Enclomiphene citrate for the treatment of secondary male hypogonadism

References

• 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(6):2536–2559.
   PubMed Web of Science ®Google Scholar
• Pastuszak AW, Gomez LP, Scovell JM, et al. Comparison of the effects of testosterone gels, injections, and pellets on serum hormones, erythrocytosis, lipids, and prostate-specific antigen. Sex Med. 2015;3(3):165–173.
   PubMed Web of Science ®Google Scholar
• Rastrelli G, Corona G, Tarocchi M, et al. How to define hypogonadism? Results from a population of men consulting for sexual dysfunction. J Endocrinol Invest. 2016;39(4):473–484.
   PubMed Web of Science ®Google Scholar
• 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(7):762–769.
   PubMed Web of Science ®Google Scholar
• Corona G, Rastrelli G, Vignozzi L, et al. How to recognize late-onset hypogonadism in men with sexual dysfunction. Asian J Androl. 2012;14(2):251–259.
   PubMed Web of Science ®Google Scholar
• Araujo AB, Esche GR, Kupelian V, et al. Prevalence of symptomatic androgen deficiency in men. J Clin Endocrinol Metab. 2007;92(11):4241–4247.
   PubMed Web of Science ®Google Scholar
• Wu F.C, Tajar A, Beynon JM, et al. Identification of late-onset hypogonadism in middle-aged and elderly men. N Engl J Med. 2010;363(2):123–135.
   PubMed Web of Science ®Google Scholar
• Surampudi PN, Wang C, Swerdloff R. Hypogonadism in the aging male diagnosis, potential benefits, and risks of testosterone replacement therapy. Int J Endocrinol. 2012;2012:1–20.
   Web of Science ®Google Scholar
• Wang C, Jackson G, Jones TH, et al. Low testosterone associated with obesity and the metabolic syndrome contributes to sexual dysfunction and cardiovascular disease risk in men with type 2 diabetes. Diabetes Care. 2011;34(7):1669–1675.
   PubMed Web of Science ®Google Scholar
• Corona G, Isidori AM, Aversa A, et al. Endocrinologic control of men’s sexual desire and arousal/erection. J Sex Med. 2016;13(3):317–337.
   PubMed Web of Science ®Google Scholar
• McBride JA, Carson CC, Coward RM. Diagnosis and management of testosterone deficiency. Asian J Androl. 2015;17(2):177–186.
   PubMed Web of Science ®Google Scholar
• Corona G, Giagulli VA, Maseroli E, et al. Therapy of endocrine disease: testosterone supplementation and body composition: results from a meta-analysis study. Eur J Endocrinol. 2016;174(3):R99–R116.
   PubMed Web of Science ®Google Scholar
• Sanford EJ, Paulson DF, Rohner TJ, et al. The effects of castration on adrenal testosterone secretion in men with prostatic carcinoma. J Urol. 1977;118(6):1019–1021.
   PubMed Web of Science ®Google Scholar
• Longcope C, Kato T, Horton R. Conversion of blood androgens to estrogens in normal adult men and women. J Clin Invest. 1969;48(12):2191–2201.
   PubMed Web of Science ®Google Scholar
• Finkelstein JS, Lee H, Burnett-Bowie S-AM, et al. Gonadal steroids and body composition, strength, and sexual function in men. N Engl J Med. 2013;369(11):1011–1022.
   PubMed Web of Science ®Google Scholar
• Falahati-Nini A, Riggs BL, Atkinson EJ, et al. Relative contributions of testosterone and estrogen in regulating bone resorption and formation in normal elderly men. J Clin Invest. 2000;106(12):1553–1560.
   PubMed Web of Science ®Google Scholar
• Leder BZ, LeBlanc KM, Schoenfeld DA, et al. Differential effects of androgens and estrogens on bone turnover in normal men. J Clin Endocrinol Metab. 2003;88(1):204–210.
