2 Percent Daily Testosterone Shows 6-Month Efficacy
Once-daily T-sol administered for 6 months did not indicate new safety concerns, and the outcomes of low sex drive and low energy showed further improvement.
HealthDay News — Once-daily testosterone solution 2% (T-sol) is safe and improves sex drive and energy in men with androgen deficiency, according to a study published in the November issue of The Journal of Urology.
Gerald Brock, MD, from the University of Western Ontario in London, Canada, and colleagues evaluated the continued safety and efficacy of T-sol in a 6-month open-label extension study after a 3-month, double-blind, placebo-controlled study of the safety and effectiveness of T-sol in 558 men (mean age 55 years) with androgen deficiency.
The researchers studied 275 men who had previously received placebo (formerly placebo group) and 283 men continuing active T-sol treatment. At the end of the study period, 60 and 66% of the participants, respectively, had total testosterone levels within the normal range. Participants in both groups showed significant baseline to end point improvement in sexual arousal, interest, and drive score and Hypogonadism Energy Diary score. There were no new safety concerns reported.
"Once-daily T-sol administered for 6 months in an open-label study did not indicate new safety concerns, and the outcomes of low sex drive and low energy showed further improvement after the double-blind phase," the authors write.
All authors disclosed financial ties to pharmaceutical companies, including Eli Lilly, which assisted with trial administration and the writing and editing of the manuscript.
Brock G, Heiselman D, Knorr J, et al. 9-Month efficacy and safety study of testosterone solution 2% for sex drive and energy in hypogonadal men. Urology. Nov 2016. DOI: http://dx.doi.org/10.1016/j.juro.2016.04.065