The essential aim of testosterone replacement therapy is to restore serum testosterone to the middle of the normal physiological range and to minimise the signs and symptoms of testosterone deficiency (hypogonadism).1-4 In all types of male hypogonadism testosterone replacement therapy forms the core of the treatment. A number of different androgen preparations and dosage forms are available, and treatment can be individualised to correct the testosterone deficiency in primary and secondary hypogonadism and to enhance patient health and well-being.1-4
Testosterone therapy is usually well-tolerated. Treatment can be initiated when a diagnosis of testosterone deficiency has been confirmed and contraindications ruled out. Close monitoring of the treatment is essential. Several months of treatment may be required before changes are apparent.
Currently marketed treatment options for testosterone replacement therapy for male hypogonadism are summarised below.
An ideal preparation of testosterone will raise testosterone levels back into the mid-normal range to reverse the symptoms of testosterone deficiency. It will also be well tolerated and offer a convenient dosing schedule and means of administration at a reasonable cost. 1-4
Intramuscular injections of testosterone enanthate, have previously been the standard form of testosterone therapy in male hypogonadism. More recent developments have brought about the availability of long-acting injectables such as testosterone undecanoate. Such preparations provide more stable physiological levels of testosterone and offer good patient compliance.
The transdermal gel/solution contains native testosterone in a clear and colorless formulation which is absorbed by the skin within a few minutes after the morning application to the upper arms, shoulders and abdomen. The serum testosterone concentration remains very reliably within the normal range for 24 hours after application.2
Oral testosterone undecanoate has the convenience of oral administration without the same potential for liver toxicity as another oral testosterone formulation, 17-α-testosterone.1-3 A short duration of action requires 2-3 times daily dosing, and clinical responses can be less consistent than with the long-acting injectable formulation of testosterone undecanoate or the testosterone gel.1,2
- 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