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Studies reporting optimal testosterone levels yielded a mean 2.2 kg increase in lean body mass compared to a non-significant 0.8 kg increase when suboptimal levels of testosterone were achieved. As with other symptoms, the duration of testosterone therapy likely has a significant impact on overall bone density benefits. An increase in BMD is an important potential benefit of testosterone therapy for men who might be at risk for LTBF. Improvements in sex drive were also assessed in another meta-analysis performed by Bolona et al.298 Using a variety of measures, the authors demonstrated improvement with a pooled effect of 1.31 (31% increase in sex drive) among men treated with testosterone, with greater improvements noted among men with lower baseline testosterone levels.
Most authors with an interest in 17β-estradiol have suggested that the effectiveness of testosterone, when it has shown effectiveness, is due to aromatization to 17β-estradiol. Treatment of men with suspected or diagnosed Alzheimer disease or cognitive impairment was reported in five studies, two of which had a Jadad score above 3. Another injection study found no effect of supplementation on memory in hypogonadal men. The response of depression and dysthymia to testosterone was mixed and inconsistent. The study that used hostility assessments by undergraduate judges found no change in personality as assessed by the Gough and Heilbrun Adjective Check List. Twenty-nine of these studies focused on men without psychiatric disorders, and 16 on men with psychiatric disorders.
Complex statistical analysis using a methodology known a stabilized inverse propensity treatment weighting was utilized to adjust for 50 potentially confounding variables. SQ testosterone pellets were initially developed and FDA approved in 1972 and were reformulated in the USA in 2008. Long-acting IM testosterone injection may also result in higher rates of polycythemia when compared to topical therapies, which is consistent with other short-acting IM testosterone therapies.
He has consulted for manufacturers of testosterone products, but never about testosterone. A licensed medical practitioner should be consulted for diagnosis and treatment of any and all medical conditions. Our Find a Provider tool makes it easy to search Cleveland Clinic’s trusted network. Cleveland Clinic’s experts can help balance your hormones. See a provider and discuss your options for treatment. If you have bothersome signs of low testosterone, avoid over-the-counter supplements.
To accurately interpret the published testosterone literature, it is important to critically evaluate various aspects of study design, including the population evaluated, study inclusion/exclusion criteria, duration of follow-up, primary endpoints, adverse event reporting, statistical reporting, and clinical relevance of findings. This is further complicated by laboratory methodology issues, such as time of day for the blood draws analyzed, number of levels checked, and assays used. An exception can be made if patients do not have symptoms but have documented BMD loss. Please refer to Table 7 below for a summary of follow-up testing for men being treated for testosterone deficiency. Patients on short-acting IM or short-acting SQ pellets (testosterone cypionate or enanthate) should have their testosterone measured after several cycles such that testosterone level equilibration has been achieved. Patients on topical gels, patches, and intranasal formulations should have their testosterone checked between two to four weeks after commencement of therapy. + FDA approved for use in males with hypogonadotropic hypogonadism and pediatric patients with cryptorchidism.
Hypogonadism has more recently been used interchangeably with the idea of low testosterone production alone. Commercially manufactured testosterone products should be prescribed rather than compounded testosterone, when possible. Clinicians should not prescribe alkylated oral testosterone. In the absence of sufficient evidence, additional information is provided as Clinical Principles and Expert Opinions. In second pass, an additional 419 studies were excluded. The original guideline search strategy was updated and used to systematically search PubMed for new evidence published between the previous search end date and February 2022. An updated evidence search was subsequently performed in 2022. Another study showed no effect of IM testosterone enanthate on ejection fraction, although there was an improvement in a Doppler-based myocardial performance index. Intramuscular (IM) testosterone treatment for 12 weeks improved exercise capacity and reduced heart failure symptom scores without identifiable effects on left ventricular size or ejection fraction (EF). There was a decreased incidence of silent MI with testosterone treatment in 1 study. The remaining eight studies evaluated treatments of 2 to 24 weeks in duration.1, 3, 10, 11, 13–17 The 3 studies that looked at time to ST-segment depression found a benefit of testosterone supplementation.1, 14, 16|In studies of HIV-positive men with weight loss, 3 of 6 studies (all of which had Jadad scores of 4 or 5) showed an increase in weight with testosterone treatment,99, 101, 106 and all 4 studies that measured muscle mass showed an increase.41, 99–101 Five of the 14 studies not showing favorable effects on lipids used IM injection of testosterone esters, cypionate, or undecanoate. Seven of the 11 studies showing favorable effects used IM injection of testosterone enanthate, esters, or undecanoate. Most of the studies that did not report favorable effects of testosterone on lipids reported no effects at all.