Summary
Lansoprazole is a new proton-pump inhibitor that has been proven safe and effective in the treatment of gastroesophageal reflux disease (GERD) and peptic ulcer disease. In rats, the drug inhibited testosterone synthesis and was associated with Leydig cell tumours. To determine the effect of a high therapeutic dose of lansoprazole (60mg day) on male hormone levels and gonadal function, a randomised double-blind parallel study was conducted. 32 healthy volunteers participated for 8 weeks. Endocrine profiles included serum testosterone, luteinising hormone (LH), follicle-stimulating hormone (FSH), sex hormone-binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEA-S), prolactin, estradiol, cortisol and thyroid function. As further evaluation of an effect on hormones, testes were monitored for changes in size and breasts for gynaecomastia. Sexual function parameters were assessed by semen analyses and a sexual function questionnaire. Testosterone levels tended to increase slightly in the lansoprazole group and decrease slightly in the placebo group. While the difference between groups was statistically significant, the magnitude of changes was small and not clinically significant. Overall, there were no clinically significant changes in hormone levels. All testicular and breast measurements remained within normal range. Similarly, no clinically significant differences between treatment groups occurred in either semen analysis or sexual-function parameters.
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Nagaya H, Satoh H, Kubo K, et al. Possible mechanism for the inhibition of gastric (H+ + K+ -adenosine triphosphatase by the proton pump inhibitor AG-1749. J Pharmacol Exp Ther 1989; 248(2): 799–805
Tamura K, Yamamoto A, Shinoyama N, et al. Clinical effect of AG-1749 on gastric ulcer: histological change of gastric mucosa and effect on Helicobacter pylori. Yakuri to Chiryo 1990; 18: 4877–90
Jhala NC, McFarland M, Brightman S, et al. Effect of short term treatment with lansoprazole on H. Pylori and antral gastritis in patients with duodenal ulcers [abstract 675]. American Gastroenterological Association; May 9-14: San Francisco, 1992
Bardhan KD, Long R, Bawkey CJ, et al. Lansoprazole, a new proton-pump inhibitor, vs ranitidine in the treatment of reflux erosive esophagitis [abstract]. Gastroenterology 1991; 100: A30
Benhaim MC, Evreux M, Salducci J, et al. Lansoprazole and ranitidine in treatment of reflux oesophagitis: double blind comparative trial [abstract]. Gastroenterology 1990; 98: A20
Robinson M, Kogut D, Jennings D, et al. Lansoprazole heals erosive reflux esophagitis better than ranitidine [abstract 2178]. American Gastroenterological Association; May 9-14: San Francisco, 1992
Robinson MG, Campbell DR, Sonata S, et al. Lansoprazole heals H2 resistant erosive reflux esophagitis [abstract]. Gastroenterology 1990; 98: A113
Wormsley KG, Bardhan KD, Morgan AG, et al. Lansoprazole (LAN) is more effective than ranitidine (RAN) in the healing of gastric ulcer [abstract T190]. Gut 1992; 33(1): 548
Londong W, Hotz J, Kleinert R, et al. Dose finding study in gastric ulcer with lansoprazole, a new proton pump inhibitor [abstract PP 670]. The World Congresses of Gastroenterology; August 26-31: Sydney, Australia, 1990
Takemoto T, Namiki M, Goto Y, et al. A study of clinical usefulness of lansoprazole (AG-1749) in treating gastric ulcer: a comparison with famotidine by multi clinic, double-blind technique. Rinshoseijinbyo 1991; 21(2): 327–45
Florent C, Forestier S, Joubert-Coullin M. Lansoprazole versus omeprazole: efficacy and safety in acute gastric ulcer [abstract]. European Gastroenterology Week; September 25-30: Athens, 1992
Hawkey CJ, Bardhan KD, Long RG, et al. Improved symptom relief and duodenal ulcer healing with lansoprazole compared to ranitidine [abstract]. Gastroenterology 1991; 100: A80
