Testosterone replacement therapy in male hypogonadism

Journal of Endocrinological Investigation

Volumn 26, Issue 5, 2003, Pages 481-489

  Byrne, M M ^a   Nieschlag, E ^a  

^a UNIVERSITY OF MÜNSTER   (Germany)

Author keywords

Dihydrotestosterone; Hypogonadism; Testosterone; Testosterone gel; Transdermal testosterone

Indexed keywords

ANDROSTANOLONE; EPITESTOSTERONE; FLUOXYMESTERONE; METHYLESTRENOLONE; METHYLTESTOSTERONE; TESTOSTERONE; TESTOSTERONE 4 BUTYLCYCLOHEXANECARBOXYLATE; TESTOSTERONE CIPIONATE; TESTOSTERONE CYCLODEXTRIN; TESTOSTERONE DERIVATIVE; TESTOSTERONE ENANTATE; TESTOSTERONE ESTER; TESTOSTERONE PROPIONATE; TESTOSTERONE UNDECANOATE; UNCLASSIFIED DRUG;

BEHAVIOR DISORDER; BLEEDING; BONE DENSITY; BONE DISEASE; CHOLESTASIS; CIRCADIAN RHYTHM; CLINICAL TRIAL; COGNITION; DIARRHEA; DISEASE EXACERBATION; DOSE TIME EFFECT RELATION; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG COST; DRUG DOSAGE FORM; DRUG HALF LIFE; DRUG IMPLANT; DRUG MONITORING; FLATULENCE; GASTROINTESTINAL SYMPTOM; GYNECOMASTIA; HORMONE SUBSTITUTION; HUMAN; HYPERVISCOSITY SYNDROME; HYPOGONADISM; INFECTION; LEAN BODY WEIGHT; LIVER TOXICITY; LIVER TUMOR; MALE; MUSCLE MASS; NONHUMAN; PELIOSIS HEPATIS; PELLET EXTRUSION; POSITIVE END EXPIRATORY PRESSURE; PROSTATE HYPERTROPHY; PSYCHOSOMATIC DISORDER; REVIEW; SEXUAL BEHAVIOR; SIDE EFFECT; SKIN ALLERGY; SKIN IRRITATION; SLEEP APNEA SYNDROME; STEATORRHEA; TESTOSTERONE BLOOD LEVEL; TOXIC HEPATITIS; TUMOR GROWTH; WEIGHT GAIN;

EID: 0041311217     PISSN: 03914097     EISSN: None     Source Type: Journal    
DOI: 10.1007/BF03345206     Document Type: Review

References (58)

