Testosterone therapy should be initiated only after two morning total serum testosterone measurements show decreased levels, and all patients should be counseled on the potential risks and benefits before starting therapy. Although prior studies suggested that testosterone replacement therapy increased the risk of cardiovascular disease, a large, randomized trial showed that it does not increase the risk of myocardial infarction or stroke, even in patients at high risk. Testosterone deficiency, or male hypogonadism, is a clinical syndrome that can be defined as persistently low serum testosterone levels in the setting of symptoms consistent with testosterone deficiency. In men.65 years who have symptoms or conditionssuggestive of testosterone deficiency (such as low libido or unexplained anemia) and consistentlyand unequivocally low morning testosterone concentrations, we suggest that clinicians offertestosterone therapy on an individualized basis after explicit discussion of the potential risks andbenefits.
The literature indicates that men with lower baseline testosterone levels are more likely to experience PSA level increases. In 2013, the AUA published the Early Detection of Prostate Cancer Guideline,222 which makes no specific statements about PSA screening in men with testosterone deficiency or in men on testosterone therapy. If the Hct exceeds 50%, clinicians should consider withholding testosterone therapy until the etiology of the high Hct is explained.187 While on testosterone therapy, a Hct ≥54% warrants intervention.
LH, which is routinely measured by immunoassay, may help to establish the etiology of testosterone deficiency and can be an important factor in determining if adjunctive tests should be ordered (Appendix C - refer to the Appendix C section in the left menu). Their role in diagnosing testosterone deficiency is unclear, and they should not be used at the expense of a full patient evaluation, including laboratory testosterone measurement. Thus, pituitary dysfunction can develop after radiation therapy for sellar, parasellar, and extrasellar neoplasms (e.g., craniopharyngiomas, meningiomas, germinomas, chordomas, hemangio-pericytomas, pituicytomas, gliomas), head and neck tumors, and following total body irradiation for systemic malignancies. In conditions where LH is not produced in normal amounts (hypogonadotropic hypogonadism), testosterone deficiency may also result. With worsening Leydig cell function, there is a reduction in the feedback mechanism resulting in elevation of LH levels (hypergonadotropic hypogonadism). In homeostasis, LH levels are typically low. Pituitary dysfunction may be a significant cause of testosterone deficiency.
Product labels for all testosterone formulations explicitly state that their use is contraindicated in men with a history of prostate cancer, which results from Huggins' precept that testosterone therapy feeds prostate cancer cell proliferation. Given the increasing incidence of both testosterone deficiency and prostate cancer with advancing age, it is common for the two conditions to co-exist in older men. A total of 651 men (mean age 62.9 years) received oral, transdermal, or IM testosterone, while 433 men received placebo for a period of 12 weeks to 36 months.
Given these pharmacologic and mechanistic differences, combinations of these alternative therapies might, in some instances, be clinically appropriate. For this reason, alternative therapies, including SERMs, AIs, and hCG, are commonly used to promote the endogenous production of testosterone. It is unclear if the transferred testosterone remained biologically active.
Removal of the system results in a rapid drop in testosterone levels.433 In the case of topical patches, the testosterone levels achieved directly relate to the amount of surface area exposed to drug.430 Topical gels and liquids generally demonstrate less variability in absorption uptake when compared to other therapies.417 After application, steady state levels are achieved within hours, with testosterone levels returning to baseline within 4 days of discontinuation.418, 419 The current guideline only included studies in the meta-analysis that used morning total testosterone 411 Meta-analyses of RCTs and cohort studies provide the highest levels of evidence and reliability, followed by individual RCTs, prospective cohorts, retrospective cohorts, and observational studies. Thousands of articles on testosterone deficiency and testosterone therapy have been published over the past several decades.
In general, smaller dosages at more frequent intervals are preferred over high, less frequent administrations to limit the duration of time spent outside (above or below) the normal reference range. The optimal dosing strategy has not been defined for short-acting IM testosterone preparations. Mean testosterone values over a 7-day time period were 1,659, 896, and 422 ng/dL for IM testosterone SQ 100, and SQ 50, respectively. The half-life for IM testosterone was also shorter at 173 hours versus 240 hours for SQ testosterone.

Gender: Female

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