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Androgen replacement therapy

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This article is about Androgen replacement therapy for cisgender people. For transgender applications, see Masculinizing hormone therapy.

Androgen replacement therapy
Other namesTestosterone replacement therapy

Androgen replacement therapy (ART), often referred to as testosterone replacement therapy (TRT), is a form of hormone therapy in which androgens, often testosterone, are supplemented or replaced. It typically involves the administration of testosterone through injections, skin creams, patches, gels, pills, or subcutaneous pellets. ART is often prescribed to counter the effects of male hypogonadism.

ART is also prescribed to lessen the effects or delay the onset of normal male aging. However, this is controversial and is the subject of ongoing clinical trials.[1][2][3][4][5][6][7]

As men enter middle age they may notice changes caused by a relative decline in testosterone: fewer erections, fatigue, thinning skin, declining muscle mass and strength, and/or more body fat. Dissatisfaction with these changes causes some middle age men to seek ART. Androgen deficiencies in women have also, as of 2001, been recognized as a medical disorder that can be treated with ART.[8] As with men, symptoms associated with androgen deficiency are most prevalent with age, and androgen replacement therapy has been shown to help with symptoms of menopause.[9]

Medical uses

[edit]
See also: Testosterone (medication)

Males

[edit]

Androgen replacement is the classic treatment of hypogonadism.[10] It is also used in men who have lost the ability to produce androgens due to disease or its treatment.[11][12]

Androgen replacement therapy formulations and dosages used in men
Route Medication Major brand names Form Dosage
Oral Testosteronea – Tablet 400–800 mg/day (in divided doses)
Testosterone undecanoate Andriol, Jatenzo Capsule 40–80 mg/2–4× day (with meals)
Methyltestosteroneb Android, Metandren, Testred Tablet 10–50 mg/day
Fluoxymesteroneb Halotestin, Ora-Testryl, Ultandren Tablet 5–20 mg/day
Metandienoneb Dianabol Tablet 5–15 mg/day
Mesteroloneb Proviron Tablet 25–150 mg/day
Sublingual Testosteroneb Testoral Tablet 5–10 mg 1–4×/day
Methyltestosteroneb Metandren, Oreton Methyl Tablet 10–30 mg/day
Buccal Testosterone Striant Tablet 30 mg 2×/day
Methyltestosteroneb Metandren, Oreton Methyl Tablet 5–25 mg/day
Transdermal Testosterone AndroGel, Testim, TestoGel Gel 25–125 mg/day
Androderm, AndroPatch, TestoPatch Non-scrotal patch 2.5–15 mg/day
Testoderm Scrotal patch 4–6 mg/day
Axiron Axillary solution 30–120 mg/day
Androstanolone (DHT) Andractim Gel 100–250 mg/day
Rectal Testosterone Rektandron, Testosteronb Suppository 40 mg 2–3×/day
Injection (IMTooltip intramuscular injection or SCTooltip subcutaneous injection) Testosterone Andronaq, Sterotate, Virosterone Aqueous suspension 10–50 mg 2–3×/week
Testosterone propionateb Testoviron Oil solution 10–50 mg 2–3×/week
Testosterone enanthate Delatestryl Oil solution 50–250 mg 1x/1–4 weeks
Xyosted Auto-injector 50–100 mg 1×/week
Testosterone cypionate Depo-Testosterone Oil solution 50–250 mg 1x/1–4 weeks
Testosterone isobutyrate Agovirin Depot Aqueous suspension 50–100 mg 1x/1–2 weeks
Testosterone phenylacetateb Perandren, Androject Oil solution 50–200 mg 1×/3–5 weeks
Mixed testosterone esters Sustanon 100, Sustanon 250 Oil solution 50–250 mg 1×/2–4 weeks
Testosterone undecanoate Aveed, Nebido Oil solution 750–1,000 mg 1×/10–14 weeks
Testosterone buciclatea – Aqueous suspension 600–1,000 mg 1×/12–20 weeks
Implant Testosterone Testopel Pellet 150–1,200 mg/3–6 months
Notes: Men produce about 3 to 11 mg of testosterone per day (mean 7 mg/day in young men). Footnotes: a = Never marketed. b = No longer used and/or no longer marketed. Sources: See template.

