A 6-month observational study of energy, sexual desire, and body proportions in hypogonadal men treated with a testosterone 1% gel

Aging Male

Volumn 17, Issue 1, 2014, Pages 1-11

  Pexman Fieth, Claire ^a   Behre, Hermann M ^b   Morales, Alvaro ^c   Kan Dobrosky, Natalia ^d   Miller, Michael G ^d  

^a ABBOTT GMBH AND CO KG   (Germany)

^b MARTIN LUTHER UNIVERSITÄT HALLE WITTENBERG   (Germany)

^c QUEEN S UNIVERSITY   (Canada)

^d ABBVIE INC   (United States)

Author keywords

Body composition; Erectile dysfunction; Fatigue; Hypogonadism; Quality of life; Testosterone replacement therapy

Indexed keywords

TESTOSTERONE;

ADULT; AGED; AGING MALES SYMPTOM SCALE; ARTICLE; BODY COMPOSITION; BODY IMAGE; BODY MASS; DRUG TOLERABILITY; ERECTILE DYSFUNCTION; FOLLOW UP; HUMAN; HYPOGONADISM; INTERNATIONAL INDEX OF ERECTILE FUNCTION; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTIDIMENSIONAL FATIGUE INVENTORY; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; OBSERVATIONAL STUDY; OPEN STUDY; PRIORITY JOURNAL; QUALITY OF LIFE; SEXUAL BEHAVIOR; TESTOSTERONE BLOOD LEVEL; VERY ELDERLY; WAIST CIRCUMFERENCE; YOUNG ADULT;

ADMINISTRATION, TOPICAL; ADULT; AGED; AGED, 80 AND OVER; ANDROGENS; BODY COMPOSITION; HUMANS; HYPOGONADISM; LIBIDO; MALE; MIDDLE AGED; PHYSICAL FITNESS; QUALITY OF LIFE; TESTOSTERONE; TREATMENT OUTCOME;

EID: 84896694384     PISSN: 13685538     EISSN: 14730790     Source Type: Journal    
DOI: 10.3109/13685538.2013.858113     Document Type: Article

References (47)

