A placebo-controlled, randomized clinical trial using testosterone undecanoate with injectable norethisterone enanthate: Effect on anthropometric, metabolic and biochemical parameters

International Journal of Andrology

Volumn 34, Issue 6 PART 1, 2011, Pages 548-555

  Pelusi, C ^a,b   Costantino, A ^b   Cerpolini, S ^b   Pelusi, G ^b   Meriggiola, M C ^b   Pasquali, R ^a  

^a Division of Endocrinology ^*  (Italy)

^b UNIVERSITY OF BOLOGNA   (Italy)

Author keywords

Androgens; Contraception; Testosterone

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; CHOLESTEROL; CREATININE; GLUCOSE; HEMOGLOBIN; HIGH DENSITY LIPOPROTEIN; INSULIN; NORETHISTERONE ENANTATE; TESTOSTERONE UNDECANOATE; TRIACYLGLYCEROL; UREA;

ADULT; ANTHROPOMETRIC PARAMETERS; ARM CIRCUMFERENCE; ARTICLE; BIOCHEMISTRY; BLOOD CELL COUNT; BODY MASS; CHOLESTEROL BLOOD LEVEL; CONTRACEPTION; CONTROLLED STUDY; GLUCOSE BLOOD LEVEL; HEMATOCRIT; HUMAN; INSULIN SENSITIVITY; KIDNEY FUNCTION; LEAN BODY WEIGHT; LIVER FUNCTION; MALE; METABOLIC PARAMETERS; NORMAL HUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SKINFOLD; THROMBOCYTE COUNT; WAIST CIRCUMFERENCE;

ADULT; ANTHROPOMETRY; BODY MASS INDEX; HUMANS; MALE; NORETHINDRONE; PLACEBOS; TESTOSTERONE;

EID: 81455158813     PISSN: 01056263     EISSN: 13652605     Source Type: Journal    
DOI: 10.1111/j.1365-2605.2010.01122.x     Document Type: Article

References (40)