   PubMed Web of Science ®Google Scholar
• Handelsman DJ. Global trends in testosterone prescribing, 2000–2011: expanding the spectrum of prescription drug misuse. Med J Aust. 2013;199(8):548–551.
   PubMed Web of Science ®Google Scholar
• Spitzer M, Huang G, Basaria S, et al. Risks and benefits of testosterone therapy in older men. Nat Rev Endocrinol. 2013;9(7):414–424.
   PubMed Web of Science ®Google Scholar
• U.S. Food and Drug Administration. FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use. [ cited 2015 Jun]. Available from: Drugs/DrugSafety/ucm436259.htm.
   Google Scholar
• Agency, EM. PRAC review does not confirm increase in heart problems with testosterone medicines, in Committee recommends medicines can continue to be given for their authorised uses. London: European Medicines Agency; 2014. p. 1–2.
   Google Scholar
• Coss CC, Jones A, Hancock ML, et al. Selective androgen receptor modulators for the treatment of late onset male hypogonadism. Asian J Androl. 2014;16(2):256–261.
   PubMed Web of Science ®Google Scholar
• Crosnoe-Shipley LE, Elkelany OO, Rahnema CD, et al. Treatment of hypogonadotropic male hypogonadism: case-based scenarios. World J Nephrol. 2015;4(2):245–253.
   PubMedGoogle Scholar
• de Ronde W, de Jong FH. Aromatase inhibitors in men: effects and therapeutic options. Reprod Biol Endocrinol. 2011;9:93.
   PubMed Web of Science ®Google Scholar
• T’Sjoen GG, Giagulli VA, Delva H, et al. Comparative assessment in young and elderly men of the gonadotropin response to aromatase inhibition. J Clin Endocrinol Metab. 2005;90(10):5717–5722.
   PubMed Web of Science ®Google Scholar
• Surampudi P, Swerdloff RS, Wang C. An update on male hypogonadism therapy. Expert Opin Pharmacother. 2014;15(9):1247–1264.
   PubMed Web of Science ®Google Scholar
• Fejes I, Koloszár S, Závaczki Z, et al. Effect of body weight on testosterone/estradiol ratio in oligozoospermic patients. Arch Androl. 2006;52(2):97–102.
   PubMed Web of Science ®Google Scholar
• Camacho EM, Huhtaniemi IT, O’Neill TW, et al. Age-associated changes in hypothalamic-pituitary-testicular function in middle-aged and older men are modified by weight change and lifestyle factors: longitudinal results from the European Male Ageing Study. Eur J Endocrinol. 2013;168(3):445–455.
   PubMed Web of Science ®Google Scholar
• Tsourdi E, Kourtis A, Farmakiotis D, et al. The effect of selective estrogen receptor modulator administration on the hypothalamic-pituitary-testicular axis in men with idiopathic oligozoospermia. Fertil Steril. 2009;91(4 Suppl):1427–1430.
   PubMed Web of Science ®Google Scholar
• Wang C, Nieschlag E, Swerdloff R, et al. Investigation, treatment and monitoring of late-onset hypogonadism in males: ISA, ISSAM, EAU, EAA and ASA recommendations. Eur J Endocrinol. 2008;159(5):507–514.
   PubMed Web of Science ®Google Scholar
• Wiehle R, Cunningham GR, Pitteloud N, et al. Testosterone restoration using enclomiphene citrate in men with secondary hypogonadism: a pharmacodynamic and pharmacokinetic study. BJU Int. 2013;112(8):1188–1200.
   PubMed Web of Science ®Google Scholar
• Hill S, Arutchelvam V, Quinton R. Enclomiphene, an estrogen receptor antagonist for the treatment of testosterone deficiency in men. IDrugs. 2009;12(2):109–119.
   PubMedGoogle Scholar
• Huang ES, Miller WL. Estrogenic and antiestrogenic effects of enclomiphene and zuclomiphene on gonadotropin secretion by ovine pituitary cells in culture. Endocrinology. 1983;112(2):442–448.
