Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.
For this indication, competent medicine agencies globally authorize below treatments:
Intramuscular
1,000 - 1,000 mg
From 1,000 To 1,000 mg once every 70 day(s)
1000 mg testosterone undecanoate is injected every 10 to 14 weeks. Injections with this frequency are capable of maintaining sufficient testosterone levels and do not lead to accumulation.
Serum testosterone levels should be measured before start and during initiation of treatment. Depending on serum testosterone levels and clinical symptoms, the first injection interval may be reduced to a minimum of 6 weeks as compared to the recommended range of 10 to 14 weeks for maintenance. With this loading dose, sufficient steady state testosterone levels may be achieved more rapidly.
The injection interval should be within the recommended range of 10 to 14 weeks. Careful monitoring of serum testosterone levels is required during maintenance of treatment. It is advisable to measure testosterone serum levels regularly. Measurements should be performed at the end of an injection interval and clinical symptoms considered. These serum levels should be within the lower third of the normal range. Serum levels below normal range would indicate the need for a shorter injection interval. In case of high serum levels an extension of the injection interval may be considered.
The injections must be administered very slowly (over two minutes). Care should be taken to inject testosterone deeply into the gluteal muscle following the usual precautions for intramuscular administration. Special care must be taken to avoid intravasal injection.
Oral
40 - 160 mg
From 20 To 80 mg 2 time(s) per day every day
120 mg
The initial dosage required will usually be 120-160 mg daily for 2-3 weeks. Subsequent dosage (40-120 mg daily) should be based on the clinical effect obtained during the first weeks of therapy.
To ensure absorption, testosterone must be taken with a normal meal, if necessary with a little fluid, and be swallowed whole without chewing. It is preferable that half of the daily dose be taken in the morning and the other half in the evening. If an uneven number of capsules is taken daily, the greater part should be taken in the morning.
Cutaneous
50 - 100 mg
From 50 To 100 mg once every day
50 mg
The recommended dose is 50 mg of testosterone applied once daily at about the same time, preferably in the morning. The daily dose should be adjusted by the doctor depending on the clinical or laboratory response in individual patients, not exceeding 100 mg of testosterone per day. The adjustment of posology should be achieved by 25 mg of testosterone gel steps.
The application should be administered by the patient himself, onto clean, dry, healthy skin over both shoulders, or both arms or abdomen.