Testosterone Solution Safety Tested in 6-Month Trial of Androgen Men
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 six 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.