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Topical vs. injected Testosterone
May 2, 2011

Hi. Thanks for your always useful advice. In your advice in the post of 11 April about Compounded vs. Injection based Testosterone you compare Testosterone gel to Testosterone injections given every one or two weeks and mentioned a new product, Aveed, which may be given less frequently. But there is already such products: Nebido which is given every three months (but is very costly) and an Indian product, Testosterone Bucilate, which is given every four months. I would appreciate your advice with respect to the latter products.

Best regards

Response from Mr. Vergel

Nebido and testosterone buciclate are not approved yet in the United States. Nebido(testosterone undecanaotae) will be called Aveed in the United States when it gets approved.

You did not mention what country you live in, though.

TESTOSTERONE BUCICLATE

This long acting testosterone injectable ester last longer than other injectable any in the body. For this reason, it has been studied by the World Health Organization as a male contraceptive, since testosterone injections can lower sperm counts and this option would require fewer injections per year. The studies were done in the 1990's but no pharmaceutical company picked up the rights in the United States. A search in clinicaltrails.gov found no current studies. Some internet sites sell the product but I do not know their quality. It is illegal to order testosterone or anabolic steroids on the internet in the United States, even for people with HIV who have a prescription. Although it is almost impossible for customs to intercept all packages, it does happen. You may not go to jail but will have a warning sent to your house as they intercept and throw away your order.

This testosterone ester stays in the body for a few weeks after one injection. A study done using intramuscular injection of 600 mg of T buciclate to hypogonadal men produced serum testosterone concentrations within the normal range for about 8 weeks with a terminal elimination half- life of 29.5 days (day when only half of the product remains in the body) . Serum dehydrotestosterone (DHT) concentrations were within the normal range; estradiol was only slightly increased above normal; sex hormone binding globulin (SHBG) did not change; and gonadotropins (LH and FSH) were significantly suppressed. No adverse biochemical or prostate responses were re- ported. It is unknown if this preparation will find use for male contraceptive therapy or replacement for hypogonadism.

TESTOSTERONE UNDECANOATE

This option may get approve within the next few months in the United States with the brand name Aveed. It is sold in many countries as Nebido.

Intramuscular injections of 500 and 1000 mg of testosterone undecanoate (TU) in hypogonadal men resulted in increased mean serum T levels from less than 10 nmol/L to 47.8 and 54.2 nmol/L, respectively, after about 1 week. Thereafter, serum T levels decreased progressively and reached the lower-normal limit for adult men by day 50 and 60 and had a terminal elimination half-life of 18.3 and 23.7 days, respectively. Estradiol and DHT followed the pattern of T and remained within normal limits. In these short-term studies, no serious side effects were noted.

Aveed will most probably get approved after the company proves that the coughing caused by the injections in a few people is not related to the product but to injection technique. Anaphylactic reactions are common side effects with all approved testosterone injectables due to bad injection technique, so it is amazing that the FDA delayed the approval of Aveed based on a side effect that is well known with currently available testosterone products in the United States. Common symptoms of anaphylactic reactions with testosterone injections are cough and dizziness that subside after a few minutes. It is believed that this happens when testosterone enters the blood stream and ends up in the lungs (injections are meant to form a "pocket" for slow release in the muscle. Some people may inject in a blood vessel and have anaphylactic reactions). I have had this reaction and found a quick solution to it: breathe into a paper bag until the cough stops.

Nelson



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