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. 2024 Jan 15;1(1):CD013071.
doi: 10.1002/14651858.CD013071.pub2.

Testosterone replacement in men with sexual dysfunction

Hunju Lee #  1 , Eu Chang Hwang #  2   3 , Cheol Kyu Oh  4 , Solam Lee  5 , Ho Song Yu  6 , Jung Soo Lim  7 , Hong Wook Kim  8 , Thomas Walsh  9 , Myung Ha Kim  10 , Jae Hung Jung  3   11   12 , Philipp Dahm  13   14
Affiliations

Testosterone replacement in men with sexual dysfunction

Hunju Lee et al. Cochrane Database Syst Rev. .

Abstract

Background: Clinical practice guidelines recommend testosterone replacement therapy (TRT) for men with sexual dysfunction and testosterone deficiency. However, TRT is commonly promoted in men without testosterone deficiency and existing trials often do not clearly report participants' testosterone levels or testosterone-related symptoms. This review assesses the potential benefits and harms of TRT in men presenting with complaints of sexual dysfunction.

Objectives: To assess the effects of testosterone replacement therapy compared to placebo or other medical treatments in men with sexual dysfunction.

Search methods: We performed a comprehensive search of CENTRAL (the Cochrane Library), MEDLINE, EMBASE, and the trials registries ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform, with no restrictions on language of publication or publication status, up to 29 August 2023.

Selection criteria: We included randomized controlled trials (RCTs) in men (40 years or over) with sexual dysfunction. We excluded men with primary or secondary hypogonadism. We compared testosterone or testosterone with phosphodiesterase-5 inhibitors (PDEI5I) to placebo or PDE5I alone.

Data collection and analysis: Two review authors independently screened the literature, assessed the risk of bias, extracted data, and rated the certainty of evidence (CoE) according to GRADE using a minimally contextualized approach. We performed statistical analyses using a random-effects model and interpreted them according to standard Cochrane methodology. Predefined primary outcomes were self-reported erectile dysfunction assessed by a validated instrument, sexual quality of life assessed by a validated instrument, and cardiovascular mortality. Secondary outcomes were treatment withdrawal due to adverse events, prostate-related events, and lower urinary tract symptoms (LUTS). We distinguished between short-term (up to 12 months) and long-term (> 12 months) outcomes.

Main results: We identified 43 studies with 11,419 randomized participants across three comparisons: testosterone versus placebo, testosterone versus PDE5I, and testosterone with PDE5I versus PDE5I alone. This abstract focuses on the most relevant comparison of testosterone versus placebo. Testosterone versus placebo (up to 12 months) Based on a predefined sensitivity analysis of studies at low risk of bias, and an analysis combing data from the similar International Index of Erectile Function (IIEF-EF) and IIEF-5 instruments, TRT likely results in little to no difference in erectile function assessed with the IIEF-EF (mean difference (MD) 2.37, 95% confidence interval (CI) 1.67 to 3.08; I² = 0%; 6 RCTs, 2016 participants; moderate CoE) on a scale from 6 to 30 with larger values reflecting better erectile function. We assumed a minimal clinically important difference (MCID) of greater than or equal to 4. TRT likely results in little to no change in sexual quality of life assessed with the Aging Males' Symptoms scale (MD -2.31, 95% CI -3.63 to -1.00; I² = 0%; 5 RCTs, 1030 participants; moderate CoE) on a scale from 17 to 85 with larger values reflecting worse sexual quality of life. We assumed a MCID of greater than or equal to 10. TRT also likely results in little to no difference in cardiovascular mortality (risk ratio (RR) 0.83, 95% CI 0.21 to 3.26; I² = 0%; 10 RCTs, 3525 participants; moderate CoE). Based on two cardiovascular deaths in the placebo group and an assumed MCID of 3%, this would correspond to no additional deaths per 1000 men (95% CI 1 fewer to 4 more). TRT also likely results in little to no difference in treatment withdrawal due to adverse events, prostate-related events, or LUTS. Testosterone versus placebo (later than 12 months) We are very uncertain about the longer-term effects of TRT on erectile dysfunction assessed with the IIEF-EF (MD 4.20, 95% CI -2.03 to 10.43; 1 study, 42 participants; very low CoE). We did not find studies reporting on sexual quality of life or cardiovascular mortality. We are very uncertain about the effect of testosterone on treatment withdrawal due to adverse events. We found no studies reporting on prostate-related events or LUTS.

Authors' conclusions: In the short term, TRT probably has little to no effect on erectile function, sexual quality of life, or cardiovascular mortality compared to a placebo. It likely results in little to no difference in treatment withdrawals due to adverse events, prostate-related events, or LUTS. In the long term, we are very uncertain about the effects of TRT on erectile function when compared to placebo; we did not find data on its effects on sexual quality of life or cardiovascular mortality. The certainty of evidence ranged from moderate (signaling that we are confident that the reported effect size is likely to be close to the true effect) to very low (indicating that the true effect is likely to be substantially different). The findings of this review should help to inform future guidelines and clinical decision-making at the point of care.

Trial registration: ClinicalTrials.gov NCT01816295 NCT00244023 NCT00696748 NCT01419236 NCT00799617 NCT00512707 NCT00240981.

PubMed Disclaimer

Conflict of interest statement

Hunju Lee (HL): editor for the Korean Satellite of Cochrane Urology, but was excluded from the editorial processing of this review.

Eu Chang Hwang (ECH): editor for Cochrane Urology, but was excluded from the editorial processing of this review.

Cheol Kyu Oh (CKO): none known.

Solam Lee (SL): none known.

Ho Song Yu (HSY): none known.

Jung Soo Lim (JSL): none known.

Hong Wook Kim (HWK): none known.

Thomas Walsh (TW): Biote (Independent Contractor ‐ Consultant).

Myung Ha Kim (MHK): none known.

Jae Hung Jung (JHJ): editor for Cochrane Urology, but was excluded from the editorial processing of this review.

Philipp Dahm (PD): editor for Cochrane Urology, but was excluded from the editorial processing of this review.

