(HealthDay News) — Once-daily 2% testosterone solution (T-sol) is safe and effective for sex drive and energy in hypogonadal men, according to a study published online in The Journal of Urology.
Gerald Brock, MD, from the University of Western Ontario in London, Canada, and colleagues examined the continued safety and efficacy of T-sol in a 6-month open-label extension study following a 3-month placebo controlled study. Five hundred fifty-eight hypogonadal participants (mean age, 55 years) were enrolled in the open-label study. Of these, 275 and 283 had previously received placebo and T-sol, respectively, in the double-blind phase.
The researchers found that 60 and 66% of the participants in the formerly placebo and continuing active treatment groups, respectively, had total testosterone levels within the normal range at the completion of the open-label phase. During the open-label phase, there were baseline to end point improvements for both groups in the Sexual Arousal, Interest, and Drive score (both P < 0.001) and Hypogonadism Energy Diary score (both P < 0.001). There were no reports of new safety concerns.
“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.
Several authors disclosed financial ties to pharmaceutical companies, including Eli Lilly, which assisted with trial administration.
1. Brock G, Heiselman D, Knorr J, Ni X, Kinchen K. 9-Month Efficacy and Safety Study of Testosterone Solution 2% for Sex Drive and Energy in Hypogonadal Men: Results of a 6-Month Open Label Extension of a 3-Month Double-Blind Study. J Urol. doi: 10.1016/j.juro.2016.04.065.