Licht H, Andrieu J, Bognel JC, et al. Lansoprazole versus ranitidine dans le traitement des ulcers duodenaux: resultats d’un essai multicentrique controle, randomise, en double insu sur groupes paralleles. Med Chir Dig 1990; 19(4): 251–5
Londong W, Barth H, Dammann HG, et al. Dose-related healing of duodenal ulcer with the proton pump inhibitor lansoprazole. Aliment Pharmacol Ther 1991; 5: 245–54
Petite JP, Grimaud JC, Rautureau J, et al. Lansoprazole versus omeprazole dans la traitement de l’ulcere duodenal evolutif [abstract]. Gastroenterol Clin Biol 1991; 15: A111
Sanders SW, Tolman KG, Greski PA, et al. The effects of lansoprazole, a new H+,K+-ATPase inhibitor, on gastric pH and serum gastrin. Aliment Pharmacol Ther 1992; 6: 359–72
Tolman KG, Sanders SW, Buchi KN, et al. Clinical pharmacokinetics and gastric pH after oral doses of lansoprazole and omeprazole. Presented at the American Gastroenterological Association; May 15-18: New Orleans, LA, 1994
Brunner G, Arnold R, Hennigs U, et al. An open trial of long-term therapy with lansoprazole in patients with peptic ulceration resistant to extended high-dose ranitidine. Aliment Pharmacol Ther 1993; 7Suppl.: 51–5
Misawa T, Chijiiwa Y, Imazono Y, et al. Effects of lansoprazole, a gastric proton pump inhibitor, on endocrine function and healing in patients with peptic ulcer. Ther Res 1991; 12(1): 175–89
Glass AR. Ketole-induced stimulation of gonadotropin output in men: basis for a potential test of gonadotropin reserve. J Clin Endocrinol Metab 1986; 63: 1121–5
Santen RJ, van den Bossche H, Symoens J, et al. Site of action of low-dose ketoconazole on androgen biosynthesis in men. J Clin Endocrinol Metab 1983; 57: 732–6
Raffer J, Sikka S, Sikka SC, et al. Mechanism of inhibition of human testicular steroidogenesis by oral ketoconazole. J Clin Endocrinol Metab 1986; 63: 1193–8
Pont A, Graybill JR, Craven PC, et al. Dismubes WE, Reitz RE, Stevens DA. High-dose ketoconazole therapy and adrenal and testicular function in humans. Arch Intern Med 1983; 144: 2150–3
Meikle AW, Bishop DT, Stringham JD, et al. Genetic and non-genetic familial factors affect the plasma content of sex-steroids in normal male twins. Metabolism 1986; 35: 1090–5
Meikle AW, Stringham JD, Woodward MG, et al. Heritability of variation of plasma cortisol levels. Metabolism 1988; 37: 514–7
Meikle AW, Stringham JD, Woodward MG, et al. Hereditary and environmental influences on the variation of thyroid hormones in normal male twins. Genet Epidemiol 1988; 5: 43–59
Odell WD, Parlow F, Cargille CM, et al. Radioimmunoassay for human follicle stimulating hormone: physiological studies. J Clin Invest 1968; 47: 2551–62
Odell WD, Ross GT, Rayford PL. Radioimmunoassay for luteinizing hormone in human plasma or serum: physiological studies. J Clin Invest 1967; 46(2): 248–55
Meikle AW, Stanish WM, Taylor N, et al. Familial effects on plasma sex-steroid content in man: testosterone, estradiol and sex hormone-binding-globulin. Metabolism 1982; 31: 6–9
Meikle AW, Stanish WM. Familial prostatic cancer risk and low testosterone. J Clin Endocrinol Metab 1982; 54: 1104–8
Urry R. Seminal fluids. In: Knight JA, Kjeldsberg CR, editors. Body fluids. The American Pathologists Press. 1986: 117–27
Cunningham GR, Silverman VE, Thornby J, et al. The potential for an androgen male contraceptive. J Clin Endocrinol Metab 1979; 49: 520–6
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This study was supported by a grant from TAP Pharmaceuticals, Deerfield, Illinois, USA.
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Meikle, A.W., Sanders, S.W., Tolman, K.G. et al. Effect of Lansoprazole on Male Hormone Function. Drug Invest 8, 191–202 (1994). https://doi.org/10.1007/BF03258478
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DOI: https://doi.org/10.1007/BF03258478