Figures

1
1
2
2
Risk of bias summary: review authors' judgments about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1: Testosterone versus placebo (short‐term), Outcome 1: Erectile function (AMS sexual)
1.2
1.2. Analysis
Comparison 1: Testosterone versus placebo (short‐term), Outcome 2: Erectile function (IIEF)
1.3
1.3. Analysis
Comparison 1: Testosterone versus placebo (short‐term), Outcome 3: Erectile function (conversion to IIEF‐EF)
1.4
1.4. Analysis
Comparison 1: Testosterone versus placebo (short‐term), Outcome 4: Sexual quality of life (AMS total)
1.5
1.5. Analysis
Comparison 1: Testosterone versus placebo (short‐term), Outcome 5: Sexual quality of life (IIEF‐overall satisfaction)
1.6
1.6. Analysis
Comparison 1: Testosterone versus placebo (short‐term), Outcome 6: Cardiovascular mortality
1.7
1.7. Analysis
Comparison 1: Testosterone versus placebo (short‐term), Outcome 7: Treatment withdrawal due to adverse events
1.8
1.8. Analysis
Comparison 1: Testosterone versus placebo (short‐term), Outcome 8: Prostate‐related events
1.9
1.9. Analysis
Comparison 1: Testosterone versus placebo (short‐term), Outcome 9: Lower urinary tract symptoms
1.10
1.10. Analysis
Comparison 1: Testosterone versus placebo (short‐term), Outcome 10: Erectile function (subgroup: age and testosterone level, conversion to IIEF‐EF)
1.11
1.11. Analysis
Comparison 1: Testosterone versus placebo (short‐term), Outcome 11: Cardiovascular mortality (subgroup: age and testosterone level)
1.12
1.12. Analysis
Comparison 1: Testosterone versus placebo (short‐term), Outcome 12: Erectile function (subgroup: metabolic syndrome (MS), conversion to IIEF‐EF)
1.13
1.13. Analysis
Comparison 1: Testosterone versus placebo (short‐term), Outcome 13: Sexual quality of life (subgroup: metabolic syndrome (MS), AMS total)
1.14
1.14. Analysis
Comparison 1: Testosterone versus placebo (short‐term), Outcome 14: Sexual quality of life (subgroup: metabolic syndrome (MS), IIEF ‐ overall satisfaction)
1.15
1.15. Analysis
Comparison 1: Testosterone versus placebo (short‐term), Outcome 15: Cardiovascular mortality (subgroup: metabolic syndrome (MS))
1.16
1.16. Analysis
Comparison 1: Testosterone versus placebo (short‐term), Outcome 16: Erectile function (conversion to IIEF‐EF; sensitivity analysis)
1.17
1.17. Analysis
Comparison 1: Testosterone versus placebo (short‐term), Outcome 17: Sexual quality of life (AMS total; sensitivity analysis)
1.18
1.18. Analysis
Comparison 1: Testosterone versus placebo (short‐term), Outcome 18: Sexual quality of life (IIEF‐overall satisfaction; sensitivity analysis)
1.19
1.19. Analysis
Comparison 1: Testosterone versus placebo (short‐term), Outcome 19: Treatment withdrawal due to adverse events (sensitivity analysis)
1.20
1.20. Analysis
Comparison 1: Testosterone versus placebo (short‐term), Outcome 20: Prostate‐related events (sensitivity analysis)
1.21
1.21. Analysis
Comparison 1: Testosterone versus placebo (short‐term), Outcome 21: Lower urinary tract symptoms (sensitivity analysis)
2.1
2.1. Analysis
Comparison 2: Testosterone versus placebo (long‐term), Outcome 1: Erectile function (IIEF‐EF)
2.2
2.2. Analysis
Comparison 2: Testosterone versus placebo (long‐term), Outcome 2: Treatment withdrawal due to adverse events
3.1
3.1. Analysis
Comparison 3: Testosterone versus PDE5I (short‐term) , Outcome 1: Erectile function (IIEF‐5)
3.2
3.2. Analysis
Comparison 3: Testosterone versus PDE5I (short‐term) , Outcome 2: Sexual quality of life (AMS total)
3.3
3.3. Analysis
Comparison 3: Testosterone versus PDE5I (short‐term) , Outcome 3: Prostate‐related events
4.1
4.1. Analysis
Comparison 4: Testosterone + PDE5I versus PDE5I (short‐term), Outcome 1: Erectile function
4.2
4.2. Analysis
Comparison 4: Testosterone + PDE5I versus PDE5I (short‐term), Outcome 2: Erectile function (conversion to IIEF‐EF)
4.3
4.3. Analysis
Comparison 4: Testosterone + PDE5I versus PDE5I (short‐term), Outcome 3: Sexual quality of life (IIEF ‐ overall satisfaction)
4.4
4.4. Analysis
Comparison 4: Testosterone + PDE5I versus PDE5I (short‐term), Outcome 4: Sexual quality of life (AMS total)
4.5
4.5. Analysis
Comparison 4: Testosterone + PDE5I versus PDE5I (short‐term), Outcome 5: Treatment withdrawal due to adverse events
4.6
4.6. Analysis
Comparison 4: Testosterone + PDE5I versus PDE5I (short‐term), Outcome 6: Prostate‐related events
4.7
4.7. Analysis
Comparison 4: Testosterone + PDE5I versus PDE5I (short‐term), Outcome 7: Erectile function (subgroup: metabolic syndrome (MS), conversion to IIEF‐EF)
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    1. NCT03518034. A study to evaluate the effect of testosterone replacement therapy (TRT) on the incidence of major adverse cardiovascular events (MACE) and efficacy measures in hypogonadal men (TRAVERSE). clinicaltrials.gov/show/NCT03518034 (first received 3 May 2018).
    1. Pencina KM, Travison TG, Cunningham GR, Lincoff AM, Nissen SE, Khera M, et al. Effect of testosterone replacement therapy on sexual function and hypogonadal symptoms in men with hypogonadism. Journal of Clinical Endocrinology & Metabolism 2023 Aug 17 [Epub ahead of print]. [DOI: 10.1210/clinem/dgad484] - DOI - PubMed
Lu 2003 {published data only}
    1. Lu J, Xia S, Fan J, Zhu J, Lin GM. The prospective and randomized control study of Viagra combined with Andriol in the treatment of ED in the aging male. Chinese Journal of Andrology 17;3:194-6.
Lunglmayr 1980 {published data only}
    1. Lunglmayr G, Stellamor M, Spona J. Androgen therapy of impotentia coeundi in elderly men. Psychological and endocrinological investigations. Wiener Klinische Wochenschrift 1980;92(7):243-247 1980;92(7):243-7. - PubMed
Maggi 2016 {published data only}
    1. Maggi M, Heiselman D, Knorr J, Iyengar S, Paduch DA, Donatucci C. Testosterone solution 2% for erectile, orgasmic and ejaculatory dysfunction in hypogonadal men. Journal of Sexual Medicine 2016;13(5 Suppl 1):S14. - PubMed
    1. Maggi M, Heiselman D, Knorr J, Iyengar S, Paduch DA, Donatucci CF. Impact of testosterone solution 2% on ejaculatory dysfunction in hypogonadal men. Journal of Sexual Medicine 2016;13(8):1220-6. [DOI: 10.1016/j.jsxm.2016.05.012] - DOI - PubMed
Merza 2006 {published data only}
    1. Merza Z, Blumsohn A, Mah PM, Meads DM, McKenna SP, Wylie K, et al. Double-blind placebo-controlled study of testosterone patch therapy on bone turnover in men with borderline hypogonadism. International Journal of Andrology 2006;29(3):381-91. [DOI: 10.1111/j.1365-2605.2005.00612.x] - DOI - PubMed
Morales 2009 {published data only}
    1. Morales A, Black A, Emerson L, Barkin J, Kuzmarov I, Day A. Androgens and sexual function: a placebo-controlled, randomized, double-blind study of testosterone vs. dehydroepiandrosterone in men with sexual dysfunction and androgen deficiency. Aging Male 2009;12(4):104-12. [DOI: 10.3109/13685530903294388] - DOI - PubMed
    1. NCT00202163. ANDRO 2002: dehydroepiandrosterone (DHEA) or testosterone versus placebo in men with sexual dysfunction. clinicaltrials.gov/show/NCT00202163 (first received 13 September 2005).
