Studies show positive results of TRT gel formulations in obese, diabetic men

Two testosterone gel formulations are efficacious in obese men and those with diabetes, according to separate studies reported at the Endocrine Society annual meeting in San Francisco.

Data evaluated by UCLA Medical Center researchers showed that initial treatment response of hypogonadal men who used testosterone gel 1% CIII (AndroGel) had similar effects on subjects, independent of weight and body mass index.

“Multiple studies have shown that obese men are at an increased risk of having low testosterone levels, so these new findings provide important insight into optimal treatment regimens for hypogonadal men,” said lead author Christina Wang, MD.

The analysis is part of a new subset evaluation of a 6-month safety and efficacy study of AndroGel published in 2000. The current study examined the relationship between BMI and sex hormones in hypogonadal men before and after treatment with testosterone, and found that neither testosterone nor free testosterone is significantly related to BMI either before or after testosterone treatment.

Dr. Wang has served as an adviser to Solvay Pharmaceticals.

In a second study, researchers showed that testosterone replacement therapy can significantly improve insulin sensitivity and sexual function in hypogonadal men with type 2 diabetes and/or metabolic syndrome.

“The finding that testosterone replacement therapy improves insulin sensitivity in a placebo-controlled study and that the effect persists over the 12-month treatment period is a very important clinical finding,” said lead author Hugh Jones, MD, of the University of Sheffield Medical School in the United Kingdom.

The double-blind, placebo-controlled TIMES2 study of 220 hypogonadal men 40 years of age and older encompassed eight European countries in a 12-month period. The primary endpoint was to measure the effect of 2% testosterone gel (Tostran [not currently available in the United States]) on insulin sensitivity at 6 and 12 months.

Principal results of study, which was sponsored by ProStrakan Group plc, were:
• A significant improvement in insulin sensitivity was observed among those using testosterone gel compared with placebo after six months; this was maintained at 12 months.
• Those using the testosterone gel saw significant improvement in sexual function at 6 and 12 months.
• The testosterone gel treatment was well tolerated.