In middle-aged men with low testosterone concentrations, TRT increases bone density in the lumbar spine. Mood and Quality of Life: A small number of studies have reported mixed results for improved mood, vitality, and quality of life in aging men receiving TRT. Cognition: TRT has been linked to effects on cognitive skills. Diabetes: Few clinical trials have been conducted on whether TRT can improve glucose control. Some small studies have found improvements in A1C.
In , as part of its advisory on cardiovascular risk, the FDA issued a safety announcement that TRT is approved only for use in men with low testosterone concentrations caused by hypogonadism and should not be used in those with age-related low testosterone. Despite reasonable uses for TRT both on- and off-label, questions about its risk-versus-benefit profile remain. Much of the current data show mixed results.
Risks and side effects of TRT include development or acceleration of prostate or breast cancer, development or worsening of benign prostatic hyperplasia, increased risk of polycythemia, development or worsening of acne, alopecia, gynecomastia, worsening sleep apnea, increased lower urinary tract symptoms LUTS , liver toxicity, and cardiovascular events.
Because contraindications exist, it is important to obtain a thorough history and physical examination prior to initiating TRT. Because the most commonly used testosterone preparations in women are oral, increased hepatotoxic risks are associated with the extensive first-pass metabolism of testosterone. Additional side effects in women include hirsutism, acne, voice deepening, alopecia, polycythemia, sleep apnea, and weight gain.
There is a black box warning for secondary exposure of children to topical testosterone. Testosterone may be transferred to another person following skin contact with the application site; therefore, patients should strictly adhere to instructions for use in order to prevent secondary exposure.
Children and women should avoid contact with application sites of men who are using topical products. It is most important for patients to understand that testosterone-containing products are Schedule III substances, are approved only to treat hypogonadism, and must be used as directed by the physician.
Risk Evaluation Management Strategies warnings for TRT include increased risk of heart attacks and strokes, hypertension, and pulmonary oil microembolism.
The AACE guidelines suggest that testing be performed before a patient starts using a testosterone product. A history and physical examination—including DRE—and total serum testosterone, CBC, and PSA should be performed at baseline, 3 to 6 months after therapy initiation, and then annually if stable. A bone-density scan should be obtained at baseline and then annually, in addition to annual mammogram and endometrial ultrasonography in women.
The literature supporting TRT is largely mixed and often controversial. However, there are many uses for TRT, some of them acceptable and others under debate. It is important for pharmacists to keep abreast of the available literature in order to provide the best education for patients. Miller E. Testosterone products. Accessed May 28, Trends in testosterone replacement therapy use from to among reproductive-age men in the United States.
J Urol. FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use. Transdermal testosterone replacement therapy in men. Drug Des Devel Ther. Margo K, Winn R. Testosterone treatments: why, when, and how?
Am Fam Physician. A recent study on the effects of testosterone treatment in older men showed a small increase in sexual function with testosterone treatment in some cases for less than 12 months , but no significant improvement in mood, vitality or physical function.
Do not start any testosterone treatment without careful diagnosis of androgen deficiency. Make sure you have a full health assessment, and that your testosterone levels have clearly been shown to be consistently low. Often, there are other health problems at play such as obesity and diabetes that should be treated first, which may make testosterone replacement therapy unnecessary. The effect of lower testosterone levels with increasing age and the effects of testosterone replacement therapy in men are currently being studied.
Of concern are some studies suggesting a rise in cardiovascular disease after starting testosterone therapy in older men, but this remains controversial.
Boys who have not completed puberty should only be treated by paediatric hormone specialists paediatric endocrinologists. Treatment for proven androgen deficiency is based on testosterone replacement therapy. Testosterone is best administered by skin gels creams, or by injection short- or long-acting. If your testosterone deficiency is caused by your pituitary gland and you are also wishing to father a child, your doctor will probably recommend gonadotrophin injections, several times a week for many months, to stimulate both testosterone and sperm production.
