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Abstract Background Elevated serum levels of luteinizing hormone and slightly decreased serum levels of testosterone (mild Leydig cell insufficiency) is a common hormonal disturbance in testicular cancer (TC) survivors. A number of studies have shown that low serum levels of testosterone is associated with low grade inflammation and increased risk of metabolic syndrome. However, so far, no studies have evaluated whether testosterone substitution improves metabolic dysfunction in TC survivors with mild Leydig cell insufficiency. Methods/design This is a single-center, randomized, double-blind, placebo-controlled study, designed to evaluate the effect of testosterone replacement therapy in TC survivors with mild Leydig cell insufficiency. Seventy subjects will be randomized to receive either testosterone replacement therapy or placebo. The subjects will be invited for an information meeting where informed consent will be obtained. Afterwards, a 52-weeks treatment period begins in which study participants will receive a daily dose of transdermal testosterone or placebo. Dose adjustment will be made three times during the initial 8 weeks of the study to a maximal daily dose of 40 mg of testosterone in the intervention arm. Evaluation of primary and secondary endpoints will be performed at baseline, 26 weeks post-randomization, at the end of treatment (52 weeks) and 3 months after completion of treatment (week 64). Discussion This study is the first to investigate the effect of testosterone substitution in testicular cancer survivors with mild Leydig cell insufficiency. If positive, it may change the clinical handling of testicular cancer survivors with borderline low levels of testosterone. Trial registration ClinicalTrials.gov : NCT02991209 (November 25, 2016).

Background: Elevated serum levels of luteinizing hormone and slightly decreased serum levels of testosterone (mild Leydig cell insufficiency) is a common hormonal disturbance in testicular cancer (TC) survivors. A number of studies have shown that low serum levels of testosterone is associated with low grade inflammation and increased risk of metabolic syndrome. However, so far, no studies have evaluated whether testosterone substitution improves metabolic dysfunction in TC survivors with mild Leydig cell insufficiency.Methods/design: This is a single-center, randomized, double-blind, placebo-controlled study, designed to evaluate the effect of testosterone replacement therapy in TC survivors with mild Leydig cell insufficiency. Seventy subjects will be randomized to receive either testosterone replacement therapy or placebo. The subjects will be invited for an information meeting where informed consent will be obtained. Afterwards, a 52-weeks treatment period begins in which study participants will receive a daily dose of transdermal testosterone or placebo. Dose adjustment will be made three times during the initial 8 weeks of the study to a maximal daily dose of 40 mg of testosterone in the intervention arm. Evaluation of primary and secondary endpoints will be performed at baseline, 26 weeks post-randomization, at the end of treatment (52 weeks) and 3 months after completion of treatment (week 64).Discussion: This study is the first to investigate the effect of testosterone substitution in testicular cancer survivors with mild Leydig cell insufficiency. If positive, it may change the clinical handling of testicular cancer survivors with borderline low levels of testosterone.Trial Registration: ClinicalTrials.gov : NCT02991209 (November 25, 2016). [ABSTRACT FROM AUTHOR]

All forms of hypogonadism – primary, secondary and late-onset – require testosterone substitution. The indication is given when the patient presents with symptoms of androgen deficiency and the serum testosterone levels are below normal. Several testosterone preparations and modes of application are available of which those producing physiologic serum levels should be preferred e.g. preferentially transdermal gels and long-acting intramuscular testosterone undecanoate. Testosterone substitution must be monitored at regular intervals, best at 3, 6 and 12 months after initiation and then annually. Parameters for surveillance include well-being, libido and sexual activity, measurement of serum testosterone levels, haemoglobin and haematocrit, PSA and digital rectal examination, and, biannually, bone mineral density. Testosterone has positive effects on comorbidities such as obesity, metabolic syndrome, diabetes type II, cardiovascular diseases and osteoporosis. [ABSTRACT FROM AUTHOR]

Abstract: Testosterone substitution is reported to produce a wide range of benefits for men with hypogonadism that include improvements in muscle mass, body composition, mood, bone density, libido, and cognition. Understanding the actions of exogenous testosterone on the prostate gland is important since testosterone is the major regulator of growth and function of this organ. To date, clinical studies of the effects of testosterone substitution on prostate health suggest that testosterone substitution does not exacerbate lower urinary tract symptoms (LUTS) attributable to benign prostatic hyperplasia (BPH), although it may increase prostate volume. The greatest concern associated with testosterone substitution is the possibility of increased risk of prostate cancer. The relationship between prostate cancer and testosterone is not completely understood. While there is currently no compelling evidence that the use of testosterone substitution in men with hypogonadism increases the risk of prostate cancer, close monitoring of the levels of testosterone and prostate-specific antigen (PSA) along with regular digital rectal examination (DRE) are advised to detect early signs of prostate cancer in subjects receiving long-term testosterone substitution. This review considers the physiological and pharmacological actions of testosterone on the prostate gland, and the risks of BPH and prostate cancer in ageing males receiving testosterone substitution for the treatment of hypogonadism. [Copyright &y& Elsevier]

Copyright of Der Urologe A is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Der Urologe A is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Der Urologe A is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Abstract: As a background to the satellite symposium held during the XXth Congress of the European Association of Urology on 17 March 2005 in Istanbul, Turkey, entitled “Would you recognize LOH if it walked into your practice? Diagnosis and management of late-onset hypogonadism”, the history of testosterone substitution was summarized. In the 18th, 19th, and early 20th centuries, physicians such as Hunter, Brown-Séquard, Steinach, and Voronoff paved the way for later researchers by reporting various testicular grafting and transplantation experiments. It was not until the 1930s, however, that testosterone, the primary androgen responsible for male physiology and behaviour, was biochemically identified, and then chemically synthesized by 3 separate research groups: Butenandt, Ruzicka, and Laqueur. This marked the beginning of a new era in men''s health, from which our present understanding of the role of testosterone stems. Since then, late-onset hypogonadism has come to be understood as a medical condition that may warrant treatment, and modern formulations of testosterone offer a substantial improvement over earlier formulations. [Copyright &y& Elsevier]

Background: Compensated Leydig cell (LC) dysfunction, defined by elevated serum levels of luteinizing hormone (LH) in combination with normal total testosterone levels, is common in testicular cancer (TC) survivors. The association between this condition and quality of life is unknown. We aimed to clarify if TC survivors with compensated LC dysfunction have impaired quality of life., Patients and Methods: In total, 147 long-term TC survivors were included. On the basis of a single measurement of testosterone and LH, compensated LC dysfunction was defined by age-adjusted levels of LH above normal range combined with testosterone levels within the normal range. Quality-of-life outcomes including sexual function, anxiety and depression, fatigue, and overall self-evaluated quality of life were compared between patients with and without compensated LC dysfunction with adjustment for age., Results: In total, 60 TC survivors had compensated LC dysfunction and 87 TC survivors had normal LC function. TC survivors with compensated LC dysfunction had lower serum levels of total testosterone (11 vs. 13 nmol/L, P = .016). There were no significant differences in the investigated quality-of-life outcomes (anxiety, depression, sexual function, fatigue) between the 2 groups., Conclusion: Compensated LC dysfunction in TC survivors was not associated with symptoms of depression, anxiety, sexual dysfunction, fatigue, or impaired overall self-evaluated quality of life. Limitations include the few cases of symptoms of depression (n = 7). Our findings do not suggest that testosterone substitution is indicated in TC survivors with compensated LC dysfunction., (Copyright © 2018 Elsevier Inc. All rights reserved.)