Testosterone solution improves sex drive, energy in hypogonadal men
Treatment with testosterone solution 2 percent (T-sol) for 6 months was generally well tolerated and did not show new safety concerns, according to a study. In addition, the outcomes of low sex drive and low energy indicated further improvement after the double-blind phase.
“[Six] months of extended treatment with T-sol not only maintained the improvement in low sex drive and low energy seen in the double-blind phase, but also continued to be associated with improving these symptoms,” according to researchers.
To assess the safety and efficacy of T-sol, researchers enrolled 558 hypogonadal participants (mean age 55 years) in a 6-month open label treatment study. Of the patients, 275 had previously received placebo (formerly placebo group) and 283 had received active treatment with T-sol (continuing active group) during the double-blind phase.
Outcome measures were the proportion of men with total testosterone levels within the normal range; assessment of treatment induced change in sex drive measured using the Sexual Arousal, Interest, and Drive scale; and assessment of treatment induced change in energy measured using the Hypogonadism Energy Diary.
“Results from this study demonstrate that long-term treatment with T-sol successfully supplements testosterone levels in the majority of recipients,” researchers said.
After completing the open label phase, 60 and 66 percent of the participants had total testosterone levels within the normal range in the formerly placebo and continuing active groups, respectively.
Men assigned to both groups showed baseline-to-endpoint improvement in Sexual Arousal, Interest, and Drive score (both p<0.001) and Hypogonadism Energy Diary score (both p<0.001) during the open label phase. There were no safety concerns identified.