Testosterone treatment is not recommended for men trying to have a child as it acts as a powerful contraceptive by suppressing the pituitary hormones that drive sperm production. If you are androgen deficient and you and your partner are trying to have a baby, see a fertility specialist. If you are having testosterone replacement therapy you will have regular reviews with your doctor. How often you have these will depend on your age and other risk factors for prostate cancer.
Older men need to be checked for prostate cancer before testosterone replacement therapy can be started, because increased levels of testosterone could make unrecognised prostate cancer grow. However, testosterone replacement therapy is not thought to increase the risk of a new prostate cancer above that of the general population. Once testosterone levels are restored to the normal range, side effects of testosterone replacement therapy are not common.
Some of the possible side effects include:. There is a large commercial market for testosterone products or herbal products to increase testosterone production.
Do not start taking medications based on symptoms of low testosterone without consulting your doctor, who will assess your overall health and check for any serious conditions.
This page has been produced in consultation with and approved by:. Content on this website is provided for information purposes only. Information about a therapy, service, product or treatment does not in any way endorse or support such therapy, service, product or treatment and is not intended to replace advice from your doctor or other registered health professional. The information and materials contained on this website are not intended to constitute a comprehensive guide concerning all aspects of the therapy, product or treatment described on the website.
All users are urged to always seek advice from a registered health care professional for diagnosis and answers to their medical questions and to ascertain whether the particular therapy, service, product or treatment described on the website is suitable in their circumstances.
The State of Victoria and the Department of Health shall not bear any liability for reliance by any user on the materials contained on this website. Skip to main content. Reproductive system - male. Home Reproductive system - male. Androgen deficiency in men. In intra-prostatic cancer patients with normalization of PSA after permanent brachytherapy or external beam radiation therapy who developed hypogonadism, testosterone treatment determined a slight increase in PSA with no signs of recurrence or progression of the cancer C , 27 Sarosdy MF.
Testosterone replacement for hypogonadism after treatment of early prostate cancer with brachytherapy. Cancer ; Testosterone administration to men with testosterone deficiency syndrome after external beam radiotherapy for localized prostate cancer: preliminary observations. BJU Int ; Testosterone replacement therapy following radical prostatectomy. In all these studies, testosterone levels were maintained within the normal range. Testosterone replacement in prostate cancer survivors with hypogonadal symptoms.
There is no consensus on the moment for determining consolidated healing treatments with this intention in localized prostate cancer.
Short-term studies with few patients suggest that after 1 year of treatment TRT can commence if the patient is cured. The incidence of prostate cancer in men with late-onset hypogonadism on TRT is no greater than the population in general B ; 31 Prostate-specific antigen changes and prostate cancer in hypogonadal men treated with testosterone replacement therapy. TRT in older men with late-onset hypogonadism seems to have a slight effect on prostate tissue A ; 32 Effect of testosterone replacement therapy on prostate tissue in men with late-onset hypogonadism: a randomized controlled trial.
JAMA ; In patients with prostate cancer treated using radical prostatectomy, brachytherapy or radiotherapy, TRT can be used with caution, and patients should be constantly monitored C ; 27 High doses of testosterone, even if associated with 5-alpha-reductase inhibitors, cause a significant increase in PSA B.
The greatest risk of prostate cancer has been observed in men with higher estrone levels A ; 33 Sex hormones and the risk of incident prostate cancer.
Urology ; Maintaining testosterone at physiological levels increases PSA levels, but does not increase the incidence of prostate cancer. Men successfully treated for prostate cancer and diagnosed with hypogonadism are candidates for TRT after a prudent interval for observation, and there is no clinical or laboratory evidence of recurrence of the disease.
The risks and benefits of TRT should be clearly understood by the patient and treatment should be carefully monitored. The safety data in this clinical situation are still limited. Maintaining physiological serum levels of testosterone and monitoring PSA in all patients on testosterone replacement is recommended. The effects of TRT on cardiovascular risk appear to be associated with the adverse effects on polycythemia, lipid profile and sleep apnea. The maintenance of serum testosterone levels within the normal range does not lead to significant changes in hemoglobin and lipid profiles, decreasing the risk of developing polycythemia and consequently cardiovascular and vascular events B.
