Testosterone restoration using enclomiphene citrate in men with secondary hypogonadism: A pharmacodynamic and pharmacokinetic study

BJU International

Volumn 112, Issue 8, 2013, Pages 1188-1200

  Wiehle, Ronald ^a   Cunningham, Glenn R ^b   Pitteloud, Nelly ^b   Wike, Jenny ^a   Hsu, Kuang ^a   Fontenot, Gregory K ^a   Rosner, Michele ^a   Dwyer, Andrew ^b   Podolski, Joseph ^a  

^a Department of Urology Repros Therapeutics Inc   (United States)

^b LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

Author keywords

LH; secondary hypogonadism; serum testosterone; testosterone restoration; transdermal testosterone

Indexed keywords

ENCLOMIFENE CITRATE; FOLLITROPIN; HYDROCORTISONE; LIPID; LUTEINIZING HORMONE; SOMATOMEDIN C; TESTOSTERONE; THYROTROPIN;

ADULT; AGED; ARTICLE; BLOOD SAMPLING; CLINICAL ARTICLE; CONTROLLED STUDY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG EFFECT; HORMONAL THERAPY; HUMAN; HYPOGONADISM; LUTEINIZING HORMONE BLOOD LEVEL; MALE; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; SPERMATOZOON COUNT; TESTOSTERONE BLOOD LEVEL;

EID: 84887284539     PISSN: 14644096     EISSN: 1464410X     Source Type: Journal    
DOI: 10.1111/bju.12363     Document Type: Article

References (26)

1. Hill S, Arutchelvam AV, Quinton R,. Enclomiphene, an estrogen receptor antagonist for the treatment of testosterone deficiency in men. IDrugs 2009; 12: 109-119
2. Whitten SJ, Nangia AK, Kolettis PN,. Select patients with hypogonadal hypogonadism may respond to treatment with clomiphene citrate. Fertil Steril 2006; 86: 1664-1668
3. Kaminetsky J, Hemani ML,. Clomiphene citrate and enclomiphene for treatment of hypogonadal androgen deficiency. Expert Opin Investig Drugs 2009; 18: 1-9
4. Pitteloud N, Mootha VK, Dwyer AA, et al. Relationship between testosterone levels, insulin sensitivity, and mitochondrial function in men. Diabetes Care 2005; 28: 1636-1642
5. Pitteloud N, Hardin M, Dwyer AA, et al. Increasing insulin resistance is associated with a decrease in Leydig cell testosterone secretion in men. J Clin Endocrinol Metab 2005; 90: 2636-2641
6. Lunenfeld B,. Testosterone deficiency and the metabolic syndrome. Ageing Male 2007; 10: 53-56
7. Kalyani RR, Dobbs AS,. Androgen deficiency, diabetes, and the metabolic syndrome. Curr Opin Endocrinol Diabetes Obes 2007; 14: 226-234
8. Guay AT, Jacobson J,. The relationship between testosterone levels, the metabolic syndrome (by two criteria), and insulin resistance in a population of men with organic erectile dysfunction. J Sex Med 2007; 4 (4 Pt 1): 1046-1055
9. Laughlin GA, Barrett-Connor E, Bergstrom J,. Low serum testosterone and mortality in older men. J Clin Endocrinol Metab 2008; 93: 68-73
10. Haffner SM, Karhapaa P, Mykkanen L, Lasakso M,. Insulin resistence, body fat distribution, and sex hormones in men. Diabetes 1994; 43: 212-219
11. Tajar A, Forti G, O'Neill TW, et al. Characterisitcs of secondary, primary, and compensated hypogonadism in ageing men; evidence from the European Male Ageing Study. J Clin Endocrinol Metab 2010; 95: 1810-1818
12. Hoffman AR, Crowley WF Jr,. Induction of puberty in men by long-term pulsatile administration of low-dose gonadotropin-releasing hormone. N Engl J Med 1982; 307: 1237-1241
13. Pitteloud N, Dwyer AA, DeCruz S, et al. Ihibition of luteinizing hormone secretion by testosterone in men requires aromatization for its pituitary but not its hypothalamic effects: evidence from the tandem study of normal and gonadotropin-releasing hormone-deficient men. J Clin Endocrinol Metab 2008; 93: 784-791
14. Pitteloud N, Dwyer AA, DeCruz S, et al. The relative role of gonadal sex steroids and gonadotropin-releasing hormone pulse frequency in the regulation of follicle-stimulating hormone secretion in men. J Clin Endocrinol Metab 2008; 93: 2686-2692
15. Sykiotis GP, Hoang XH, Avbell M, et al. Congenital idiopathic hypogonadotropic hypogonadism: evidence of defects in the hypothalamus, pituitary, and testes. J Clin Endocrinol Metab 2010; 95: 3019-3027
16. Gan EH, Quinton R,. Physiological significance of the rhythmic secretion of hypothalamic and pituitary hormones. Prog Brain Res 2010; 181: 111-126
17. Bremner WJ, Vitiello MV, Prinz PN,. Loss of circadian rhythmicity in blood testosterone levels with aging in normal men. J Clin Endocrinol Metab 1983; 56: 1278-1281
18. Keenan DM, Veldhuis JD,. Age-dependent regression analysis of male gonadal axis. Am J Physiol Integr Comp Physiol 2009; 297: R1215-1227
19. Caronia LM, Dwyer AA, Hayden D, Amati F, Pitteloud N, Hayes FJ,. Abrupt decrease in serum testosterone levels after an oral glucose load in men: implications for screening for hypogonadism. Clin Endocrinol (Oxf) 2013; 78: 291-296
20. Hayes FJ, Seminara SB, DeCruz S, Boepple PA, Crowley WF Jr,. Aromatase inhibition in the human male reveals a hypothalamic site of estrogen feedback. J Clin Endocrinol Metab 2000; 85: 3027-3035
21. van As A, Wiehle RD,. Enclomiphene citrate (Androxal™) decreases serum glucose in men with idiopathic hypogonadotrophic hypogonadism. The 90th Annual meeting of the Endocrine Society, June 17, 2008, San Francisco, CA
22. Anonymous. AndroGel 1% (testosterone gel) package insert from Unimed Pharmaceuticals, Inc., 2000. Deerfield IL, d 9/2000
23. Kaminetsky J, Werner M, Fontenot G, Wiehle RD,. Oral enclomiphene citrate stimulates the endogenous production of testosterone and sperm counts in men with low testosterone: comparison with testosterone gel. J Sex Med 2013; 10: 1628-1635
24. Tenover JS, Dahl KD, Hsieh AJ, Lim P, Matsumoto AM, Bremner WJ,. Serum bioactive and immunoreactive follicle-stimulating hormone levels and the response to clomiphene citrate in healthy young and elderly men. J Clin Endocrinol Metab 1987; 634: 1103-1108
25. Luboshitzky R, Shen-Orr X, Herer P,. Middle-aged men secrete less testosterone at night than young healthy men. J Clin Endocrinol Metab 2003; 88: 3160-3166
26. Mikkelson TJ, Kroboth PD, Cameron WJ, Dittert LW, Manberg PJ,. Single dose pharamacokinetics of clomiphene citrate in normal volunteers. Fertil Steril 1986; 46: 392-396