Paduch 2015 {published data only}
    1. NCT01419236. A study of ejaculatory dysfunction in men with low testosterone levels. clinicaltrials.gov/show/NCT01419236 (first received 16 August 2011).
    1. Paduch DA, Polzer P, Ni X, Basaria S. Effect of testosterone solution 2% for the treatment of ejaculatory dysfunction in androgen-deficient men. Journal of Sexual Medicine 2015;12(Suppl 2):101-2.
    1. Paduch DA, Polzer P, Ni X, Basaria S. Effect of testosterone solution 2% for the treatment of ejaculatory dysfunctions in androgen deficient men. Journal of Sexual Medicine 2015;12(Suppl 2):182.
    1. Paduch DA, Polzer PK, Ni X, Basaria S. Testosterone replacement in androgen-deficient men with ejaculatory dysfunction: a randomized controlled trial. Journal of Clinical Endocrinology and Metabolism 2015;100(8):2956-62. [DOI: 10.1210/jc.2014-4434] - DOI - PubMed
Rao 2023 {published data only}
    1. Rao PM, Jones TH, Kelly D. Testosterone improves symptom severity, quality of life (QOL), triglycerides and strength: a randomised placebo-controlled study in men with uncontrolled type-2 diabetes and hypogonadism: Stride study. Diabetic Medicine 2023;40(Suppl 1):184. [DOI: 10.1111/dme.15048] - DOI
Reiter 1999 {published data only}
    1. Reiter W J, Pycha A, Schatzl G, Pokorny A, Gruber D M, Huber J C, et al. Dehydroepiandrosterone in the treatment of erectile dysfunction: a prospective, double-blind, randomized, placebo-controlled study. Urology 1999;53(3):590-4; discussion 594-5. [PMID: ] - PubMed
Roth 2011 {published data only}
    1. Roth LW, Schwartz RS, Meacham RB. The impact of testosterone supplementation on sexual function in elderly men. Fertility and Sterility 2011;96(3 Suppl 1):S1-2. [DOI: 10.1016/j.fertnstert.2011.07.014] - DOI
Schiavi 1997 {published data only}
    1. Schiavi RC, White D, Mandeli J, Levine AC. Effect of testosterone administration on sexual behavior and mood in men with erectile dysfunction. Archives of Sexual Behavior 1997;26(3):231-41. [PMID: ] - PubMed
Seftel 2004 {published data only}
    1. Seftel AD, Mack RJ, Secrest AR, Smith TM. Restorative increases in serum testosterone levels are significantly correlated to improvements in sexual functioning. Journal of Andrology 2004;25(6):963-72. [PMID: ] - PubMed
    1. Steidle C, Schwartz S, Jacoby K, Sebree T, Smith T, Bachand R. AA2500 testosterone gel normalizes androgen levels in aging males with improvements in body composition and sexual function. Journal of Clinical Endocrinology and Metabolism 2003;88(6):2673-81. [DOI: 10.1210/jc.2002-021058] - DOI - PubMed
Shabsigh 2004a {published data only}
    1. Burnett AL, Kan-Dobrosky N, Miller MG. Testosterone replacement with 1% testosterone gel and priapism: no definite risk relationship. Journal of Sexual Medicine 2013;10(4):1151-61. [DOI: 10.1111/jsm.12059] - DOI - PubMed
    1. Burnett AL, Miller M, Kan-Dobrosky N. Testosterone replacement and priapism risk: no definite relationship. Journal of Sexual Medicine 2012;9:20. [DOI: 10.1111/j.1743-6109.2012.02633.x] - DOI - PubMed
    1. Shabsigh R, Kaufman JM, Steidle C, Padma-Nathan H. Randomized study of testosterone gel as adjunctive therapy to sildenafil in hypogonadal men with erectile dysfunction who do not respond to sildenafil alone. Journal of Urology 2004;172(2):658-63. [DOI: 10.1097/01.ju.0000132389.97804.d7] - DOI - PubMed
    1. Shabsigh R, Kaufman JM, Steidle C, Padma-Nathan H. Randomized study of testosterone gel as adjunctive therapy to sildenafil in hypogonadal men with erectile dysfunction who do not respond to sildenafil alone. Journal of Urology 2008;179(5 Suppl):S97-102. [DOI: 10.1016/j.juro.2008.03.145] - DOI - PubMed
Snyder 2016 {published data only}
    1. Abd Alamir M, Ellenberg SS, Swerdloff RS, Wenger NK, Mohler ER, Lewis CE, et al. The cardiovascular trial of the testosterone trials: rationale, design, and baseline data of a clinical trial using computed tomographic imaging to assess the progression of coronary atherosclerosis. Coronary Artery Disease 2016;27(2):95-103. [DOI: 10.1097/MCA.0000000000000321] - DOI - PMC - PubMed
    1. Budoff MJ, Ellenberg SS, Lewis CE, Mohler ER, Wenger NK, Bhasin S, et al. Testosterone treatment and coronary artery plaque volume in older men with low testosterone. JAMA 2017;317(7):708-16. [DOI: 10.1001/jama.2016.21043] - DOI - PMC - PubMed
    1. Cunningham GR, Stephens-Shields AJ, Rosen RC, Wang C, Bhasin S, Matsumoto AM, et al. Testosterone treatment and sexual function in older men with low testosterone levels. Journal of Clinical Endocrinology & Metabolism 2016;101(8):3096-104. [DOI: 10.1210/jc.2016-1645] - DOI - PMC - PubMed
    1. NCT00799617. The testosterone trials in older men. clinicaltrials.gov/ct2/show/study/NCT00799617 (first received 26 November 2008).
    1. Snyder PJ, Bhasin S, Cunningham GR, Matsumoto AM, Stephens-Shields AJ, Cauley JA, et al. Effects of testosterone treatment in older men. New England Journal of Medicine 2016;374(7):611-24. - PMC - PubMed
Spitzer 2012 {published data only}
    1. NCT00512707. Effect of testosterone in men with erectile dysfunction. clinicaltrials.gov/show/NCT00512707 (first received 7 August 2007).
    1. Spitzer M, Basaria S, Travison TG, Davda MN, DeRogatis L, Bhasin S. The effect of testosterone on mood and well-being in men with erectile dysfunction in a randomized, placebo-controlled trial. Andrology 2013;1(3):475-82. [DOI: 10.1111/j.2047-2927.2013.00075.x] - DOI - PMC - PubMed
    1. Spitzer M, Basaria S, Travison TG, Davda MN, Paley A, Cohen B, et al. Effect of testosterone replacement on response to sildenafil citrate in men with erectile dysfunction: a parallel, randomized trial. Annals of Internal Medicine 2012;157(10):681-91. [DOI: 10.7326/0003-4819-157-10-201211200-00004] - DOI - PubMed
    1. Spitzer MJ, Basaria S, Davda MN, Travison TG, Paley A, Kaplan B, et al. Effect of testosterone replacement on response to sildenafil citrate in men with erectile dysfunction: a randomized, placebo-controlled trial. Endocrine Reviews 2012;33(Suppl 1):i726. [DOI: 10.1093/edrv/33.supp.1] - DOI
Yucel 2017 {published data only}
    1. Yucel C, Keskin MZ, Peskircioglu CL. The effect of transdermal testosterone administration on lower urinary tract symptoms and erectile dysfunction: a prospective, randomized, placebo-controlled trial. Current Urology 2017;11(1):4-8. [DOI: 10.1159/000447187] - DOI - PMC - PubMed
Zhang 2012 {published data only}
    1. Zhang E, Zhang B, Chen J, Zang Z, Qi T. Sildenafil plus undecanoate and sildenafil alone in the treatment of type 2 diabetic patients with erectile dysfunction. Heart 2012;98:E154-5. [DOI: 10.1136/heartjnl-2012-302920g.2] - DOI
Zhong 2013 {published data only}
    1. Zhong J, Liang G, Li P, Dai J, Xu D, Ping P, Li Z. A multicenter research of sildenafil combined with testosterone undecanoate for treatment of erectile dysfunction with diabetes. Chinese Journal of Andrology 2013;27(4):26-9.

