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Original Article

A randomized, double-blind, placebo-controlled trial of testosterone gel on body composition and health-related quality-of-life in men with hypogonadal to low-normal levels of serum testosterone and symptoms of androgen deficiency over 6 months with 12 months open-label follow-up

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Pages 198-207 | Received 07 Apr 2012, Accepted 30 May 2012, Published online: 26 Jul 2012

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Bruno Lunenfeld, George Mskhalaya, Michael Zitzmann, Giovanni Corona, Stefan Arver, Svetlana Kalinchenko, Yuliya Tishova & Abraham Morgentaler. (2021) Recommendations on the diagnosis, treatment and monitoring of testosterone deficiency in men. The Aging Male 24:1, pages 119-138.
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Thomas Greither, Carina Wenzel, Julia Jansen, Matthias Kraus, Martin Wabitsch & Hermann M. Behre. (2020) MiR-130a in the adipogenesis of human SGBS preadipocytes and its susceptibility to androgen regulation. Adipocyte 9:1, pages 197-205.
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Tom E. Nightingale, Pamela Moore, Joshua Harman, Refka Khalil, Ranjodh S. Gill, Teodoro Castillo, Robert A. Adler & Ashraf S. Gorgey. (2018) Body composition changes with testosterone replacement therapy following spinal cord injury and aging: A mini review. The Journal of Spinal Cord Medicine 41:6, pages 624-636.
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Giulia Rastrelli, Mauro Dicuio, Yacov Reismann, Alessandra Sforza, Mario Maggi & Giovanni Corona. (2018) Cardiovascular impact of testosterone therapy for hypogonadism. Expert Review of Cardiovascular Therapy 16:9, pages 617-625.
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Bruno Lunenfeld, George Mskhalaya, Michael Zitzmann, Stefan Arver, Svetlana Kalinchenko, Yuliya Tishova & Abraham Morgentaler. (2015) Recommendations on the diagnosis, treatment and monitoring of hypogonadism in men. The Aging Male 18:1, pages 5-15.
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Giovanni Corona, Elisa Maseroli, Giulia Rastrelli, Andrea M Isidori, Alessandra Sforza, Edoardo Mannucci & Mario Maggi. (2014) Cardiovascular risk associated with testosterone-boosting medications: a systematic review and meta-analysis. Expert Opinion on Drug Safety 13:10, pages 1327-1351.
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Yilmaz Aslan, Ozer Guzel, Melih Balci, Altug Tuncel, Muslum Yildiz & Ali Atan. (2014) The impact of metabolic syndrome on serum total testosterone level in patients with erectile dysfunction. The Aging Male 17:2, pages 76-80.
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Claire Pexman-Fieth, Hermann M. Behre, Alvaro Morales, Natalia Kan-Dobrosky & Michael G. Miller. (2014) A 6-month observational study of energy, sexual desire, and body proportions in hypogonadal men treated with a testosterone 1% gel. The Aging Male 17:1, pages 1-11.
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Bruno Lunenfeld, George Mskhalaya, Svetlana Kalinchenko & Yulia Tishova. (2013) Recommendations on the diagnosis, treatment and monitoring of late-onset hypogonadism in men – a suggested update. The Aging Male 16:4, pages 143-150.
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Josep Rodriguez-Tolrà, Josep Torremadé Barreda, Luis del Rio, Silvana di Gregorio & Eladio Franco Miranda. (2013) Effects of testosterone treatment on body composition in males with testosterone deficiency syndrome. The Aging Male 16:4, pages 184-190.
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Giovanni Corona, Giulia Rastrelli, Mauro Dicuio, Alessandra Sforza & Mario Maggi. (2017) Testosterone and Cardiovascular Diseases: Causes or Consequences: The Lesson from the Last 5 Years. Current Sexual Health Reports 9:4, pages 277-289.
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G Corona, M Dicuio, G Rastrelli, E Maseroli, F Lotti, A Sforza & M Maggi. (2023) Testosterone Treatment and Cardiovascular and Venous Thromboembolism Risk: What is ‘New’?. Journal of Investigative Medicine 65:6, pages 964-973.
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Grace E. Kohn, Taylor P. Kohn & Ranjith Ramasamy. (2017) Effects of Testosterone Replacement Therapy on Lower Urinary Tract Symptoms. Current Bladder Dysfunction Reports 12:2, pages 118-123.
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Y. Nian, M. Ding, S. Hu, H. He, S. Cheng, L. Yi, Y. Li & Y. Wang. (2017) Testosterone replacement therapy improves health-related quality of life for patients with late-onset hypogonadism: a meta-analysis of randomized controlled trials. Andrologia 49:4, pages e12630.