   PubMed Web of Science ®Google Scholar
• Wiehle RD, Fontenot GK, Wike J, et al. Enclomiphene citrate stimulates testosterone production while preventing oligospermia: a randomized phase II clinical trial comparing topical testosterone. Fertil Steril. 2014;102(3):720–727.
   PubMed Web of Science ®Google Scholar
• Gupta P, Kriplani A. Enclomiphene citrate versus clomiphene citrate for ovulation induction in women with unexplained infertility. Fertility and Sterility. 2013;100(3):S143.
   Web of Science ®Google Scholar
• Enclomiphene – MeSH – NCBI. Bethesda (MD): National Library of Medicine; 2014.
   Google Scholar
• CLOMID® (clomiphene citrate tablets USP) [Internet]. [cited 2012]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016131s026lbl.pdf
   Google Scholar
• Dutertre M, Smith CL. Molecular mechanisms of selective estrogen receptor modulator (SERM) action. J Pharmacol Exp Ther. 2000;295(2):431–437.
   PubMed Web of Science ®Google Scholar
• Cummins CH. Stereospecific syntheses of clomiphene and tamoxifen via stannylcupration of diphenylacetylene. Synth Commun. 1995;25(24):4071–4079.
   Web of Science ®Google Scholar
• Wiehle RD, Fontenot GK, Willett MS, et al. Enclomiphene citrate stimulates serum testosterone in men with low testosterone within 14 days. J Mens Health. 2014;11(4):196–205.
   Web of Science ®Google Scholar
• Podolski J, Wiehle R, Trans-clomiphene for the treatment of benign prostate hypertrophy, prostate cancer, hypogonadism, elevated triglycerides and high cholesterol. Google Patents. 2006.
   Google Scholar
• Wiehle R, Rice K, Garcia W, et al. Oral enclomiphene raises total serum testosterone in baboons and hypogonadal men [abstract no. P1212]. Intl Soc Endocrinol. 2004;369:12.
   Google Scholar
• Kaminetsky J, Werner M, Fontenot G, et al. 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(6):1628–1635.
   PubMed Web of Science ®Google Scholar
• Kim ED, McCullough A, Kaminetsky J. Oral enclomiphene citrate raises testosterone and preserves sperm counts in obese hypogonadal men, unlike topical testosterone: restoration instead of replacement. BJU Int. 2016;117(4):677–685.
   PubMed Web of Science ®Google Scholar
• Lim VS, Fang VS. Restoration of plasma testosterone levels in uremic men with clomiphene citrate. J Clin Endocrinol Metabolism. 1976;43(6):1370–1377.
   PubMed Web of Science ®Google Scholar
• Ramasamy R, Scovell JM, Kovac JR, et al. Testosterone supplementation versus clomiphene citrate for hypogonadism: an age matched comparison of satisfaction and efficacy. J Urol. 2014;192(3):875–879.
   PubMed Web of Science ®Google Scholar
• Kaminetsky J, Hemani ML. Clomiphene citrate and enclomiphene for the treatment of hypogonadal androgen deficiency. Expert Opin Investig Drugs. 2009;18(12):1947–1955.
   PubMed Web of Science ®Google Scholar
• Shabsigh A, Kang Y, Shabsign R, et al. Clomiphene citrate effects on testosterone/estrogen ratio in male hypogonadism. J Sex Med. 2005;2(5):716–721.
   PubMed Web of Science ®Google Scholar
• Repros therapeutics announces cancellation of FDA Advisory Committee Meeting to review enclomiphene for the treatment of secondary hypogonadism [Internet]. [cited 2015]. Available from: http://www.drugs.com/nda/androxal_151029.html
   Google Scholar
• Aversa A, Bruzziches R, Francomano D, et al. Effects of testosterone undecanoate on cardiovascular risk factors and atherosclerosis in middle‐aged men with late‐onset hypogonadism and metabolic syndrome: results from a 24‐month, randomized, double‐blind, placebo‐controlled study. J Sex Med. 2010;7(10):3495–3503.
   PubMed Web of Science ®Google Scholar