References to studies excluded from this review

Amiaz 2011 {published data only}
    1. Amiaz R, Pope H, Seidman SN, Weiser M. Testosterone gel replacement improves sexual function in hypogonadal depressed men taking antidepressants. European Neuropsychopharmacology 2010;20(Suppl 3):S374.
    1. Amiaz R, Pope HG, Mahne T, Kelly JF, Brennan BP, Kanayama G, et al. Testosterone gel replacement improves sexual function in depressed men taking serotonergic antidepressants: a randomized, placebo-controlled clinical trial. Journal of Sex & Marital Therapy 2011;37(4):243-54. [DOI: 10.1080/0092623X.2011.582425] - DOI - PubMed
    1. Seidman S, Pope H, Amiaz R, Weiser M. Testosterone gel replacement improves sexual function in depressed men taking serotonergic antidepressants: a randomized, placebo-controlled clinical trial. Gender Medicine 2010;7(5):529. - PubMed
Atkinson 2010 {published data only}
    1. Atkinson RA, Srinivas-Shankar U, Roberts SA, Connolly MJ, Adams JE, Oldham JA, et al. Effects of testosterone on skeletal muscle architecture in intermediate-frail and frail elderly men. Journals of Gerontology. Series A, Biological Sciences and Medical Sciences 2010;65(11):1215-9. [DOI: 10.1093/gerona/glq118] - DOI - PubMed
Aversa 2012 {published data only}
    1. Aversa A, Francomano D, Bruzziches R, Radicioni A, Anzuini A, Romanelli F, et al. CAG repeat length and arterial reactivity after acute testosterone gel administration in men with severe hypogonadism. Journal of Sexual Medicine 2012;9:321.
Bakhshi 2000 {published data only}
    1. Bakhshi V, Elliott M, Gentili A, Godschalk M, Mulligan T. Testosterone improves rehabilitation outcomes in ill older men. Journal of the American Geriatrics Society 2000;48(5):550-3. [DOI: ] - PubMed
Basaria 2010 {published data only}
    1. Basaria S, Coviello AD, Travison TG, Storer TW, Farwell WR, Jette AM, et al. Adverse events associated with testosterone administration. New England Journal of Medicine 2010;363(2):109-22. [DOI: 10.1056/NEJMoa1000485] - DOI - PMC - PubMed
Basaria 2013 {published data only}
    1. Basaria S, Davda MN, Travison TG, Ulloor J, Singh R, Bhasin S. Risk factors associated with cardiovascular events during testosterone administration in older men with mobility limitation. Journals of Gerontology. Series A, Biological Sciences and Medical Sciences 2013;68(2):153-60. [DOI: 10.1093/gerona/gls138] - DOI - PMC - PubMed
Basaria 2015 {published data only}
    1. Basaria S, Harman SM, Travison TG, Hodis H, Tsitouras P, Budoff M, et al. Effects of testosterone administration for 3 years on subclinical atherosclerosis progression in older men with low or low-normal testosterone levels: a randomized clinical trial. JAMA 2015;314(6):570-81. [DOI: 10.1001/jama.2015.8881] - DOI - PubMed
    1. Bhasin S, Travison TG, O'Brien L, Mackrell J, Krishnan V, Ouyang H, et al. Contributors to the substantial variation in on-treatment testosterone levels in men receiving transdermal testosterone gels in randomized trials. Andrology 2017;6(1):151-7. [DOI: 10.1111/andr.12428] - DOI - PubMed
    1. NCT00240981. TOM: Testosterone in older men with sarcopenia. clinicaltrials.gov/show/NCT00240981 (first received 14 October 2005).
Bokhamada 2013 {published data only}
    1. Bokhamada HK, Dalton CF, Woodroofe MN, Stanworth RD, Jones TH. The effect of testosterone replacement therapy on serum pro-and anti-inflammatory biomarkers and apolipoprotein levels in hypogonadal men with diabetes. Obesity Facts 2013;6:141. [DOI: 10.1159/000170983] - DOI
Borst 2014 {published data only}
    1. Borst SE, Yarrow JF, Conover CF, Nseyo U, Meuleman JR, Lipinska JA, et al. Musculoskeletal and prostate effects of combined testosterone and finasteride administration in older hypogonadal men: a randomized, controlled trial. American Journal of Physiology-Endocrinology and Metabolism 2014;306(4):E433-42. [DOI: 10.1152/ajpendo.00592.2013] - DOI - PMC - PubMed
Botha 2017 {published data only}
    1. Botha J, Velling Magnussen L, Nielsen MH, Nielsen TB, Højlund K, Andersen MS, et al. Microvesicles correlated with components of metabolic syndrome in men with type 2 diabetes mellitus and lowered testosterone levels but were unaltered by testosterone therapy. Journal of Diabetes Research 2017;2017:4257875. [DOI: 10.1155/2017/4257875] - DOI - PMC - PubMed
    1. NCT01560546. Testosterone therapy of men with type 2 diabetes mellitus (T2DM). ClinicalTrials.gov/show/NCT01560546 (first received 20 March 2012).
Brown 2000 {published data only}
    1. Brown GA, Vukovich MD, Reifenrath TA, Uhl NL, Parsons KA, Sharp RL, et al. Effects of anabolic precursors on serum testosterone concentrations and adaptations to resistance training in young men. International Journal of Sport Nutrition and Exercise Metabolism 2000;10(3):340-59. [PMID: ] - PubMed
Butrova 1971 {published data only}
    1. Butrova SA, Kogan BS. The effectiveness of sex hormone replacement therapy in male hypogonadism. Problems of Endocrinology (Mosk) 1971;17(5):43-7. - PubMed
Buvat 2009 {published data only}
    1. Buvat J, Arver S, Behre H, Meuleman E, Moncada I, Morales M, et al. A placebo controlled study of the effects on insulin sensitivity and sexual function of transdermal testosterone gel in hypogonadal men with type II diabetes and/or metabolic syndrome: data from the times 2 study. Journal of Sexual Medicine 2009;6:56-7. [DOI: 10.1111/j.1743-6109.2008.01125-1.x] - DOI
Carson 2016 {published data only}
    1. Carson III C, Khera M, Dobs A, Wang C, Kaminetsky J, Miner M, et al. Hypogonadal men with sexual function disorder benefit from LPCN 1021 (oral testosterone)-SOAR (study of androgen replacement) trial. Journal of Urology 2016;195(4 Suppl):e1010-1. [DOI: 10.1016/j.juro.2016.02.1861] - DOI
Cherrier 2005 {published data only}
    1. Cherrier MM, Matsumoto AM, Amory JK, Ahmed S, Bremner W, Peskind ER, et al. The role of aromatization in testosterone supplementation: effects on cognition in older men. Neurology 2005;64(2):290-6. [DOI: 10.1212/01.WNL.0000149639.25136.CA] - DOI - PubMed
Cho 2016 {published data only}
    1. Cho DY, Yeo JK, Cho SI, Jung JE, Yang SJ, Kong DH, et al. Exercise improves the effects of testosterone replacement therapy and the durability of response after cessation of treatment: a pilot randomized controlled trial. Asian Journal of Andrology 2017;19(5):602-7. [DOI: 10.4103/1008-682X.184269] - DOI - PMC - PubMed
Christensen 2023 {published data only}
    1. Christensen LL, Poulsen HE, Andersen MS, Glintborg D. Whole-body oxidative stress reduction during testosterone therapy in aging men: A randomized placebo-controlled trial. Andrology 2023 May 13 [Epub ahead of print]. [DOI: 10.1111/andr.13458] - DOI - PubMed
Clague 1999 {published data only}
    1. Clague JE, Wu FC, Horan MA. Difficulties in measuring the effect of testosterone replacement therapy on muscle function in older men. International Journal of Andrology 1999;22(4):261-5. [PMID: ] - PubMed
Crawford 2003 {published data only}