Trough serum testosterone predicts the development of polycythemia in hypogonadal men treated for up to 21 years with subcutaneous testosterone pellets. Assessment of possible effects for testosterone replacement therapy in men with symptomatic late-onset hypogonadism.
Andrologia ; Hyperinsulinemia and insulin resistance IR are essential components of metabolic syndrome, which in turn is associated with an increased cardiovascular risk.
TRT improves the components of metabolic syndrome in hypogonadal patients with T2DM, reducing the cardiovascular risk A. There is no evidence that TRT per se increases cardiovascular risk.
It is recommendable to maintain serum testosterone levels within the normal range so that cardiovascular risk factors such as polycythemia and insulin resistance are minimized, thereby reducing overall cardiovascular risk.
Secondary polycythemia is a major adverse event of TRT. Several authors have demonstrated its occurrence, and it is related to the maintenance of high serum levels of testosterone, regardless of the treatment time B. Therefore, the evidence available so far indicates that the maintenance of serum testosterone levels within the normal average does not lead to polycythemia B.
Effects of testosterone gel followed by parenteral testosterone undecanoate on sexual dysfunction and on features of the metabolic syndrome.
The appearance of polycythemia is directly related to supraphysiological serum testosterone levels. It is recommended to monitor hemoglobin and hematocrit in all patients on TRT and to maintain serum testosterone levels within the normal range to minimize the risk of polycythemia.
Hepatotoxicity due to TRT is a rare event limited almost exclusively to the use of oral 17a-alkylated preparations such as fluoxymesterone and methyltestosterone, which are highly hepatotoxic and can cause the development of hepatocellular adenomas, liver carcinomas, cholestasis and hemorrhagic cysts of the liver A.
The long term use of other testosterone preparations does not lead to a change in hepatic function among men with late-onset hypogonadism B. It is not recommended to monitor the liver function of patients on TRT with any other pharmaceutical form. Testosterone replacement has been associated with the onset or worsening of sleep apnea in men treated with high doses of testosterone A. The administration of testosterone in patients with sleep apnea and erectile dysfunction associated with low testosterone improves sexual symptoms and does not worsen sleep apnea C.
Sexual functions of men with obstructive sleep apnoea syndrome and hypogonadism may improve upon testosterone administration: a pilot study. Gynecomastia is a benign, infrequent and generally reversible complication, a result of the aromatization of testosterone into estradiol in peripheral tissues. Infertility and decreased testicular volume are related to supraphysiological doses of testosterone. Sodium and water retention may occur during replacement and generally present clinical significance in patients with cardiac decompensation, hypertension or renal failure.
Skin reactions such as erythema and itching are common with the use of patches. Intramuscular injections may cause local pain, lumps, rashes and boils. Acne, oily skin, increased body hair and skin "flushing" are benign and reversible complications that do not cause major concern A. The side effects of TRT, such as worsening or onset of sleep apnea, gynecomastia, infertility, fluid retention and skin changes are directly related to supraphysiological levels of serum testosterone.
It is strongly recommended to maintain serum testosterone levels within the average normal range to minimize the occurrence of these side effects.
The maintenance of serum testosterone levels within the normal range leads to improvements in the markers of metabolic syndrome, such as waist circumference, and increased levels of HDL without causing polycythemia or changes in prostatic parameters. This improvement is not as significant when testosterone levels are maintained at the lower limit of normality B. TRT does not depend on the pharmaceutical form of testosterone used or the route of administration and is effective to improve metabolic syndrome parameters; when testosterone levels are maintained within a normal range, however, the improvement is more significant B.
A dose-response study of testosterone on sexual dysfunction and features of the metabolic syndrome using testosterone gel and parenteral testosterone undecanoate. J Androl ; In T2DM patients, TRT reduces insulin resistance, improves glycemic control, and reduces visceral adiposity and total cholesterol, which are all components of metabolic syndrome A. The beneficial effects of ART on metabolic syndrome components appear to be specific to testosterone, given that chronic replacement with DHEA does not improve the secretion or action of insulin and postprandial glycemia in women and elderly men B.