1. Anawalt BD, Herbst KL, Matsumoto AM, Mulders TM, Coelingh-Bennink HJ & Bremner WJ. (2000) Desogestrel plus testosterone effectively suppresses spermatogenesis but also causes modest weight gain and high-density lipoprotein suppression. Fertil Steril 74, 707-714.
2. Baecke JA, Burema J & Frijters JE. (1982) A short questionnaire for the measurement of habitual physical activity in epidemiological studies. Am J Clin Nutr 36, 936-942.
3. Bagatell CJ, Heiman JR, Matsumoto AM, Rivier JE & Bremner WJ. (1994) Metabolic and behavioral effects of high-dose, exogenous testosterone in healthy men. J Clin Endocrinol Metab 79, 561-567.
4. Bhasin S, Storer TW, Berman N, Callegari C, Clevenger B, Phillips J, Bunnell TJ, Tricker R, Shirazi A & Casaburi R. (1996) The effects of supraphysiologic doses of testosterone on muscle size and strength in normal men. N Engl J Med 335, 1-7.
5. Bhasin S, Woodhouse L, Casaburi R, Singh AB, Bhasin D, Berman N et al. (2001) Testosterone dose-response relationships in healthy young men. Am J Physiol Endocrinol Metab 28, E1172-E1181.
6. Bhasin S, Taylor WE, Singh R, Artaza J, Sinha-Hikim I, Jasuja R, Choi H & Gonzalez-Cadavid NF. (2003) The mechanisms of androgen effects on body composition: mesenchymal pluripotent cell as the target of androgen action. J Gerontol A Biol Sci Med Sci 58, M1103-M1110.
7. Bhasin S, Calof OM, Storer TW, Lee ML, Mazer NA, Jasuja R, Montori VM, Gao W & Dalton JT. (2006a) Drug insight: testosterone and selective androgen receptor modulators as anabolic therapies for chronic illness and aging. Nat Clin Pract Endocrinol Metab 2, 146-159.
8. Bhasin S, Cunningham GR, Hayes FJ, Matsumoto AM, Snyder PJ, Swerdloff RS & Montori VM. (2006b) Testosterone therapy in adult men with androgen deficiency syndromes: an endocrine society clinical practice guideline. J Clin Endocrinol Metab 91, 1995-2010.
9. Brady BM, Walton M, Hollow N, Kicman AT, Baird DT & Anderson RA. (2004) Depot testosterone with etonogestrel implants result in induction of azoospermia in all men for long-term contraception. Hum Reprod 19, 2658-2667.
10. Brown BH, Karatzas T, Nakielny R & Clarke RG. (1988) Determination of upper arm muscle and fat areas using electrical impedance measurements. Clin Phys Physiol Meas 9, 47-55.
11. Cohen JC & Hickman R. (1987) Insulin resistance and diminished glucose tolerance in powerlifters ingesting anabolic steroids. J Clin Endocrinol Metab 64, 960-963.
12. Corbould A. (2007) Chronic testosterone treatment induces selective insulin resistance in subcutaneous adipocytes of women. J Endocrinol 192, 585-594.
13. von Eckardstein A, Kliesch S, Nieschlag E, Chirazi A, Assmann G & Behre HM. (1997) Suppression of endogenous testosterone in young men increases serum levels of high density lipoprotein subclass lipoprotein A-I and lipoprotein(a). J Clin Endocrinol Metab 82, 3367-3372.
14. Forbes GB. (1985) The effect of anabolic steroids on lean body mass: the dose response curve. Metabolism 34, 571-573.
15. Frisancho AR. (1981) New norms of upper limb fat and muscle areas for assessment of nutritional status. Am J Clin Nutr 34, 2540-2545.
16. Giannitrapani L, Soresi M, La Spada E, Cervello M, D'Alessandro N & Montalto G. (2006) Sex hormones and risk of liver tumor. Ann N Y Acad Sci 1089, 228-236.
17. Haffner SM, Karhapaa P, Mykkanen L & Laakso M. (1994) Insulin resistance, body fat distribution, and sex hormones in men. Diabetes 43, 212-219.
18. Holmang A & Bjorntorp P. (1992) The effects of testosterone on insulin sensitivity in male rats. Acta Physiol Scand 146, 505-510.
19. Kamischke A, Venherm S, Ploger D, von Eckardstein S & Nieschlag E. (2001) Intramuscular testosterone undecanoate and norethisterone enanthate in a clinical trial for male contraception. J Clin Endocrinol Metab 86, 303-309.
20. Langer C, Gansz B, Goepfert C, Engel T, Uehara Y, von Dehn G, Jansen H, Assmann G & von Eckardstein A. (2002) Testosterone up-regulates scavenger receptor BI and stimulates cholesterol efflux from macrophages. Biochem Biophys Res Commun 296, 1051-1057.
21. Lohman TG, Roche AF & Matorell R. (1988) Anthropometric Standardization Reference Manual. Human Kinetics Books, Champaign, IL.
22. Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF & Turner RC. (1985) Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia 28, 412-419.
23. Meriggiola MC, Marcovina S, Paulsen CA & Bremner WJ. (1995) Testosterone enanthate at a dose of 200mg/week decreases HDL-cholesterol levels in healthy men. Int J Androl 18, 237-242.
24. Meriggiola MC, Costantino A, Saad F, D'Emidio L, Morselli Labate AM, Bertaccini A et al. (2005) Norethisterone enanthate plus testosterone undecanoate for male contraception: effects of various injection intervals on spermatogenesis, reproductive hormones, testis, and prostate. J Clin Endocrinol Metab 90, 2005-2014.
25. Nieschlag E, Zitzmann M & Kamischke A. (2003) Use of progestins in male contraception. Steroids 68, 965-972.
26. Nisenblat V & Norman RJ. (2009) Androgens and polycystic ovary syndrome. Curr Opin Endocrinol Diabetes Obes 16, 224-231.
27. Page ST, Amory JK & Bremner WJ. (2008) Advances in male contraception. Endocr Rev 29, 465-493.
28. Partsch CJ, Weinbauer GF, Fang R & Nieschlag E. (1995) Injectable testosterone undecanoate has more favourable pharmacokinetics and pharmacodynamics than testosterone enanthate. Eur J Endocrinol 132, 514-519.
29. Pitteloud N, Mootha VK, Dwyer AA, Hardin M, Lee H, Eriksson KF et al. (2005) Relationship between testosterone levels, insulin sensitivity, and mitochondrial function in men. Diabetes Care 28, 1636-1642.
30. Qoubaitary A, Meriggiola C, Ng CM, Lumbreras L, Cerpolini S, Pelusi G, Christensen PD, Hull L, Swerdloff RS & Wang C. (2006) Pharmacokinetics of testosterone undecanoate injected alone or in combination with norethisterone enanthate in healthy men. J Androl 27, 853-867.
31. Saad F & Gooren L. (2009) The role of testosterone in the metabolic syndrome: a review. J Steroid Biochem 114, 40-43.
32. Saad F, Kamischke A, Yassin A, Zitzmann M, Schubert M, Jockenhel F, Behre HM, Gooren L & Nieschlag E. (2007) More than eight years' hands-on experience with the novel long-acting parenteral testosterone undecanoate. Asian J Androl 9, 291-297.
33. Singh AB, Hsia S, Alaupovic P, Sinha-Hikim I, Woodhouse L, Buchanan TA, Shen R, Bross R, Berman N & Bhasin S. (2002) The effects of varying doses of T on insulin sensitivity, plasma lipids, apolipoproteins, and C-reactive protein in healthy young men. J Clin Endocrinol Metab 87, 136-143.
34. Singh R, Artaza JN, Taylor WE, Braga M, Yuan X, Gonzalez-Cadavid NF & Bhasin S. (2006) Testosterone inhibits adipogenic differentiation in 3T3-L1 cells: nuclear translocation of androgen receptor complex with beta-catenin and T-cell factor 4 may bypass canonical Wnt signaling to down-regulate adipogenic transcription factors. Endocrinology 147, 141-154.
35. Storer TW, Magliano L, Woodhouse L, Lee ML, Dzekov C, Dzekov J, Casaburi R & Bhasin S. (2003) Testosterone dose-dependently increases maximal voluntary strength and leg power, but does not affect fatigability or specific tension. J Clin Endocrinol Metab 88, 1478-1485.
36. WHO (1996) Contraceptive efficacy of testosterone-induced azoospermia and oligospermia in normal men. Fertil Steril 65, 821-829.
37. Wu FC & von Eckardstein A. (2003) Androgens and coronary artery disease. Endocr Rev 24, 183-217.
38. Young NR, Baker HW, Liu G & Seeman E. (1993) Body composition and muscle strength in healthy men receiving testosterone enanthate for contraception. J Clin Endocrinol Metab 77, 1028-1032.
39. Zitzmann M, Junker R, Kamischke A & Nieschlag E. (2002) Contraceptive steroids influence the hemostatic activation state in healthy men. J Androl 23, 503-511.
40. Zitzmann M, Erren M, Kamischke A, Simoni M & Nieschlag E. (2005) Endogenous progesterone and the exogenous progestin norethisterone enanthate are associated with a proinflammatory profile in healthy men. J Clin Endocrinol Metab 90, 6603-6608.