    1. Crawford BA, Liu PY, Kean MT, Bleasel JF, Handelsman DJ. Randomized placebo-controlled trial of androgen effects on muscle and bone in men requiring long-term systemic glucocorticoid treatment. Journal of Clinical Endocrinology & Metabolism 2003;88(7):3167-76. [DOI: 10.1210/jc.2002-021827] - DOI - PubMed
Del Fabbro 2013 {published data only}
    1. Del Fabbro E, Garcia J, DeBakey ME, Dev R, Palmer L. A double-blind placebo controlled trial of testosterone replacement for fatigue in males with advanced cancer (TH307-B). Journal of Pain and Symptom Management 2013;45(2):336-7. [DOI: 10.1016/j.jpainsymman.2012.10.039] - DOI
    1. Del Fabbro E, Garcia J, Dev R, Palmer J L, Klingner-Winton C, Roberts L E, et al. A randomized placebo-controlled trial of testosterone replacement for fatigue in male hypogonadic patients with advanced cancer. Journal of Clinical Oncology 2011;29(15 Suppl 1):TPS238. [DOI: 10.1200/jco.2011.29.15_suppl.tps238] - DOI
    1. Del Fabbro E, Garcia J, Dev R, Pulivarthi K, Palmer L, Bruera E. Testosterone replacement for fatigue in male hypogonadic patients with advanced cancer: a preliminary double-blind, placebo-controlled trial. Supportive Care in Cancer 2012;20:S249-50. [DOI: 10.1007/s00520-012-1479-7] - DOI - PubMed
    1. Del Fabbro E, Garcia JM, Dev R, Hui D, Williams J, Engineer D, et al. Testosterone replacement for fatigue in hypogonadal ambulatory males with advanced cancer: a preliminary double-blind placebo-controlled trial. Supportive Care in Cancer 2013;21(9):2599-607. [DOI: 10.1007/s00520-013-1832-5] - DOI - PubMed
Dudek 2020 {published data only}
    1. Dudek P, Kozakowski J, Zgliczyński W. The effects of testosterone replacement therapy in men with age-dependent hypogonadism on body composition, and serum levels of leptin, adiponectin, and C-reactive protein. Endokrynologia Polska 2020;71(5):382-7. [10.5603/EP.a2020.0048] - PubMed
Emmelot‐Vonk 2009 {published data only}ISRCTN23688581
    1. Emmelot-Vonk MH, Verhaar HJ, Nakhai Pour HR, Aleman A, Lock TM, Bosch JL, et al. Effect of testosterone supplementation on functional mobility, cognition, and other parameters in older men: a randomized controlled trial. JAMA 2008;299(1):39-52. [DOI: 10.1001/jama.2007.51.] - DOI - PubMed
    1. Emmelot-Vonk MH, Verhaar HJ, Nakhai-Pour HR, Grobbee DE, Schouw YT. Effect of testosterone supplementation on sexual functioning in aging men: a 6-month randomized controlled trial. International Journal of Impotence Research 2009;21(2):129-38. [DOI: 10.1038/ijir.2009.5] - DOI - PubMed
    1. ISRCTN23688581. The effects of long term testosterone supplementation in testosterone deficient men on quality of life, sarcopenia, cognitive function, obesity and vascular ageing. www.isrctn.com/ISRCTN23688581 (first received 16 May 2005).
English 2000 {published data only}
    1. English KM, Steeds RP, Jones TH, Diver MJ, Channer KS. Low-dose transdermal testosterone therapy improves angina threshold in men with chronic stable angina: a randomized, double-blind, placebo-controlled study. Circulation 2000;102(16):1906-11. [PMID: ] - PubMed
Fernández‐García 2022 {published data only}
    1. Fernández-García JC, Barrios-Rodríguez R, Asenjo-Plaza M, Ramos-Molina B, Molina-Vega M, Guzmán-Guzmán A, et al. Metformin, testosterone, or both in men with obesity and low testosterone: a double-blind, parallel-group, randomized controlled trial. Metabolism 2022;136:155290. [DOI: 10.1016/j.metabol.2022.155290] - DOI - PubMed
Fernández‐Lázaro 2021 {published data only}
    1. Fernández-Lázaro D, Mielgo-Ayuso J, Del Valle Soto M, Adams DP, González-Bernal JJ, Seco-Calvo J. The effects of 6 weeks of Tribulus terrestris L. supplementation on body composition, hormonal response, perceived exertion, and crossfit® performance: a randomized, single-blind, placebo-controlled study. Nutrients 2021;13(11):3969. [DOI: 10.3390/nu13113969] - DOI - PMC - PubMed
Fontenot 2014 {published data only}
    1. Fontenot G, Podolski J. Oral enclomid (androxal) raises free and total serum testosterone in hypogonadal men: comparison with a topical gel. Journal of Sexual Medicine. 2014;11:162.
Frederiksen 2012 {published data only}
    1. Frederiksen L, Højlund K, Hougaard DM, Mosbech TH, Larsen R, Flyvbjerg A, et al. Testosterone therapy decreased adiponectin and subcutaneous fat in aging men. Endocrine Reviews 2011;32(Suppl 1):2544. [DOI: 10.1093/edrv/32.supp.1] - DOI
    1. Frederiksen L, Højlund K, Hougaard DM, Mosbech TH, Larsen R, Flyvbjerg A, et al. Testosterone therapy decreases subcutaneous fat and adiponectin in aging men. European Journal of Endocrinology 2012;166(3):469-76. [DOI: 10.1530/EJE-11-0565] - DOI - PubMed
Fui 2017 {published data only}
    1. Fui MNT, Hoermann R, Nolan B, Michelle C, Jeffrey DZ, Mathis G. Effect of testosterone treatment on bone remodelling markers and mineral density in obese dieting men in a randomized clinical trial. Scientific Reports 2018;8(1):9099. - PMC - PubMed
    1. Fui MNT, Hoermann R, Prendergast L, Zajac JD, Grossmann M. Symptomatic response to testosterone treatment in dieting obese men with low testosterone levels in a randomized, placebo-controlled clinical trial. Endocrine Reviews 2017;38(Suppl 1):420-6. - PubMed
    1. Fui MNT, Hoermann R, Prendergast LA, Zajac JD, Grossmann M. Symptomatic response to testosterone treatment in dieting obese men with low testosterone levels in a randomized, placebo-controlled clinical trial. International Journal of Obesity 2017;41(3):420-6. [DOI: 10.1038/ijo.2016.242] - DOI - PubMed
    1. Fui MNT, Prendergast LA, Dupuis P, Zajac JD, Grossmann M. Dieting but not testosterone treatment improves androgen deficiency-like symptoms in obese men with lowered testosterone. Clinical Endocrinology 2017;86:15. [DOI: 10.1111/cen.13259] - DOI
    1. NCT01616732. Testosterone and weight loss. clinicaltrials.gov/ct2/show/NCT01616732 (first received 8 June 2012).
Gianatti 2014 {published data only}
    1. Gianatti EJ, Dupuis P, Hoermann R, Zajac JD, Grossmann M. Effect of testosterone treatment on constitutional and sexual symptoms in men with type 2 diabetes in a randomized, placebo-controlled clinical trial. Journal of Clinical Endocrinology and Metabolism 2014;99(10):3821-8. [DOI: 10.1210/jc.2014-1872] - DOI - PubMed
Gluud 1988 {published data only}
    1. Gluud C, Wantzin P, Eriksen J. No effect of oral testosterone treatment on sexual dysfunction in alcoholic cirrhotic men. Gastroenterology 1988;95(6):1582-7. [PMID: ] - PubMed
Gomaa 2006 {published data only}
    1. Gomaa AA, Hamed HA. Improvement of sexual function in partial testosterone-deficient ageing men treated with cream containing testosterone and vasoactive agents. Journal of Men's Health & Gender 2006;3(1):47-55. [DOI: 10.1016/j.jmhg.2004.12.013] - DOI
Gonzalez 2021 {published data only}
    1. Gonzalez D, Kresch E, Ory J, Nackeeran S, Blachman-Braun R, Ramasamy R. Impact of testosterone therapy on polycythemia: evaluation of data from two ongoing open-label randomized single-center clinical trials. Fertility and Sterility 2021;116(3):e347. [DOI: 10.1016/j.fertnstert.2021.07.931] - DOI
Gregori 2021 {published data only}
