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Testosterone injection sustained normal testosterone levels in men with hypogonadism
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The Endocrine Society's 91st Annual Meeting
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.
“Once diagnosed, long-term injections offer patients a safe, effective and convenient new option,” Ronald Swerdloff, MD, of the David Geffen School of Medicine at the University of California Los Angeles, said in a press release.
In the phase-3, open-label study, researchers assigned 130 men with serum testosterone levels <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.
The most commonly reported adverse events associated with this type of testosterone injection are mild acne and increased prostate specific antigen, according to safety analyses in another study.
Long-acting testosterone undecanoate injection was first approved in Europe in 2003 and is now marketed in more than 80 countries (Nebido, Bayer Schering Pharma). The new injection is currently pending FDA approval in the United States. – by Jennifer Southall
For more information:
- Wang C. #P2-358. Presented at: The Endocrine Society’s 91st Annual Meeting; June 10-13, 2009; Washington, D.C.