Testosterone Undecanoate Safe

TORONTO —Testosterone undecanoate administered every three months is a safe treatment for hypogonadal men, according to a four-year study. 

Parenteral testosterone undecanoate (TU) was administered to 25 men  (mean age 35 years) at 1000 mg every 12 weeks. These men were part of a larger study of 40 men that TU with testosterone enanthate for 30 weeks. Plasma testosterone, body weight, BMI, and waist-to-hip ratios remained stable during four years of follow-up, as did total cholesterol, triglycerides, and lipoprotein (a).

Plasma LDL cholesterol declined, however, whereas HDL cholesterol increased significantly after three years of treatment. In ad-dition, apoliprotein A1 and B decreased significantly. BP, bone mineral density, hemoglobin, hematocrit, and liver function also remained stable.

Over the first 12 months of the study, researchers observed an increase in mean prostate volume from 19.7 to 22.0 mL, but volumes remained stable thereafter, said investigator Susanna Freude, MD, a fifth-year resident at the University of Cologne in Germany. She reported study findings here at the 89^th annual meeting of The Endocrine Society.

During the first 12 months, mean PSA levels rose from 0.27 to 0.75 ng/mL. Prostate volume and PSA increases may be an expression of normalization of values from a hypogonadal state, Dr. Freude said. Parenteral testosterone undecanoate already is commercially available in Australia and Europe (EC) and it is expected to be commercially available in the United States within the next 12 to 18 months.