1. Veldhuis J.D., King J.C., Urban R.J., et al. Operating characteristics of the male hypothalamo-pituitary-gonadal axis. Pulsatile release of testosterone and follicle-stimulating hormone and their temporal coupling with luteinizing hormone. J. Clin. Endocrinol. Metab. 1987, 65: 929-941.
2. Jenkins E.P., Hsieh C.L., Milatovich A., et al. Characterizatioin and chromosomal mapping of a human steroid 5α-reductase gene and pseudogene and mapping of the mouse homologue. Genomics 1991, 11: 1102-1112.
3. Thigpen A.E., Silver R.I., Guileyardo J. M., Casey M.L., McConnell J.D., Russell D.W. Tissue distribution and ontogeny of steroid 5α-reductase isoenzyme expression. J. Clin. Invest. 1993, 92: 903-910.
4. Hsiao P.W., Lin D.L., Nakao R., Chang C. The linkage of Kennedy's neuron disease to ARA 24, the first identified androgen receptor polyglutamine region-associated coactivator. J. Biol. Chem. 1999, 29: 20229-20234.
5. Dejager S., Bry-Gauillard H., Bruckert E., et al. A comprehensive endocrine description of Kennedy's disease revealing androgen insensitivity linked to CAG repeat length. J. Clin. Endocrinol. Metab. 2002, 87: 3893-3901.
6. Von Eckardstein S., Syska A., Gromoll J., Kamischke A., Simoni M., Nieschlag E. Inverse correlation between sperm concentration and number of androgen recepor CAG repeats in normal men. J. Clin. Endocrinol. Metab. 2001, 86: 2585-2590.
7. Rajpert-De Meyts E., Leffers H., Petersen J.H., et al. CAG repeat length in androgen-receptor gene and reproductive variables in fertile and infertile men. Lancet 2002, 359: 44-46.
8. Zitzmann M., Brune M., Kornmann B., et al. The CAG repeat polymorphism in the AR gene affects high density lipoprotein cholesterol and arterial vasoreactivity. J. Clin. Endocrinol. Metab. 2001, 86: 4867-73.
9. Zitzmann M., Brune M., Kornmann B., Gromoll J., Junker R., Nieschlag E. The CAG repeat polymorphism in the androgen receptor gene affects bone density and bone metabolism in healthy males. Clin. Endocrinol. (Oxf.) 2001, 55: 649-57.
10. Krithivas K., Yurgalevitch S.M., Mohr B.A., et al. Evidence that the CAG repeat in the androgen receptor gene is associated with the age-related decline in serum androgen levels in men. J. Endocrinol. 1999, 162: 137-142.
11. Hardy D.O., Scher H.I., Bogenreider T., et al. Androgen receptor CAG repeat lengths in prostate cancer: Correlation with age of onset. J. Clin. Endocrinol. Metab. 1996, 81: 4400-4405.
12. Harman S.M., Metler E.J., Tobin J.D., Pearson J., Blackman M.R. Longitudinal effects of aging on serum total and free testosterone levels in healthy men. J. Clin. Endocrinol. Metab. 2001, 88: 724-731.
13. Feldman H.A., Longcope C., Derby C.A., et al. Age trends in the level of serum testosterone and other hormones in middle-aged men: Longitudinal results from the Massachusetts male aging study. J. Clin. Endocrinol. Metab. 2002, 87: 589-98.
14. Nieschlag E., Lammers U., Freischem C.W., Langer K., Wickings E.J. Reproductive functions in young fathers and grandfathers. J. Clin. Endocrinol. Metab. 1982, 55: 676-681.
15. Mulligan T., Iranmanesh A., Veldhuis J.D. Pulsatile iv infusion of recombinant human LH in leuprolide-suppressed men unmasks impoverished Leydig-cell secretory responsiveness to midphysiological LH drive in the aging male. J. Clin. Endocrinol. Metab. 2001, 86: 5547-553.
16. Gray A., Feldman H.A., McKinlay J.B., Longcope C. Age, disease, and changing sex hormone levels in middle-aged men: Results of the Massachusetts male aging study. J. Clin. Endocrinol. Metab. 1991, 73: 1016-1025.
17. Bremner W.J., Prinz P.N. A loss of circadian rhythmicity in blood testosterone levels with aging in normal men. J. Clin. Endocrinol. Metab. 1983, 56: 278-1281.
18. Snyder P.J., Peachey H., Hannoush P., et al. Effect of testosterone treatment on body composition and muscle strength in men over 65 years of age. J. Clin. Endocrinol. Metab. 1999, 84: 2647-2653.
19. Snyder P.J., Peache 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: 1966-1972.