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G. Caleb Alexander, Geetha Iyer, Eleanor Lucas, Dora Lin & Sonal Singh. (2017) Cardiovascular Risks of Exogenous Testosterone Use Among Men: A Systematic Review and Meta-Analysis. The American Journal of Medicine 130:3, pages 293-305.
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Diana Martins, Zhan Yao, Mina Tadrous, Baiju R. Shah, David N. Juurlink, Muhammad M. Mamdani & Tara Gomes. (2017) The appropriateness and persistence of testosterone replacement therapy in Ontario. Pharmacoepidemiology and Drug Safety 26:2, pages 119-126.
Crossref
Abraham Morgentaler, M. Zitzmann, A. M. Traish, A. W. Fox, T. H. Jones, M. Maggi, S. Arver, A. Aversa, J.C.N. Chan, A. S. Dobs, G. I. Hackett, W. J. Hellstrom, P. Lim, B. Lunenfeld, G. Mskhalaya, C. C. Schulman & L. O. Torres. (2016) The consensus recommendations of a group of international experts on the fundamental concepts related to the issues of testosterone deficiency and its treatment.. Obesity and metabolism 13:3, pages 15-31.
Crossref
Peter Boyle, Alice Koechlin, Maria Bota, Alberto d'Onofrio, David G. Zaridze, Paul Perrin, John Fitzpatrick, Arthur L. Burnett & Mathieu Boniol. (2016) Endogenous and exogenous testosterone and the risk of prostate cancer and increased prostate-specific antigen (PSA) level: a meta-analysis. BJU International 118:5, pages 731-741.
Crossref
Andrew Cohen, Brittany Lapin, Chi H. Wang, Brian Helfand, David Victorson & Kristian Novakovic. (2016) Variation in Testosterone Levels and Health-related Quality of Life in Men Diagnosed With Prostate Cancer on Active Surveillance. Urology 94, pages 180-187.
Crossref
Abraham Morgentaler, Michael Zitzmann, Abdulmaged M. Traish, Anthony W. Fox, T. Hugh Jones, Mario Maggi, Stefan Arver, Antonio Aversa, Juliana C.N. Chan, Adrian S. Dobs, Geoffrey I. Hackett, Wayne J. Hellstrom, Peter Lim, Bruno Lunenfeld, George Mskhalaya, Claude C. Schulman & Luiz O. Torres. (2016) Fundamental Concepts Regarding Testosterone Deficiency and Treatment. Mayo Clinic Proceedings 91:7, pages 881-896.
Crossref
Taylor P. Kohn, Douglas A. Mata, Ranjith Ramasamy & Larry I. Lipshultz. (2016) Effects of Testosterone Replacement Therapy on Lower Urinary Tract Symptoms: A Systematic Review and Meta-analysis. European Urology 69:6, pages 1083-1090.
Crossref
Heather L. Gelhorn, Margaret K. Vernon, Katie D. Stewart, Michael G. Miller, Meryl Brod, Stanley E. Althof, Leonard R. DeRogatis, Adrian Dobs, Allen D. Seftel & Dennis A. Revicki. (2015) Content Validity of the Hypogonadism Impact of Symptoms Questionnaire (HIS-Q): A Patient-Reported Outcome Measure to Evaluate Symptoms of Hypogonadism. The Patient - Patient-Centered Outcomes Research 9:2, pages 181-190.
Crossref
CHANGCHENG GUO, WENYU GU, MIN LIU, BO PENG, XUDONG YAO, BIN YANG & JUNHUA ZHENG. (2016) Efficacy and safety of testosterone replacement therapy in men with hypogonadism: A meta-analysis study of placebo-controlled trials. Experimental and Therapeutic Medicine 11:3, pages 853-863.
Crossref
F Saad, A Yassin, G Doros & A Haider. (2015) Effects of long-term treatment with testosterone on weight and waist size in 411 hypogonadal men with obesity classes I-III: observational data from two registry studies. International Journal of Obesity 40:1, pages 162-170.
Crossref
John A. Batsis. 2016. Metabolic Syndrome. Metabolic Syndrome 665 678 .
Shin-ichi Hisasue. (2015) Contemporary perspective and management of testosterone deficiency: Modifiable factors and variable management. International Journal of Urology 22:12, pages 1084-1095.
Crossref
Matthias Kraus, Thomas Greither, Carina Wenzel, Daniela Bräuer-Hartmann, Martin Wabitsch & Hermann M. Behre. (2015) Inhibition of adipogenic differentiation of human SGBS preadipocytes by androgen-regulated microRNA miR-375. Molecular and Cellular Endocrinology 414, pages 177-185.