    1. Gregori G, Celli A, Barnouin Y, Paudyal A, Armamento-Villareal R, Napoli N, et al. Cognitive response to testosterone replacement added to intensive lifestyle intervention in older men with obesity and hypogonadism: prespecified secondary analyses of a randomized clinical trial. American Journal of Clinical Nutrition 2021;114(5):1590-9. [DOI: 10.1093/ajcn/nqab253] - DOI - PMC - PubMed
Hackett 2019 {published data only}
    1. Hackett G, Cole N, Mulay A, Strange RC, Ramachandran S. Long-term testosterone therapy in type 2 diabetes is associated with decreasing waist circumference and improving erectile function. World Journal of Men's Health 2020;38(1):68-77. [DOI: 10.5534/wjmh.180052M] - DOI - PMC - PubMed
    1. Hackett G, Cole N, Mulay A, Strange RC, Ramachandran S. Long-term testosterone therapy in type 2 diabetes is associated with reduced mortality without improvement in conventional cardiovascular risk factors. BJU International 2019;123(3):519-29. [DOI: 10.1111/bju.14536] - DOI - PubMed
Harikai 2018 {published data only}
    1. Harikai S, Soh J, Kanemitsu N, Ochiai A, Ohnishi N, Ogura R, et al. Effects of testosterone replacement therapy on quality of life in patients with chronic kidney disease. International Journal of Urology 2018;25:250. [DOI: 10.1111/iju.13751] - DOI
Honig 2020 {published data only}
    1. Honig S, Jed K, Gittelman M, Swerdloff R, Danoff T, Dudley R. Treatment of hypogonadal men with oral testosterone undecanoate (TU) improves psycho-sexual, well-being and body composition parameters. Journal of Urology 2020;203:e547. [DOI: 10.1097/JU.0000000000000883.010] - DOI
    1. Seo BW, Swerdloff R, Amory J, Dobs A, Wang C, Danoff T, et al. New oral testosterone undecanoate (TU) formulation improves testosterone concentrations, as well as, psychosexual, well-being and body composition and bone desity parameters in hypogonadal men. Endocrine Practice 2020;26(Suppl 2):239.
    1. Swerdloff R, Honig S, Wang C, Gittelman M, Seo BW, Rohowsky N, et al. Two-year administration data of an oral testosterone undecanoate (TU) formulation in hypogonadal men. Journal of Sexual Medicine 2022;19(5):S128. [DOI: 10.1016/j.jsxm.2022.03.548] - DOI - PubMed
    1. Swerdloff R, Kavoussi P, Gittelman M, Wang C, Seo BW, Rohowsky N, et al. Safety analysis of an oral testosterone undecanoate (TU) formulation following 2 years of administration in hypogonadal men. Journal of Urology 2021;206(Suppl 3):e369-70. [DOI: 10.1097/JU.0000000000002009.07] - DOI
    1. Swerdloff R, Wang C, Amory JK, Gittelman M, Seo BW, Rohowsky N, et al. Safety analysis of an oral testosterone undecanoate (TU) formulation following 2 years of administration in hypogonadal men. Endocrine Practice 2021;27(6):S138. [DOI: 10.1016/j.eprac.2021.04.758] - DOI
JPRN‐jRCT1071210006 {published data only}
    1. JPRN-jRCT1071210006. Administration study on preparation of testosterone undecanoate to healthy adult males. rctportal.niph.go.jp/en/detail?trial_id=jRCT1071210006 (first received 7 April 2021).
Jung 2016 {published data only}
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Kogan 2023 {published data only}
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    1. Konaka H, Sugimoto K, Shigehara K, Mizokami A, Koh E, Namiki M. Androgen replacement therapy improved high-molecular weight adiponection status in patients with late-onset hypogonadism. Urology 2012;80(3 Suppl 1):S46. [DOI: 10.1016/S0090-4295%2812%2900880-1] - DOI
Konaka 2016 {published data only}
    1. Konaka H, Sugimoto K, Orikasa H, Iwamoto T, Takamura T, Takeda Y, et al. Effects of long-term androgen replacement therapy on the physical and mental statuses of aging males with late-onset hypogonadism: a multicenter randomized controlled trial in Japan (EARTH Study). Asian Journal of Andrology 2016;18(1):25-34. [DOI: 10.4103/1008-682X.148720] - DOI - PMC - PubMed
    1. Konaka H, Sugimoto K, Sigehara K, Kadono Y, Koh E, Namiki M. Effects of long-term androgen replacement therapy on physical and mental status in aging males with late-onset hypogonadism: results of a phase III, multicenter, randomized, controlled trial. Journal of Urology 2013;189(4 Suppl 1):e506. [DOI: 10.1016/j.juro.2013.02.2590] - DOI
    1. Shigehara K, Konaka H, Koh E, Izumi K, Kitagawa Y, Mizokami A, et al. Effects of testosterone replacement therapy on nocturia and quality of life in men with hypogonadism: a subanalysis of a previous prospective randomized controlled study in Japan. Aging Male 2015;18(3):169-74. [DOI: 10.3109/13685538.2015.1038990] - DOI - PubMed
    1. ShigeharaK, Konaka H, Kato Y, Iijima M, Nakashima K, Kawaguchi S, et al. Effect of testosterone replacement therapy on sexual function and glycemic control among hypogonadal men with type 2 diabetes mellitus. International Journal of Impotence Research 2019;31(1):25-30. [DOI: 10.1038/s41443-018-0065-z] - DOI - PubMed
Kuzmenko 2018 {published data only}
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Kwan 1983 {published data only}
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Lipshultz 2017 {published data only}
    1. Lipshultz L, Westfield G, Guidry M, Bryson N, Khera M. Clinical improvements in erectile function and mood in hypogonadal men treated with 4.5% nasal testosterone gel (natesto). Journal of Sexual Medicine 2018;15(2 Suppl 1):S79-80.
    1. Lipshultz L, Westfield G, Guidry M, Bryson N, Khera M. Clinical improvements in erectile function and mood in hypogonadal men treated with 4.5% nasal testosterone gel. Journal of Urology 2017;197(4 Suppl 1):e1346-7.
Melehan 2016 {published data only}
    1. Melehan K, Hoyos C, Yee B, Buchanan P, Grunstein R, Liu P. Increased sexual desire with exogenous testosterone administration in men with obstructive sleep apnea: an 18-week randomized double-blind placebo controlled study. Journal of Sleep Research 2011;20:15. - PMC - PubMed
    1. Melehan KL, Hoyos CM, Yee BJ, Buchanan PR, Grunstein RR, Liu PY. Increased sexual desire with testosterone administration in men with obstructive sleep apnea: an 18-week randomized double-blind placebo controlled study. Sleep and Biological Rhythms 2011;9(4):304. [DOI: 10.1111/j.1479-8425.2011.00518.x] - DOI - PMC - PubMed
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Mok 2020 {published data only}
    1. ACTRN12615000071527. Testosterone for androgen deficiency-like symptoms. anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12615000071527 (first received 9 January 2015).
    1. Mok SF, Fennell C, Savkovic S, Turner L, Jayadev V, Conway A, Handelsman DJ. Testosterone for androgen deficiency-like symptoms in men without pathologic hypogonadism: a randomized, placebo-controlled cross-over with masked choice extension clinical trial. Journals of Gerontology. Series A, Biological Sciences and Medical Sciences 2020;75(9):1723-31. [DOI: 10.1093/gerona/glz195] - DOI - PubMed
Nankin 1986 {published data only}
    1. Nankin HR, Lin T, Osterman J. Chronic testosterone cypionate therapy in men with secondary impotence. Fertility and Sterility 1986;46(2):300-7. - PubMed
Narukawa 2021 {published data only}
    1. Narukawa T, Soh J, Kanemitsu N, Harikai S, Fujihara A, Ukimura O. Efficacy of testosterone replacement therapy plus alternate-day tadalafil for patients with late-onset hypogonadism: an open-label, randomized, crossover study. International Journal of Urology 2021;28(4):376-81. [DOI: 10.1111/iju.14468] - DOI - PubMed