20. Morales A., Lunenfeld B. Investigation, treatment and monitoring of late-onset hypogonadism in males. Official recommendations of ISSAM. Aging Male 2002, 5: 74-86.
21. Davidson J.M., Camargo C.A., Smith E.R. Effects of androgen on sexual behaviour in hypogonadal men. J. Clin. Endocrinol. Metab. 1979, 48: 955-958.
22. Finkelstein J.S. Androgens and bone metabolism. In: Nieschlag E., Behre H.M. (Eds.), Testosterone: Action, Deficiency, Substitution, 2nd ed. Springer-Verlag, Berlin, Heidelberg, 1998, p. 187.
23. Behre H.M., Kliesch S., Leifke E., Link T.M., Nieschlag E. Long-term effect of testosterone therapy on bone mineral density in hypogonadal men. J. Clin. Endocrinol. Metab. 1997, 82: 2386-2390.
24. Bhasin S., Bross R., Storer T.W., Casaburi R. Androgens and muscles. In: Nieschlag E. and Behre H.M. (Eds.), Testosterone: Action, Deficiency, Substitution, 2nd ed. Springer-Verlag, Berlin, Heidelberg, 1998, p. 209.
25. Rolf C., Von Eckardstein S., Koken U., Nieschlag E. Testosterone substitution of hypogonadal men prevents the age-dependent increases in body mass index, body fat and leptin seen in healthy ageing men: Results of a cross-sectional study. Eur. J. Endocrinol. 2002, 146: 505-11.
26. Behre H.M., Nieschlag E. Comparative pharmacokinetics of testosterone esters. In: Nieschlag E. and Behre H.M. (Eds.), Testosterone: Action, Deficiency, Substitution, 2nd ed. Springer-Verlag, Berlin, Heidelberg, 1998, p. 329.
27. Bals-Pratsch M., Knuth U.A., Yoon Y.D., Nieschlag E. Transdermal testosterone substitution therapy for male hypogonadism. Lancet 1986, 2: 943-946.
28. Cunningham G.R., Cordero E., Thornby J.I. Testosterone replacement with transdermal therapeutic systems. J.A.M.A. 1989, 261: 2525-2530.
29. Behre H.M., Von Eckardstein S., Kliesch S., Nieschlag E. Long-term substitution therapy of hypogonadal men with transscrotal testosterone over 7-10 years. Clin. Endocrinol. (Oxf.) 1999, 50: 629-635.
30. Meikle W.A., Arver S., Dobs A.S., Sanders S.W., Rajaram L., Mazer N.A. Pharmacokinetics and metabolism of a permeation enhanced testosterone transdermal system in hypogonadal men: Influence of application site - A clinical research study. J. Clin. Endocrinol. Metab. 1996, 81: 1832-1840.
31. Arver S., Dobs A.S., Meikle A.W., et al. Long-term efficacy and safety of a permeation-enhanced testosterone transdermal system in hypogonadal men. Clin. Endocrinol. (Oxf.) 1997, 47: 727-737.
32. Arver S.A., Dobs A.S., Meikle A.W., Allen R.P., Sanders S.W., Mazer N.A. Improvement of sexual function in testosterone deficient men treated for 1 year with a permeation enhanced testosterone transdermal system. J. Urol. 1996, 155: 1604-1608.
33. Meikle A.W., Arver S., Dobs A.S., et al. Prostate size in hypogonadal men treated with a nonscrotal permeation-enhanced testosterone transdermal system. Urology 1997, 49: 191-196.
34. Swerdloff R.S., Wang C., Cunningham G., et al. Long-term pharmacokinetics of transdermal testosterone gel in hypogonadal men. J. Clin. Endocrinol. Metab. 2000, 85: 4500-4515.
35. Wang C., Swerdloff R.S., 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: 2839-2853.
36. Wang C., Swerdloff R.S., Iranmanesh A., et al. Effects of transdermal testosterone gel on bone turnover markers and bone mineral density in hypogonadal men. Clin. Endocrinol. (Oxf.) 2001, 54: 739-750.
37. Rolf C., Knie U., Lemmnitz G., Nieschlag E. Interpersonal testosterone transfer after topical application of a newly developed testosterone gel preparation. Clin. Endocrinol. (Oxf.) 2002, 56: 637-641.
38. Rolf C., Kemper S., Lemmnitz G., Eickenberg U., Nieschlag E. Pharmacokinetics of a new transdermal testosterone gel in gonadotrophin-suppressed normal men. Eur. J. Endocrinol. 2002, 146: 673-679.
39. Schaison G., Couzinet B. Percutaneous dihydrotestosterone treatment. In: Nieschlag E. and Behre H.M. (Eds.), Testosterone: Action, Deficiency, Substitution, 2nd ed. Springer-Verlag, Berlin, Heidelberg, 1998, p. 423.
