil. Aim: To determine the pattern of blood testosterone concentrations decline with age in a cohort of Brazilian healthy military men. Materials and Methods:We retrospectively reviewed data on serum testosterone measurements of healthy individuals that had undergone a routine check-up at the Military Biology Institute. Blood samples were obtained early in the morning, and total testosterone concentration was determined using a commercial chemoluminescent immunoassay. Mean values were analyzed in five age groups: ≤ 40, 41 to 50, 51 to 60, 61 to 70, and > 70 years. Main Outcome Measure: Mean total testosterone levels. Results: 1,623 subjects were included in the analysis; mean age was 57 years (24 to 87), and mean testosterone level was 575.5 ng/dL (25.0 to 1308.0 ng/dL). The evaluation of age-related changes in total testosterone levels revealed a progressive reduction in serum levels of this hormone with increasing age. Testosterone levels below 300 ng/dL were reported in 321 participants, a prevalence of nearly 20% in the study population. Conclusion:In agreement with other findings, a reduction of total testosterone levels with age was reported for healthy Brazilian men.

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Guideline for Male Testosterone Therapy: A Regulatory Perspective

Cited by 13 publications

References 3 publications

Improved Lower Urinary Tract Symptoms Associated With Testosterone Replacement Therapy in Japanese Men With Late-Onset Hypogonadism

Improved Lower Urinary Tract Symptoms Associated With Testosterone Replacement Therapy in Japanese Men With Late-Onset Hypogonadism

Identification of Late-Onset Hypogonadism in Middle-Aged and Elderly Men

Age-related testosterone decline in a Brazilian cohort of healthy military men

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