There is strong evidence that testosterone replacement improves the parameters of metabolic syndrome, especially if serum levels are maintained within normal limits. We recommend maintaining serum testosterone levels within a normal range to aid in the treatment of metabolic syndrome. Oral testosterone formulations have been developed to replace injectable forms; however, some disadvantages have been noted, such as variable absorption, low bioavailability due to liver metabolism and the need for 2 to 3 daily doses D.
The current status of therapy for symptomatic late-onset hypogonadism with transdermal testosterone gel. Eur Urol. D 41 Oral testosterone undecanoate OTU , the only available oral formulation, is preferably absorbed in chylomicrons, avoiding the primary hepatic passag D 41 Although most of the studies were flawed due to the small number of participants or the variability of the dose used, the effectiveness of oral ART is questionable.
The manufacturer's recommendation is for OTU to be taken during meals, yet there is variability in absorption depending on the composition of the patient's diet A. Morales et al. Changes in serum sex hormone profiles after short-term low-dose administration of dehydroepiandrosterone DHEA to young and elderly persons.
Endocr J ; Another way to release testosterone orally is oral mucosa patches which contain 30 mg of testosterone that should be administered twice daily. In general, studies show that this form of ART is capable of maintaining physiological levels of serum testosterone, is safe and well tolerated, and is an interesting option for ART in hypogonadal men D 41 A comparison of a novel testosterone bioadhesivebuccal system, striant, with a testosterone adhesive patch in hypogonadal males.
Efficacy and safety of a new testosterone-in-adhesive matrix patch applied every 2 days for 1 year to hypogonadal men. J Steroid Biochem Mol Biol ; The underreported sublingual form of testosterone administration should be used at a dose of 2. It is rapidly absorbed and metabolized, and it does not lead to a sustained increase in serum levels of dihydrotestosterone DHT and estradiol D. Oral testosterone undecanoate does not present hepatotoxicity; however, it has proved ineffective in maintaining adequate serum testosterone levels, and has variable absorption between individuals.
Transdermal administration of ART includes patches, cutaneous gels and cutaneous solutions. The patches may be non-scrotal or scrotal, which are thinner and have more effective testosterone absorption than the non-scrotal version. It should be applied once daily on depilated scrotal skin D. Due to the large number of patches on the international market from different manufacturers, in the opinions of the authors, the tolerability of patients is quite variable due to local adverse effects.
They are considered large and uncomfortable to use, and some formulations cause local reactions and exhibit low adhesion that ends up causing low acceptability by patients B.
There are reports of patients who have discontinued treatment due to allergic reactions at the application site, even when using a local corticosteroid ointment B. On the other hand, the authors are unanimous regarding the efficacy and safety of this type of ART. The transdermal patches available provide physiological and constant levels of serum testosterone, and mimic the circadian rhythm. Open-label pilot study of testosterone patch therapy in men with opioid-induced androgen deficiency.
J Pain ; Comparison of the steady-state pharmacokinetics, metabolism, and variability of a transdermal testosterone patch versus a transdermal testosterone gel in hypogonadal men.
Pharmacokinetic study of a new testosterone-in-adhesive matrix patch applied every 2 days to hypogonadal men. With respect to security, Raynaud et al. Many patients prefer transdermal gels or solutions as they are easy to apply, substantially free of local reactions and do not require injections D.
Lakshman KM, Basaria S. Safety and efficacy of testosterone gel in the treatment of male hypogonadism. Clin Interv Aging ; Testosterone gel should be applied in the morning on dry skin on the shoulders, arms or abdomen. Patients should wash hands well after application and let the application site dry before putting on clothes. It is recommended to wait 4 hours after application to bathe or swim. The application site should be washed with soap and water if there is direct contact with another person D.
Testosterone gels at the recommended doses are able to restore the physiological serum testosterone levels but they do not mimic the circadian rhythm B 46
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