Diabetes

[edit]

The risks of diabetes and of testosterone deficiency in men over 45 (i.e., hypogonadism, specifically hypoandrogenism) are strongly correlated. Testosterone replacement therapies have been shown to improve blood glucose management.[13][14] Still, "it is prudent not to start testosterone therapy in men with diabetes solely for the purpose of improving metabolic control if they show no signs and symptoms of hypogonadism."[15]

Females

[edit]

Androgen replacement is used in postmenopausal women: the indications are to increase sexual desire; and to prevent or treat osteoporosis.[16] Other symptoms of androgen deficiency are similar in both sexes, such as muscle loss and physical fatigue.[8] The androgens used for androgen replacement in women include testosterone (and esters), prasterone (dehydroepiandrosterone; DHEA) (and the ester prasterone enanthate), methyltestosterone, nandrolone decanoate, and tibolone, among others.[16]

Androgen replacement therapy formulations and dosages used in women
Route Medication Major brand names Form Dosage
Oral Testosterone undecanoate Andriol, Jatenzo Capsule 40–80 mg 1x/1–2 days
Methyltestosterone Metandren, Estratest Tablet 0.5–10 mg/day
Fluoxymesterone Halotestin Tablet 1–2.5 mg 1x/1–2 days
Normethandronea Ginecoside Tablet 5 mg/day
Tibolone Livial Tablet 1.25–2.5 mg/day
Prasterone (DHEA)b – Tablet 10–100 mg/day
Sublingual Methyltestosterone Metandren Tablet 0.25 mg/day
Transdermal Testosterone Intrinsa Patch 150–300 μg/day
AndroGel Gel, cream 1–10 mg/day
Vaginal Prasterone (DHEA) Intrarosa Insert 6.5 mg/day
Injection Testosterone propionatea Testoviron Oil solution 25 mg 1x/1–2 weeks
Testosterone enanthate Delatestryl, Primodian Depot Oil solution 25–100 mg 1x/4–6 weeks
Testosterone cypionate Depo-Testosterone, Depo-Testadiol Oil solution 25–100 mg 1x/4–6 weeks
Testosterone isobutyratea Femandren M, Folivirin Aqueous suspension 25–50 mg 1x/4–6 weeks
Mixed testosterone esters Climacterona Oil solution 150 mg 1x/4–8 weeks
Omnadren, Sustanon Oil solution 50–100 mg 1x/4–6 weeks
Nandrolone decanoate Deca-Durabolin Oil solution 25–50 mg 1x/6–12 weeks
Prasterone enanthatea Gynodian Depot Oil solution 200 mg 1x/4–6 weeks
Implant Testosterone Testopel Pellet 50–100 mg 1x/3–6 months
Notes: Premenopausal women produce about 230 ± 70 μg testosterone per day (6.4 ± 2.0 mg testosterone per 4 weeks), with a range of 130 to 330 μg per day (3.6–9.2 mg per 4 weeks). Footnotes: a = Mostly discontinued or unavailable. b = Over-the-counter. Sources: See template.

Adverse effects

[edit]
See also: Testosterone § Adverse effects

The Food and Drug Administration (FDA) stated in 2015 that neither the benefits nor the safety of testosterone have been established for low testosterone levels due to aging.[17] The FDA has required that testosterone labels include warning information about the possibility of an increased risk of heart attacks and stroke.[17]

Heart disease

[edit]

