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Treating low testosterone levels Similarly, in the event patients have unexplained anemia that improves on testosterone therapy, continuation can be considered even in the absence of other symptom improvement. There is no utility in continuing testosterone therapy in men who achieve target testosterone levels without symptom improvement. If patients achieve target testosterone levels, but do not feel that they have sufficient improvement in their symptoms, clinicians should question whether testosterone deficiency is the etiology of their symptoms. Testing intervals are the expert opinion of the Panel and are provided as a guide to aid clinicians in the follow-up of such patients. This situation commonly occurs as reference laboratories often define a normal value as ranging within the 5th (or 2.5th) and 95th (or 97.5th) percentiles of a sampled population. As an example, a total testosterone value of 250 ng/dL may be considered low based on the current guideline but be marked within the normal range by the laboratory. Due to the challenges in testosterone methodology, there is considerable variability in testosterone reference ranges.13 The specific reference ranges used to diagnose testosterone deficiency are discussed in more depth later in this document. The differences in testosterone methodologies have led to considerable effort by a variety of parties including the Centers for Disease Control (CDC) and the College of American Pathologists towards harmonization of assays. Inter-assay CV measures the agreement between tests using the same method of measurement on identical samples, in the same laboratory, by the same operator using the same equipment within a short interval of time. Within this modality family alone, there are three different application sites, including upper body, thigh, and axilla, with four different dosing ranges for each gel. The explosion in the use of testosterone in the past decade is multifactorial in its etiology, including the increased use of direct-to-consumer advertising, which has resulted in greater patient knowledge and demand; relaxation of the indications for testosterone prescribing by clinicians; and the establishment of clinical care centers devoted to men's health, testosterone treatment, and anti-aging strategies. Clinicians should adjust testosterone therapy dosing to achieve a total testosterone level in the middle tertile of the normal reference range. Patients should be informed that the evidence is inconclusive whether testosterone therapy improves cognitive function, measures of diabetes, energy, fatigue, lipid profiles, and quality of life measures. Prior to offering testosterone therapy, clinicians should measure hemoglobin and hematocrit and inform patients regarding the increased risk of polycythemia. The use of validated questionnaires is not currently recommended to either define which patients are candidates for testosterone therapy or to monitor symptom response in patients on testosterone therapy. Recent studies have explored the association between varicocele and low testosterone levels, and while there is no definitive evidence that varicocele presence is a cause of low testosterone, accumulating data suggest that ligation surgery might increase serum testosterone levels. An analysis of 625 men in the Massachusetts Male Aging Study (MMAS)6 used a single question to define ED and also showed an increase in ED risk as total testosterone levels decreased. A challenge in making the diagnosis of testosterone deficiency is that many of the symptoms reported by patients are non-specific and might be related to conditions other than low testosterone. In a small study of young men with acute respiratory infections, mean total testosterone levels declined by 10%, with some cohorts experiencing reductions of up to 30%.25 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. 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. Injectable testosterone is available in several forms, including short acting and long-acting preparations. In a 90-day open label trial of 306 testosterone deficient men using two actuations (11mg) of the drug applied three times daily, results were reported for 73 men at day 90. The most common adverse effect with patches is application site reactions, which have been historically reported in up to 60% of patients.181 Other adverse effects include pruritus, application site vesicles, and back pain.431 Compared to topical gels and solutions, the rate of transference is likely minimal. Patches are currently available in 2 and 4 mg formulations, with a 4mg starting dose recommended and titration to 6 mg permitted. In the testosterone therapy group, the raw data revealed a 2% myocardial infarction rate and a 3% cerebrovascular accident rate compared to 6% and 6%, respectively, in those patients not receiving testosterone. Two of the retrospective studies included in the FDA review pointed to an increased risk of cardiovascular events in men on testosterone therapy. Two of the trials and one meta-analysis pointed to an increased risk of cardiovascular events,363, 364, 366 two revealed no cardiovascular risk,233, 367 and one was neutral with respect to risk.373 The Corona meta-analysis,372 which showed that there was no increased risk of cardiovascular events, was not officially reviewed but was taken into consideration in the final analysis. The most common chromosomal abnormality identified is 47,XXY, also known as KS, although other chromosomal abnormalities can also be found. Men who are on testosterone therapy should be advised to report the occurrence of any possible cardiovascular symptoms, such as chest pain, shortness of breath, dizziness, or transient loss of consciousness, during routine follow-up visits. The risk corresponded to an additional 10 cases per 10,000 person-years, which, while low in absolute terms, raised concern about using testosterone therapy in men who may be at increased risk for VTE prior to commencement of therapy.362 Conversely, a population-based retrospective case-control study utilizing a UK clinical database of 19,215 patients with confirmed VTE showed that there was increased risk of VTE in the first 6 months of testosterone therapy. The authors of the paper could not attribute the cancer diagnosis to testosterone treatment alone considering prostate cancer develops in as many as one quarter of PIN+ patients within three years. Clinicians should be aware that a period of time should elapse after RT and before initiating testosterone therapy in order to allow the patient adequate time to regain functional endogenous testosterone production. Testosterone therapy can be considered in those men who have undergone radical prostatectomy (RP) with favorable pathology (e.g., negative margins, negative seminal vesicles, negative lymph nodes), and who have undetectable PSA postoperatively. With respect to testosterone specifically, Grober et al. conducted an analysis of compounded testosterone creams/gels from 10 pharmacies in Toronto, Canada.410 Each pharmacy was given two prescriptions for 50 mg of testosterone, separated by 1 month to assess both intra-pharmacy and inter-pharmacy consistency. In contrast to commercial pharmaceutical manufacturing, which is regulated by the FDA, compounded medications are regulated by state laws and, therefore, vary significantly from one region to another.405 While testosterone gels and creams are the most commonly used forms of compounded testosterone therapies and are routinely less expensive than branded forms of testosterone, these preparations by individual pharmacies occur without direct FDA oversight and approval. Liu et al. conducted a double-blind, placebo controlled, randomized trial assessing response to hCG therapy in older men (mean age 67 years) with androgen deficiency.399 The authors found a 150% increase in total testosterone level, which they concluded demonstrates that older males retain "testicular responsiveness" to gonadotropin therapy. Clinicians should understand that of these agents, only hCG has been approved by the FDA for use in males, specifically to treat males with hypogonadotropic hypogonadism. These agents share the common overall treatment effect of increasing intrinsic production of testosterone, but there are substantial differences in pharmacologic characteristics and mechanisms of action between them. These findings require further follow-up as they demonstrate that transference may hypothetically occur in the absence of skin-to-skin contact. More recently, a study evaluating the amount of residual testosterone identified on laundered clothing from men using an axilla-applied testosterone liquid reported the presence of 13% of a single axilla dose on 10x10 cm clothing samples.393 After laundering the clothing with various other materials, as much as 5.8% of a standard dose of one axilla was transferred to other garments.
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