40. Wang C., Swerdloff R.S. Should the nonaromatizable androgen dihydrotestosterone be considered as an alternative to testosterone in the treatment of the andropause? J. Clin. Endocrinol. Metab. 2002, 87: 1462-1466.
41. Delanoe D., Fougeyrollas B., Meyer L., Thonneau P. Androgenisation of female partners of men on medroxy-progesterone acetate/percutaneous testosterone contraception. Lancet 1984, 1: 276.
42. Ly LP., Jimenez M., Zhuang T.N., Celermajer D.S., Conway A.J., Handelsman D.J. A double-blind, placebo-controlled, randomized clinical trial of transdermal dihydrotestosterone gel on muscular strength, mobility, and quality of life in older men with partial androgen deficiency. J. Clin. Endocrinol. Metab. 2001, 86: 4078-4088.
43. Handelsman D.J. Clinical pharmacology of testosterone pellet implants. In: Nieschlag E. and Behre H.M. (Eds.), Testosterone: Action, Deficiency, Substitution, ed. 2. Springer-Verlag, Berlin, Heidelberg, 1998, p. 349.
44. Behre H.M., Nieschlag E. Testosterone buciclate (20 Aet-1) in hypogonadal men: Pharmacokinetics and pharmacodynamics of the new long-acting androgen ester. J. Clin. Endocrinol. Metab. 1992, 75: 1204-1210.
45. Von Eckardstein S., Nieschlag E. Treatment of male hypogonadism with testosterone undecanoate injected at extended intervals of 12 weeks: A phase II study. J. Androl. 2002, 23: 419-425.
46. Kamischke A., Heuermann T., Krüger K., et al. An effective hormonal male contraceptive using testosterone undecanoate with oral or injectable norethisterone preparations. J. Clin. Endocrinol. Metab. 2002, 87: 530-539.
47. Cummings D.E., Kumar N., Bardin D.W., Sundaram K., Bremmner W.J. Prostate-sparing effects in primates of the potent androgen 7α-methyl-19-nortestosterone: A potential alternative to testosterone for androgen replacement and male contraception. J. Clin. Endocrinol. Metab. 1998, 83: 4212-4219.
48. Anderson R.A., Martin C.W., Kung A.W., et al. 7α-methyl-19-nortestosterone maintains sexual behavior and mood in hypogonadal men. J. Clin. Endocrinol. Metab. 1999, 84: 3556-3562.
49. Salehian B., Wang C., Alexander G., et al. Pharmacokinetics, bioefficacy, and safety of sublingual testosterone cyclodextrin in hypogonadal men: Comparison to testosterone enanthate - A clinical research center study. J. Clin. Endocrinol. Metab. 1995, 80: 3567-3575.
50. Wang C., Eyre D.R., Clark R., et al. Sublingual testosterone replacement improves muscle mass and strength, decreases bone resorption, and increases bone formation markers in hypogonadal men - A clinical research center study. J. Clin. Endocrinol. Metab. 1996, 81: 3654-3662.
51. Dobs A.S., Hoover D.R., Chen M.C., Allen R. Pharmacokinetic characteristics, efficacy, and safety of buccal testosterone in hypogonadal males: A pilot study. J. Clin. Endocrinol. Metab. 1998, 83: 33-39.
52. Morales A., Johnston B., Heaton J.P., Lundie M. Testosterone supplementation for hypogonadal impotence assessment of biochemical measures and therapeutic outcomes. J. Urol. 1997, 157: 849-854.
53. Hajjar R.R., Kaiser F.E., Morley J.E. Outcomes of long-term testosterone replacement in older hypogonadal males: A retrospective analysis. J. Clin. Endocrinol. Metab. 1997, 82: 3793-3796.
54. Sandblom R.E., Matsumoto A.M., Schoene R.B., Lee K.A., Giblin E.C., Bremner W.J., Pierson D.J. Obstructive sleep apnea induced by testosterone administration. N. Engl. J. Med. 1983, 308: 508-510.
55. Luboshitzky R., Aviv A., Hefetz A., et al. Decreased pituitary-gonadal secretion in men with obstructive sleep apnea. J. Clin. Endocrinol. Metab. 2002, 87: 3394-3398.
56. Behre H.M., Bohmeyer J., Nieschlag E. Prostate volume in testosterone-treated and untreated hypogonadal men in comparison to age-matched normal controls. Clin. Endocrinol. (Oxf.) 1994, 40: 341-349.
57. Negro-Vilar A. Selective androgen receptor modulators (SARMs): A novel approach to androgen therapy for the new millennium. J. Clin. Endocrinol. Metab. 1999, 84: 3459-3462.
58. Nieschlag E., Behre H.M. (Eds.), Andrology: Male Reproductive Health and Dysfunction, 1st ed. Springer-Verlag, Heidelberg, New York, 1997, p. 81.