On January 31, 2014, reports of strokes, heart attacks, and deaths in men taking testosterone-replacement led the FDA to announce that it would be investigating this issue.[18] The FDA's action followed three peer-reviewed studies of increased cardiovascular events and deaths.[19] Due to an increased rate of adverse cardiovascular events compared to a placebo group, a randomized trial stopped early.[20] Also, in November 2013, a study reported an increase in deaths and heart attacks in older men.[21] Concerns have been raised that testosterone was being widely marketed without the benefit of data on efficacy and safety from large randomized controlled trials.[22] As a result of the "potential for adverse cardiovascular outcomes", the FDA announced, in September 2014, a review of the appropriateness and safety of testosterone replacement therapy.[23][24][25] However, when given to men with hypogonadism in the short- and medium-term, testosterone replacement therapy does not increase the risk of cardiovascular events (including strokes and heart attacks and other heart diseases).[2] The long-term safety of the therapy is not known yet.[26][27]

Other

[edit]

Other significant adverse effects of testosterone supplementation include acceleration of pre-existing prostate cancer growth in individuals who have undergone androgen deprivation; increased hematocrit, which can require venipuncture in order to treat; and, exacerbation of sleep apnea.[28] A 2014 review said there was some evidence men with certain comorbidities may be at risk of adverse effects including sleep apnoea, metabolic syndrome and cardiovascular disease.[29] Exogenous testosterone may also cause suppression of spermatogenesis, leading to, in some cases, infertility.[30] It is recommended that physicians screen for prostate cancer with a digital rectal exam and prostate-specific antigen (PSA) level before starting therapy, and monitor PSA and hematocrit levels closely during therapy.[31]

Some studies argue that ART increases the risk of prostate cancer, although the results are not conclusive.[32]

Methods of administration

[edit]

There are several artificial androgens, many of which are manipulations of the testosterone molecule referred to as anabolic-androgenic steroids. Androgen replacement is administered by patch, tablet, capsule, cream or gel; or depot injections given into fat or muscle.[18]

Society and culture

[edit]

MMA

[edit]

Some UFC fighters used TRT until 2014 when the Nevada State Athletic Commission banned its use.[33]

Regulation

[edit]

As of September 2014, testosterone replacement therapy has been under review for appropriateness and safety by the Food and Drug Administration due to the "potential for adverse cardiovascular outcomes".[23][24][25]

Frequency of use

[edit]

In the United States usage increased from 0.5% in 2002 to 3.2% in 2013 and have since decreased to 1.7% in 2016.[34]

A UK study in 2013 showed that prescriptions for testosterone replacement, particularly transdermal products, almost doubled between 2000 and 2010.[35]

Research

[edit]

Testosterone is being investigated as therapy for the following conditions:

See also

[edit]