1. Bhasin S, Cunningham GR, Hayes FJ, et al. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2010;95: 2536-59.
2. Wang C, Nieschlag E, Swerdloff RS, et al. ISA, ISSAM, EAU, EAA and ASA recommendations: investigation, treatment and monitoring of late-onset hypogonadism in males. Aging Male 2009;12:5-12.
3. Heinemann LAJ, Zimmermann T, Vermeulen A, et al. A new 'aging males' symptoms' rating scale. Aging Male 1999;2:105-14.
4. Araujo AB, Esche GR, Kupelian V, et al. Prevalence of symptomatic androgen deficiency in men. J Clin Endocrinol Metab 2007;92: 4241-7.
5. Araujo AB, O'Donnell AB, Brambilla DJ, et al. Prevalence and incidence of androgen deficiency in middle-aged and older men: estimates from the Massachusetts Male Aging Study. J Clin Endocrinol Metab 2004;89:5920-6.
6. Harman SM, Metter EJ, Tobin JD, et al. Longitudinal effects of aging on serum total and free testosterone levels in healthy men. Baltimore Longitudinal Study of Aging. J Clin Endocrinol Metab 2001;86:724-31.
7. Mulligan T, Frick MF, Zuraw QC, et al. Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract 2006;60:762-9.
8. Travison TG, Shackelton R, Araujo AB, et al. The natural history of symptomatic androgen deficiency in men: onset, progression, and spontaneous remission. J Am Geriatr Soc 2008;56:831-9.
9. Ageing characterises the demographic perspectives of the European societies (Statistics in focus 72/2008). Luxembourg: Eurostat, European Communities; 2008. Available from: http://epp.eurostat. ec.europa.eu/portal/ page/portal/product-details/ publicationp-product-codeKS-SF-08-072 [last accessed 2 April 2013].
10. Maggi M, Schulman C, Quinton R, et al. The burden of testosterone deficiency syndrome in adult men: economic and quality-of-life impact. J Sex Med 2007;4:1056-69.
11. Kupelian V, Page ST, Araujo AB, et al. Low sex hormone-binding globulin, total testosterone, and symptomatic androgen deficiency are associated with development of the metabolic syndrome in nonobese men. J Clin Endocrinol Metab 2006;91:843-50.
12. Li C, Ford ES, Li B, et al. Association of testosterone and sex hormone-binding globulin with metabolic syndrome and insulin resistance in men. Diabetes Care 2010;33:1618-24.
13. Maggio M, Lauretani F, Ceda GP, et al. Association between hormones and metabolic syndrome in older Italian men. J Am Geriatr Soc 2006;54:1832-8.
14. Rodriguez A, Muller DC, Metter EJ, et al. Aging, androgens, and the metabolic syndrome in a longitudinal study of aging. J Clin Endocrinol Metab 2007;92:3568-72.
15. Nieschlag E, Swerdloff R, Behre HM, et al. Investigation, treatment, and monitoring of late-onset hypogonadism in males: ISA, ISSAM, and EAU recommendations. J Androl 2006;27:135-7.
16. Petak SM, Nankin HR, Spark RF, et al. American Association of Clinical Endocrinologists Medical Guidelines for clinical practice for the evaluation and treatment of hypogonadism in adult male patients-2002 update. Endocr Pract 2002;8:440-56.
17. Aversa A, Bruzziches R, Francomano D, et al. Effects of longacting testosterone undecanoate on bone mineral density in middleaged men with late-onset hypogonadism and metabolic syndrome: results from a 36 months controlled study. Aging Male 2012;15: 96-102.
18. Ho CC, Tong SF, Low WY, et al. A randomized, double-blind, placebo-controlled trial on the effect of long-acting testosterone treatment as assessed by the Aging Male Symptoms scale. BJU Int 2012;110:260-5.
19. Khera M, Bhattacharya RK, Blick G, et al. Improved sexual function with testosterone replacement therapy in hypogonadal men: real-world data from the Testim Registry in the United States (TRiUS). J Sex Med 2011;8:3204-13.
20. Miner MM, Bhattacharya RK, Blick G, et al. 12-Month observation of testosterone replacement effectiveness in a general population of men. Postgrad Med 2013;125:8-18.
21. Snyder PJ, Peachey H, Hannoush P, et al. Effect of testosterone treatment on bone mineral density in men over 65 years of age. J Clin Endocrinol Metab 1999;84:1966-72.
22. Wang C, Cunningham G, Dobs A, et al. Long-term testosterone gel (AndroGel) treatment maintains beneficial effects on sexual function and mood, lean and fat mass, and bone mineral density in hypogonadal men. J Clin Endocrinol Metab 2004;89:2085-98.
23. Wang C, Swerdloff RS, Iranmanesh A, et al. Transdermal testosterone gel improves sexual function, mood, muscle strength, and body composition parameters in hypogonadal men. J Clin Endocrinol Metab 2000;85:2839-53.
24. Shores MM, Smith NL, Forsberg CW, et al. Testosterone treatment and mortality in men with low testosterone levels. J Clin Endocrinol Metab 2012;97:2050-8.
25. Wang C, Alexander G, Berman N, et al. Testosterone replacement therapy improves mood in hypogonadal men - a clinical research center study. J Clin Endocrinol Metab 1996;81:3578-83.
26. AndroGel-(testosterone gel) 1% [prescribing information]. North Chicago, IL, USA: AbbVie Inc.; 2013. Available from: http:// www.rxabbvie.com/pdf/ androgel-PI.pdf [last accessed 6 November 2013].
27. Swerdloff RS, Wang C, Cunningham G, et al. Long-term pharmacokinetics of transdermal testosterone gel in hypogonadal men. J Clin Endocrinol Metab 2000;85:4500-10.
28. Wang C, Berman N, Longstreth JA, et al. Pharmacokinetics of transdermal testosterone gel in hypogonadal men: application of gel at one site versus four sites: a General Clinical Research Center Study. J Clin Endocrinol Metab 2000;85:964-9.
29. Behre HM, Heinemann L, Morales A, Pexman-Fieth C. Rationale, design and methods of the ESPRIT study: Energy, Sexual desire and body PropoRtions wIth AndroGel, Testosterone 1% gel therapy, in hypogonadal men. Aging Male 2008;11:101-6.
30. Rosen RC, Cappelleri JC, Gendrano III N. The International Index of Erectile Function (IIEF): a state-of-the-science review. Int J Impot Res 2002;14:226-44.
31. Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res 1995;39: 315-25.
32. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA 2001;285:2486-97.
33. Behre HM, Tammela TL, Arver S, et al. A randomized, doubleblind, 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. Aging Male 2012;15:198-207.
34. Heinemann LA, Moore C, Dinger JC, Stoehr D. Sensitivity as outcome measure of androgen replacement: the AMS scale. Health Qual Life Outcomes 2006;4:23-9.
35. Chiang HS, Hwang TI, Hsui YS, et al. Transdermal testosterone gel increases serum testosterone levels in hypogonadal men in Taiwan with improvements in sexual function. Int J Impot Res 2007;19: 411-17.
36. McNicholas TA, Dean JD, Mulder H, et al. A novel testosterone gel formulation normalizes androgen levels in hypogonadal men, with improvements in body composition and sexual function. BJU Int 2003;91:69-74.
37. Steidle C, Schwartz S, Jacoby K, et al. AA2500 testosterone gel normalizes androgen levels in aging males with improvements in body composition and sexual function. J Clin Endocrinol Metab 2003;88:2673-81.
38. Buvat J, Montorsi F, Maggi M, et al. Hypogonadal men nonresponders to the PDE5 inhibitor tadalafil benefit from normalization of testosterone levels with a 1% hydroalcoholic testosterone gel in the treatment of erectile dysfunction (TADTEST study). J Sex Med 2011;8:284-93.
39. 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. J Urol 2004;172:658-63.
40. Spitzer M, Basaria S, Travison TG, et al. Effect of testosterone replacement on response to sildenafil citrate in men with erectile dysfunction: a parallel, randomized trial. Ann Intern Med 2012; 157:681-91.
41. Feldman HA, Goldstein I, Hatzichristou DG, et al. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol 1994;151:54-61.
42. Morley JE. Impotence. Am J Med 1986;80:897-905.
43. Beutel ME, Wiltink J, Hauck EW, et al. Correlations between hormones, physical, and affective parameters in aging urologic outpatients. Eur Urol 2005;47:749-55.
44. Srinivas-Shankar U, Roberts SA, Connolly MJ, 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. J Clin Endocrinol Metab 2010;95:639-50.
45. Camacho EM, Huhtaniemi IT, O'Neill TW, et al. Age-associated changes in hypothalamic-pituitary-testicular function in middleaged and older men are modified by weight change and lifestyle factors: longitudinal results from the European Male Ageing Study. Eur J Endocrinol 2013;168:445-55.
46. Gates MA, Mekary RA, Chiu GR, et al. Sex steroid hormone levels and body composition in men. J Clin Endocrinol Metab 2013;98: 2442-50.
47. Saboor Aftab SA, Kumar S, Barber TM. The role of obesity and type 2 diabetes mellitus in the development of male obesityassociated secondary hypogonadism. Clin Endocrinol (Oxf) 2013; 78:330-7.