Crossref
Sabine Kliesch. (2015) Testosteronmangel im Alter: Normal oder pathologisch?. Deutsches Ärzteblatt Online.
Crossref
Abdulmaged M. Traish & Michael Zitzmann. (2015) The complex and multifactorial relationship between testosterone deficiency (TD), obesity and vascular disease. Reviews in Endocrine and Metabolic Disorders 16:3, pages 249-268.
Crossref
D. M. Kelly & T. H. Jones. (2015) Testosterone and obesity. Obesity Reviews 16:7, pages 581-606.
Crossref
L. Xu & C.M. Schooling. (2015) Differential risks in men and women for first and recurrent venous thrombosis: the role of genes and environment: comment. Journal of Thrombosis and Haemostasis 13:5, pages 884-886.
Crossref
Abraham Morgentaler, Martin M. Miner, Monica Caliber, Andre T. Guay, Mohit Khera & Abdulmaged M. Traish. (2015) Testosterone Therapy and Cardiovascular Risk: Advances and Controversies. Mayo Clinic Proceedings 90:2, pages 224-251.
Crossref
Eberhard Nieschlag. (2015) Current topics in testosterone replacement of hypogonadal men. Best Practice & Research Clinical Endocrinology & Metabolism 29:1, pages 77-90.
Crossref
John A. Batsis. 2014. Metabolic Syndrome. Metabolic Syndrome 1 17 .
Abdulmaged M. Traish. (2014) Testosterone and weight loss. Current Opinion in Endocrinology, Diabetes & Obesity 21:5, pages 313-322.
Crossref
Abdulmaged M. Traish. (2014) Adverse health effects of testosterone deficiency (TD) in men. Steroids 88, pages 106-116.
Crossref
Abdulmaged M. Traish. (2014) Outcomes of testosterone therapy in men with testosterone deficiency (TD): Part II. Steroids 88, pages 117-126.
Crossref
Fraser W. Gibb & Mark W.J. Strachan. (2014) Androgen deficiency and type 2 diabetes mellitus. Clinical Biochemistry 47:10-11, pages 940-949.
Crossref
Giovanni Corona, Andrea M. Isidori, Jaques Buvat, Antonio Aversa, Giulia Rastrelli, Geoff Hackett, Vincenzo Rochira, Alessandra Sforza, Andrea Lenzi, Edoardo Mannucci & Mario Maggi. (2014) Testosterone Supplementation and Sexual Function: A Meta-Analysis Study. The Journal of Sexual Medicine 11:6, pages 1577-1592.
Crossref
Nelson N. Stone, Martin Miner, Wendy L. Poage, Aditi Patel & E. David Crawford. (2014) Male Androgen Deficiency Syndrome Screening Questionnaire: A Simplified Instrument to Identify Testosterone-Deficient Men. Journal of Men's Health 11:1, pages 28-37.
Crossref
Aminu K. Bello, Peter Stenvinkel, Meng Lin, Brenda Hemmelgarn, Ravi Thadhani, Scott Klarenbach, Christopher Chan, Deborah Zimmerman, George Cembrowski, Giovanni Strippoli, Juan-Jesus Carrero & Marcello Tonelli. (2014) Serum Testosterone Levels and Clinical Outcomes in Male Hemodialysis Patients. American Journal of Kidney Diseases 63:2, pages 268-275.
Crossref
John Roger Andersen, Tor-Ivar Karlsen & Ronette L. Kolotkin. 2014. Integrative Weight Management. Integrative Weight Management 225 235 .
Farid Saad, Ahmad Haider, Gheorghe Doros & Abdulmaged Traish. (2013) Long‐term treatment of hypogonadal men with testosterone produces substantial and sustained weight loss. Obesity 21:10, pages 1975-1981.
Crossref
A. A. Yassin & G. Doros. (2013) Testosterone therapy in hypogonadal men results in sustained and clinically meaningful weight loss. Clinical Obesity 3:3-4, pages 73-83.
Crossref
Eberhard Nieschlag. (2013) Klinefelter Syndrome. Deutsches Ärzteblatt international.
Crossref
Michael Jay Schoenfeld, Emily Shortridge, Zhanglin Cui & David Muram. (2013) Medication Adherence and Treatment Patterns for Hypogonadal Patients Treated with Topical Testosterone Therapy: A Retrospective Medical Claims Analysis. The Journal of Sexual Medicine 10:5, pages 1401-1409.
Crossref
Peter T. K. Chan. 2013. Biennial Review of Infertility. Biennial Review of Infertility 31 48 .

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