References

[edit]
  1. ^ "Testosterone therapy: Key to male vitality?". Mayo Foundation for Medical Education and Research (MFMER). 2012.
  2. ^ a b Sood A, Hosseinpour A, Sood A, Avula S, Durrani J, Bhatia V, Gupta R (October 2023). "Cardiovascular Outcomes of Hypogonadal Men Receiving Testosterone Replacement Therapy: A Meta-analysis of Randomized Controlled Trials". Endocrine Practice. 30 (1): 2–10. doi:10.1016/j.eprac.2023.09.012. PMID 37797887. S2CID 263692728.
  3. ^ Valderrábano RJ, Pencina K, Storer TW, Reid KF, Kibel AS, Burnett AL, et al. (January 2023). "Testosterone replacement in prostate cancer survivors with testosterone deficiency: Study protocol of a randomized controlled trial". Andrology. 11 (1): 93–102. doi:10.1111/andr.13299. PMC 9771994. PMID 36181480.
  4. ^ Pencina KM, Travison TG, Artz AS, Lincoff AM, Nissen SE, Flevaris P, et al. (October 2023). "Efficacy of Testosterone Replacement Therapy in Correcting Anemia in Men With Hypogonadism: A Randomized Clinical Trial". JAMA Network Open. 6 (10): e2340030. doi:10.1001/jamanetworkopen.2023.40030. PMC 10611996. PMID 37889486.
  5. ^ Christensen LL, Poulsen HE, Andersen MS, Glintborg D (January 2024). "Whole-body oxidative stress reduction during testosterone therapy in aging men: A randomized placebo-controlled trial". Andrology. 12 (1): 115–122. doi:10.1111/andr.13458. PMID 37177884.
  6. ^ Diaz P, Reddy R, Blachman-Braun R, Zucker I, Dullea A, Gonzalez DC, et al. (April 2023). "Comparison of Intratesticular Testosterone between Men Receiving Nasal, Intramuscular, and Subcutaneous Pellet Testosterone Therapy: Evaluation of Data from Two Single-Center Randomized Clinical Trials". The World Journal of Men's Health. 41 (2): 390–395. doi:10.5534/wjmh.210261. PMC 10042650. PMID 35791295.
  7. ^ Corona G, Torres LO, Maggi M (March 2020). "Testosterone Therapy: What We Have Learned From Trials". The Journal of Sexual Medicine. 17 (3): 447–460. doi:10.1016/j.jsxm.2019.11.270. hdl:2158/1192573. PMID 31928918. S2CID 210191244.
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  12. ^ Ukwenya VO (2019). "Testosterone propionate ameliorates oxidatve stress and inflammation in nicotine-induced testicular toxicity". Journal of Experimental and Clinical Anatomy. 18 (1): 74–78. doi:10.4103/jeca.jeca_10_19 (inactive November 2, 2024). S2CID 208531742.{{cite journal}}: CS1 maint: DOI inactive as of November 2024 (link)
  13. ^ Morales A, Bella AJ, Chun S, Lee J, Assimakopoulos P, Bebb R, et al. (August 2010). "A practical guide to diagnosis, management and treatment of testosterone deficiency for Canadian physicians". Canadian Urological Association Journal. 4 (4): 269–275. doi:10.5489/cuaj.880. PMC 2910774. PMID 20694106.
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  18. ^ a b Staff (January 31, 2014). "FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products" (PDF). U.S. Food and Drug Administration. Retrieved September 17, 2014.
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  20. ^ Basaria S, Coviello AD, Travison TG, Storer TW, Farwell WR, Jette AM, et al. (July 2010). "Adverse events associated with testosterone administration". The New England Journal of Medicine. 363 (2): 109–122. doi:10.1056/NEJMoa1000485. PMC 3440621. PMID 20592293.
  21. ^ Vigen R, O'Donnell CI, Barón AE, Grunwald GK, Maddox TM, Bradley SM, et al. (November 2013). "Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels". JAMA. 310 (17): 1829–1836. doi:10.1001/jama.2013.280386. PMID 24193080.
  22. ^ McCullough M (April 4, 2014). "As testosterone use grows, questions on risks await answers". Philly.com. Archived from the original on April 7, 2014. Retrieved March 19, 2015.
  23. ^ a b Tavernise S (September 17, 2014). "F.D.A. Panel Backs Limits on Testosterone Drugs". The New York Times. Retrieved September 18, 2014.
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  25. ^ a b Staff (September 17, 2014). "Joint Meeting for Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) and the Drug Safety And Risk Management Advisory Committee (DSARM AC) - FDA background documents for the discussion of two major issues in testosterone replacement therapy (TRT): 1. The appropriate indicated population for TRT, and 2. The potential for adverse cardiovascular outcomes associated with use of TRT" (PDF). Food and Drug Administration. Retrieved September 14, 2014.