NCT00104572 {published data only}
    1. NCT00104572. Effects of aromatase inhibition versus testosterone in older men with low testosterone: randomized-controlled trial. clinicaltrials.gov/show/NCT00104572 (first received 1 March 2005).
NCT00161304 {published data only}
    1. NCT00161304. Study to determine the effects of testosterone replacement therapy in aging men with androgen deficiency. clinicaltrials.gov/show/NCT00161304 (first received 8 September 2005).
NCT00433199 {published data only}
    1. NCT00433199. Testosterone treatment for hypogonadal men. clinicaltrials.gov/show/NCT00433199 (first received 8 February 2007).
NCT01377103 {published data only}
    1. NCT01377103. Testosterone therapy in heart failure. clinicaltrials.gov/show/NCT01377103 (first received 18 May 2011).
NCT02712944 {published data only}
    1. NCT02712944. Testosterone replacement in renal failure. clinicaltrials.gov/show/NCT02712944 (first received 9 March 2016).
NCT02803073 {published data only}
    1. NCT02803073. Effect of testosterone replacement on exercise capacity in hypogonadal men after a recent myocardial infarction. clinicaltrials.gov/show/NCT02803073 (first received 8 June 2016).
NCT03851627 {published data only}
    1. NCT03851627. Effects of testosterone undecanoate vs placebo on intrahepatic fat content in overweight/obese men with T2DM or prediabetes and hypogonadism. clinicalTrials.gov/show/NCT03851627 (first received 14 January 2019).
NCT05484167 {published data only}
    1. NCT05484167. Natesto testosterone nasal gel for hypogonadal men. clinicalTrials.gov/show/NCT05484167 (first received 9 June 2022).
Park 2003 {published data only}
    1. Park NC, Yan BQ, Chung JM, Lee KM. Oral testosterone undecanoate (Andriol) supplement therapy improves the quality of life for men with testosterone deficiency. Aging Male 2003;6(2):86-93. [PMID: ] - PubMed
Park 2020a {published data only}
    1. Park HJ, Park JH, Park NC. Can testosterone therapy improve the treatment response of tadalafil in patients with BPH/LUTS and late onset hypogonadism? European Urology Open Science 2020;19:e135. [DOI: 10.1016/S2666-1683(20)32634-3] - DOI
Park 2020b {published data only}
    1. Park HJ, Park JH, Park NC. Effects of testosterone therapy on hypogonadal patients with obstructive sleep apnea syndrome: an open label randomized consecutive study. European Urology Open Science 2020;19:e133. [DOI: 10.1016/S2666-1683(20)32632-X] - DOI
Pasiakos 2019 {published data only}
    1. Pasiakos SM, Berryman CE, Karl J, Lieberman HR, Orr JS, Margolis LE, et al. Effects of testosterone supplementation on body composition and lower-body muscle function during severe exercise- and diet-induced energy deficit: a proof-of-concept, single centre, randomised, double-blind, controlled trial. EBioMedicine 2019;46:411-22. [DOI: 10.1016/j.ebiom.2019.07.059] - DOI - PMC - PubMed
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    1. Pedersen L, Christensen LL, Pedersen SM, Andersen M. Reduction of calprotectin and phosphate during testosterone therapy in aging men: a randomized controlled trial. Journal of Endocrinological Investigation 2017;40(5):529-38. [DOI: 10.1007/s40618-016-0597-3] - DOI - PubMed
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    1. Rastrelli G, Cipriani S, Lotti F, Cellai I, Comeglio P, Boddi V, et al. Testosterone replacement therapy is able to reduce prostate inflammation in men with BPH, metabolic syndrome and hypogonadism: preliminary results from a randomized placebo-controlled clinical trial. Journal of Sexual Medicine 2018;15(7):S160. [DOI: 10.1016/j.jsxm.2018.04.084] - DOI
Resnick 2017 {published data only}
    1. Resnick SM, Matsumoto AM, Stephens-Shields AJ, Ellenberg SS, Gill TM, Shumaker SA, et al. Testosterone treatment and cognitive function in older men with low testosterone and age-associated memory impairment. JAMA 2017;317(7):717-27. [DOI: 10.1001/jama.2016.21044] - DOI - PMC - PubMed
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    1. Seidman SN, Roose SP. The sexual effects of testosterone replacement in depressed men: randomized, placebo-controlled clinical trial. Journal of Sex and Marital Therapy 2006;32(3):267-73. [DOI: 10.1080/00926230600575355] - DOI - PubMed
    1. Seidman SN, Spatz E, Rizzo C, Roose SP. Testosterone replacement therapy for hypogonadal men with major depressive disorder: a randomized, placebo-controlled clinical trial. Journal of Clinical Psychiatry 2001;62(6):406-12. - PubMed
Shirai 2022 {published data only}
    1. Shirai M, Mizushima K, Tsuru T, Kurosawa M, Kure A, Uesaka Y, et al. Novel testosterone gel improves aging males' symptoms in patients with late-onset hypogonadism: active control equivalence, randomized, double-blind, crossover pilot study. Journal of Sexual Medicine 2022;19(5):S177. [DOI: 10.1016/j.jsxm.2022.03.403] - DOI - PubMed
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    1. Skakkebaek NE, Bancroft J, Davidson DW, Warner P. Androgen replacement with oral testosterone undecanoate in hypogonadal men: a double blind controlled study. Clinical Endocrinology 1981;14(1):49-61. [PMID: ] - PubMed
Srinivas‐Shankar 2010 {published data only}
    1. Srinivas-Shankar U, Roberts SA, Connolly MJ, O'Connell MD, Adams JE, Oldham JA, et al. Effects of testosterone on muscle strength, physical function, body composition, and quality of life in intermediate-frail and frail elderly men: a randomized, double-blind, placebo-controlled study. Journal of Clinical Endocrinology & Metabolism 2010;95(2):639-50. [DOI: 10.1210/jc.2009-1251] - DOI - PubMed
Traustadóttir 2018 {published data only}
    1. Traustadóttir T, Harman SM, Tsitouras P, Pencina KM, Li Z, Travison TG, et al. Long-term testosterone supplementation in older men attenuates age-related decline in aerobic capacity. Journal of Clinical Endocrinology & Metabolism 2018;103(8):2861-9. [DOI: 10.1210/jc.2017-01902] - DOI - PMC - PubMed
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    1. Wittert G, Bracken K, Robledo KP, Grossmann Mathis, Yeap BB, Handelsman DJ, et al. Testosterone treatment to prevent or revert type 2 diabetes in men enrolled in a lifestyle programme (T4DM): a randomised, double-blind, placebo-controlled, 2-year, phase 3b trial. Lancet Diabetes & Endocrinology 2021;9(1):32-45. [DOI: 10.1016/S2213-8587(20)30367-3] - DOI - PubMed
Wu 2020 {published data only}
    1. Wu M, Hao BJ, Liang WN, Li YZ, Geng Q, Shand XJ. Jiarong tablets combined with testosterone undecanoate capsules for late-onset hypogonadism in males: a multicentered clinical trial. Zhonghua Nan Ke Xue 2020;26(4):346-50. - PubMed
Yassin 2014 {published data only}
    1. Yassin DJ, Doros G, Hammerer PG, Yassin AA. Long-term testosterone treatment in elderly men with hypogonadism and erectile dysfunction reduces obesity parameters and improves metabolic syndrome and health-related quality of life. The Journal of Sexual Medicine 2014;11(6):1567-76. [https://dx.doi.org/10.1111/jsm.12523] - PubMed