|Early morning samples from each subject's most recent and previous 3 visits as well as those from 10, 15, 20, 25, and 30 years prior were analyzed (3,565 samples total with a mean of 4 samples per patient). To merely refer to injectable or gel testosterone formulations without differentiation does not impart complete and accurate information to the reader. Finally, testosterone pellets are also available in branded form, with no generic agents currently available. For example, there are several testosterone gels available in 1%, 1.62%, and 2% formulations, each marketed under a different brand or generic name. While all products contain the same medication (testosterone), each product and modality has distinct pharmacokinetic and application attributes based on the excipient agents and the permeator components.|Five studies examined the effects of testosterone supplementation on physical frailty, functional limitations, or a categorization as "sedentary,"53, 80–83 and single studies evaluated subjects with COPD, advanced cancer, and Parkinson’s disease. On the sexual subscale of the AMS scale, this study reported a benefit, Ho et al found no benefit, and Legros et al found a benefit of testosterone on the AMS sexual subscale only in the middle (160 mg) of 3 dose levels at 3 of 4 time points. Five studies found no difference between testosterone and placebo on total scores,26, 54, 57, 72, 76 and 4 studies found a benefit of testosterone.52, 57, 58, 66 One paper reported only sexual subscales but not total AMS scores.|Other meta-analyses that have included observational studies with less stringent inclusion criteria have demonstrated variable improvements in fasting glucose, insulin resistance, and HbA1c levels.138, 325, 326 One trial with three years of follow-up showed near linear, time-dependent improvements in BMD.202 These findings are similar to other prospective, controlled data, which report an estimated 5% per year increase in BMD in men on testosterone therapy.309 Declining bone density may necessitate additional medical intervention, such as weight bearing exercise, calcium, vitamin D, or bisphosphonate medications. Given the link between LTBF and morbidity and mortality in older men, evaluating bone density is an important step in the assessment of patients with testosterone deficiency. At the present time, there are insufficient data available to predict which men with ED are most likely to respond to testosterone therapy.|The AUA and the Testosterone Panel were committed to creating a Guideline that ensures that men in need of testosterone therapy are treated effectively and safely. Guidance is also given on the management of patients with cardiovascular disease, men who are interested in preserving their fertility and men who are at risk for or have prostate cancer. The Evaluation and Management of Testosterone Deficiency AUA Guideline provides guidance to the practicing clinician on how to diagnose, treat and monitor the adult male with testosterone deficiency. Everlywell offers at-home hormone tests, including testosterone testing, so you can track your levels conveniently and confidentially. Testosterone plays a key role in sexual development, reproductive function, body composition, energy levels, and mood. "Everyone agrees that if you have a phenomenally low level, you’d benefit from treatment. Afternoon tests may give a false impression of low levels."|A review by Millar et al.4 searched MEDLINE and Embase databases from January 1966 to July 2014 for studies that compared clinical indication of low testosterone along with a measurement of serum testosterone in men. When body of evidence strength Grade C is used, there is uncertainty regarding the balance between benefits and risks/burdens, alternative strategies may be equally reasonable, and better evidence is likely to change confidence. When body of evidence strength Grade B is used, benefits and risks/burdens appear balanced, the best action also depends on individual patient circumstances, and better evidence could change confidence.|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. These findings are supported by a multi-institutional study that reported that with variable dosing and clinical protocols, most men required re-implantation after four months, with all men returning to sub therapeutic levels by six months.447 Men with total testosterone level 315 ng/dL declined from 100% at 4 weeks to 86%, 75%, and 14% by 12, 20, and 24 weeks, respectively. Further individualization may be considered based on trough testosterone levels at the end of a 10-week injection cycle. One study reported comparative pharmacokinetics between IM testosterone enanthate (250 mg every 3 weeks) and IM testosterone undenaconate (1,000 mg every 9 weeks, a dosage that is only available outside the United States).440 Results demonstrated that IM testosterone enanthate achieved trough levels of 239 ng/dL compared to 470 ng/dL with IM testosterone undecanoate at the end of the 10-week cycle.}

Bradley Kingsmill, 20 years

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