  26. ^ "Research provides reassurance about the safety of testosterone treatment". NIHR Evidence (Plain English summary). National Institute for Health and Care Research. February 6, 2023. doi:10.3310/nihrevidence_56696. S2CID 257851823.
  27. ^ Hudson J, Cruickshank M, Quinton R, Aucott L, Aceves-Martins M, Gillies K, et al. (June 2022). "Adverse cardiovascular events and mortality in men during testosterone treatment: an individual patient and aggregate data meta-analysis". The Lancet. Healthy Longevity. 3 (6): e381–e393. doi:10.1016/S2666-7568(22)00096-4. PMC 9184259. PMID 35711614.
  28. ^ Pastuszak AW, Pearlman AM, Lai WS, Godoy G, Sathyamoorthy K, Liu JS, et al. (August 2013). "Testosterone replacement therapy in patients with prostate cancer after radical prostatectomy". The Journal of Urology. 190 (2): 639–644. doi:10.1016/j.juro.2013.02.002. PMC 4544840. PMID 23395803.
  29. ^ Grech A, Breck J, Heidelbaugh J (October 2014). "Adverse effects of testosterone replacement therapy: an update on the evidence and controversy". Therapeutic Advances in Drug Safety. 5 (5): 190–200. doi:10.1177/2042098614548680. PMC 4212439. PMID 25360240.
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  32. ^ Barqawi A, Crawford ED (2006). "Testosterone replacement therapy and the risk of prostate cancer. Is there a link?". International Journal of Impotence Research. 18 (4): 323–8. doi:10.1038/sj.ijir.3901418. PMID 16281043. S2CID 46230482.
  33. ^ "Nevada commission bans testosterone replacement". AP News. February 27, 2014.
  34. ^ Baillargeon J, Kuo YF, Westra JR, Urban RJ, Goodwin JS (July 2018). "Testosterone Prescribing in the United States, 2002-2016". JAMA. 320 (2): 200–202. doi:10.1001/jama.2018.7999. PMC 6396809. PMID 29998328.
  35. ^ Gan EH, Pattman S, Pearce HS, Quinton R (October 2013). "A UK epidemic of testosterone prescribing, 2001-2010". Clinical Endocrinology. 79 (4): 564–570. doi:10.1111/cen.12178. PMID 23480258. S2CID 4952458.
  36. ^ Walther A, Mahler F, Debelak R, Ehlert U (May 2017). "Psychobiological Protective Factors Modifying the Association Between Age and Sexual Health in Men: Findings From the Men's Health 40+ Study". American Journal of Men's Health. 11 (3): 737–747. doi:10.1177/1557988316689238. PMC 5675228. PMID 28413941.
  37. ^ Finkelstein JS, Lee H, Leder BZ, Burnett-Bowie SA, Goldstein DW, Hahn CW, et al. (March 2016). "Gonadal steroid-dependent effects on bone turnover and bone mineral density in men". The Journal of Clinical Investigation. 126 (3): 1114–1125. doi:10.1172/JCI84137. PMC 4767351. PMID 26901812.
  38. ^ Farley JF, Blalock SJ (July 2009). "Trends and determinants of prescription medication use for treatment of osteoporosis". American Journal of Health-System Pharmacy. 66 (13): 1191–1201. doi:10.2146/ajhp080248. PMID 19535658.
  39. ^ Traish AM, Saad F, Guay A (2009). "The dark side of testosterone deficiency: II. Type 2 diabetes and insulin resistance". Journal of Andrology. 30 (1): 23–32. doi:10.2164/jandrol.108.005751. PMID 18772488. S2CID 29463129.
  40. ^ Boyanov MA, Boneva Z, Christov VG (March 2003). "Testosterone supplementation in men with type 2 diabetes, visceral obesity and partial androgen deficiency". The Aging Male. 6 (1): 1–7. doi:10.1080/tam.6.1.1.7. PMID 12809074. S2CID 7328751.
  41. ^ Caminiti G, Volterrani M, Iellamo F, Marazzi G, Massaro R, Miceli M, et al. (September 2009). "Effect of long-acting testosterone treatment on functional exercise capacity, skeletal muscle performance, insulin resistance, and baroreflex sensitivity in elderly patients with chronic heart failure a double-blind, placebo-controlled, randomized study". Journal of the American College of Cardiology. 54 (10): 919–927. doi:10.1016/j.jacc.2009.04.078. PMID 19712802.
  42. ^ Cherrier M (2009). "Testosterone effects on cognition in health and disease". Frontiers of Hormone Research. 37: 150–162. doi:10.1159/000176051. ISBN 978-3-8055-8622-1. PMID 19011295.
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