MALVERN, Pa., Nov. 3, 2011 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) today announced the release of clinical practice data from the Testim Registry in the United States (TRiUS). This study showed that daily administration of Testim® 1% (testosterone gel) resulted in significantly improved sexual function and increased total testosterone levels in men with hypogonadism, often referred to as low testosterone. Sexual function assessments from TRiUS, which followed patients in clinical practice for a 12-month period, were published in the November issue of the Journal of Sexual Medicine.
"These data are an important look at testosterone replacement therapy's (TRT) impact on sexual function in hypogonadal men," said Mohit Khera, M.D., Director of the Laboratory for Andrology Research at Baylor College of Medicine and lead study investigator. "The improved level of sexual function seen in the study participants suggests that the increases of total testosterone achieved with TRT may correlate with the improvement in their self-reported sexual function."
Investigators assessed data from 271 TRiUS patients and evaluated the correlation between changes in the patients' Brief Male Sexual Function Inventory (BMSFI) scores and their mean total testosterone levels after 12 months of Testim therapy. The BMSFI assessed patients' self-reported sexual drive/libido, erectile function, ejaculatory function, and level of bother/sexual problems. After 12 months of TRT, mean total BMSFI scores significantly increased from baseline from 27.4 +/- 10.3 to 33.8 +/- 9.8 (P < 0.001) and mean total testosterone concentrations increased from 9.28 +/- 4.84 to 17.37 +/- 8.61 nmol/L (p<0.001). Regression analysis indicated that the increased total BMSFI score was significantly associated with increased total testosterone levels.Significant improvement in sexual function from baseline scores was also seen in a subset of study participants concurrently using PDE5 inhibitors (for example, Viagra® and Cialis®) for erectile dysfunction (ED). Patients on PDE5 inhibitors had significantly lower baseline sexual function scores than other participants, but these scores improved after six and 12 months of TRT.