Men with primary or secondary hypogonadism assigned to testosterone replacement injection therapy reached normal levels of testosterone that remained consistent for 64 weeks, according to phase 3 study data presented here.
In the phase-3, open-label study, researchers assigned 130 men with serum testosterone levels less than 300 ng/dL to 750 mg testosterone undecanoate as an intramuscular injection (Endo Pharmaceuticals). Testosterone injection was administered at baseline, week four and then every 10 weeks after for a total of 84 weeks, or eight injections. This update includes effects on sex hormones through the end of the seventh injection interval (64 weeks).
After the first injection, eugonadal serum testosterone levels increased rapidly and the effect was maintained. Mean testosterone concentrations remained in the normal range — 300 ng/dL to 1,000 ng/dL — throughout the study period. Once steady values of free testosterone, sex hormone-binding globulin, dihydrotestosterone and estradiol were attained, the effect remained relatively consistent. The ratio of sex hormones to testosterone also remained constant.
Only having to inject every ten weeks would be very convenient for HRT purposes.
I'm confused why Endo Pharmaceuticals and not Schering is conducting these trials in the USA. Schering's Testosterone Undecanoate injection Nebido is already available in several countries.
Indevus bought the rights to distribute Nebido in the U.S. Then Indevus was bought by Endo Pharmaceuticals Inc. on March 23, 2009.
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