References to studies awaiting assessment

NCT00163566 {published data only}
    1. NCT00163566. Study of DHT-Gel to treat the symptoms of low testosterone in men 55-80. clinicaltrials.gov/show/NCT00163566 (first received 9 September 2005).
NCT00185198 {published data only}
    1. NCT00185198. Efficacy and safety of testogel® in men with partial androgen deficiency of aging males (PADAM). clinicaltrials.gov/show/NCT00185198 (first received 9 September 2005).
NCT00254553 {published data only}
    1. NCT00254553. A study to test a measure of symptoms of older men with low testosterone on and off testosterone replacement treatment (P05815). clinicaltrials.gov/show/NCT00254553 (first received 14 November 2005).
NCT00349362 {published data only}
    1. NCT00349362. Testosterone for men with insulin treated type 2 diabetes. clinicaltrials.gov/show/NCT00349362 (first received 6 July 2006).
NCT00504712 {published data only}
    1. NCT00504712. Testosterone for peripheral vascular disease. clinicaltrials.gov/show/NCT00504712 (first received 19 July 2007).
NCT00710827 {published data only}
    1. NCT00710827. Nebido versus placebo in elderly men with typical symptoms of late onset hypogonadism over a period of 54 weeks. clinicaltrials.gov/show/NCT00710827 (first received 2 July 2008).
NCT01092858 {published data only}
    1. NCT01092858. NEBIDO in symptomatic late onset hypogonadism (SLOH). clinicaltrials.gov/show/NCT01092858 (first received 24 March 2010).
NCT01786473 {published data only}
    1. NCT01786473. Testogel (testosterone gel 50mg/5g) in the treatment of male hypogonadism. clinicaltrials.gov/show/NCT01786473 (first received 6 February 2013).

References to ongoing studies

Ioakeimidis 2021 {published data only}
    1. Ioakeimidis N, Angelis A, Rokkas K, Terentes-Printzios D, Saad F, Tousoulis D, et al. Effect of long-term testosterone replacement therapy on arterial stiffness and systemic endothelial function in male patients with hypogonadism. European Heart Journal 2021;42(Suppl 1):2832.
IRCT20181106041575N1 {published data only}
    1. IRCT20181106041575N1. Testosterone therapy in type 2 diabetes mellitus patients with erectile dysfunction. trialsearch.who.int/Trial2.aspx?TrialID=IRCT20181106041575N1 (first received 17 May 2019).
NCT03281187 {published data only}
    1. NCT03281187. Efficacy and safety of testosterone nasal gel for treating hypogonadism in men. clinicaltrials.gov/show/NCT03281187 (first received 11 September 2017).
Russo 2021 {published data only}
    1. Russo V, Colleluori G, Chen R, Mediwala S, Qualls C, Liebschner M, et al. Testosterone therapy and bone quality in men with diabetes and hypogonadism: study design and protocol. Contemporary Clinical Trials Communications 2021;21:100723. - PMC - PubMed

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