Safety of testosterone replacement therapy
Testosterone therapy is usually well-tolerated, and benefits from a wide therapeutic index. Occasional adverse events for which there is evidence of association with testosterone administration include polycythaemia (abnormally high numbers of red blood cells); acne and oily skin, particularly at the beginning of treatment and generally transient; reduced sperm production and fertility.1 Rarely, transient gynaecomastia can occur at the beginning of treatment; in isolated cases frequent or sustained erections can occur. In these cases the dose must be reduced or the preparation withdrawn in order to prevent damage resulting from a sustained erection. Use of testosterone in high doses or over prolonged periods can result in clinically insignificant changes in lipid profiles. In predisposed men (e.g. marked obesity, chronic obstructive lung disease) induction or worsening of obstructive sleep apnea may occur rarely.1 The sleep apnea disappears when the testosterone therapy is discontinued.
Contraindications and Precautions
- Testosterone replacement therapy should only be administered if testosterone deficiency (hypogonadism) has been established and other aetiology that may be responsible for the signs and symptoms has been excluded.1-4 Such causes may included: pituitary tumor; hypopituitarism; diabetes insipidus; Alzheimer’s disease, vascular dementia; hypothyroidism; partial deficiency of adrenocorticotropic hormone; acute infection, inflammatory disease.
- Although there are no clear indications that androgens actually generate prostatic carcinoma, they can enhance the growth of any existing prostatic carcinoma. Therefore carcinoma of the prostate has to be excluded before starting therapy with testosterone preparations.1-4
- Androgens must not be given to patients with androgen-dependant male breast cancer. As androgens are aromatised to oestrogens, androgen therapy can stimulate proliferation of an oestrogen-receptor-positive breast carcinoma.1-4
- As testosterone replacement therapy can be associated with an increase in haematocrit it should be avoided in patients with polycythaemia.1-4
- Because testosterone replacement therapy impairs production of sperm, it should be used with caution in men with fertility concerns.1
- Testosterone replacement therapy is not recommended for use in children. In adolescents, although testosterone therapy may be indicated (e.g. in delayed puberty or other forms of primary or secondary testosterone deficiency), not all currently available testosterone preparations are approved for use in adolescents. Regulations relevant to your country of practice should be consulted.
- Other conditions that can potentially be made worse by testosterone therapy include severe lower urinary tract symptoms associated with benign prostatic hypertrophy, severe congestive heart failure, and liver or renal disease.1-4
- Bhasin S, Cunningham GR, Hayes FJ, Matsumoto AM, Snyder PJ, Swerdloff RS, Montori VM; Task Force, Endocrine Society. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2010 Jun;95(6):2536-59. doi: 10.1210/jc.2009-2354. Review.
- Qoubaitary A, Swerdloff RS, Wang C. Advances in male hormone substitution therapy. Expert Opin Pharmacother 2005; 6(9): 1493-506
- Seftel A. Testosterone replacement therapy for male hypogonadism: part III. Pharmacologic and clinical profiles, monitoring, safety issues, and potential future agents. Int J Impot Res 2007; 19(1): 2-24
- ISA, ISSAM, EAU, EAA and ASA recommendations: investigation, treatment and monitoring of late-onset hypogonadism in males. Wang C, Nieschlag E, Swerdloff RS, Behre H, Hellstrom WJ, Gooren LJ, Kaufman JM, Legros JJ, Lunenfeld B, Morales A, Morley JE, Schulman C, Thompson IM, Weidner W, Wu FC. Aging Male. 2009 Mar;12(1):5-12. doi: 10.1080/13685530802389628