Is 2% Testosterone Solution Safe and Effective for Men with Androgen Deficiency?

A 2% testosterone solution (T-sol) improved the sex drive and energy levels in men with hypogonadism, according to a recent 2-phase study.

During the first, double-blind phase of the study, 275 men were assigned placebo and 283 were assigned an active treatment with T-sol. After 3 months, the researchers found that T-sol was safe and effective for improving sex drive in men with androgen deficiency.

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Then, for the second arm of their study, the researchers conducted an open-label treatment study in which they assigned all 558 men an active treatment with T-sol for 6 months.

The researchers tracked the number of men with normal levels of total testosterone; measured treatment-induced change in sex drive according to the Sexual Arousal, Interest, and Drive scale; and assessed treatment-induced change in energy according to the Hypogonadism Energy Diary.

At the end of the open-label phase of the study, 60% of men who were formerly on placebo and 66% of men who continued with T-sol treatment had total testosterone levels within normal range.

In addition, both groups reported improvement in Sexual Arousal, Interest, and Drive score and Hypogonadism Energy Diary score, and no safety concerns were 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 researchers concluded.

—Amanda Balbi

Reference:

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 [published online April 23, 2016].  J Urol. doi:http://dx.doi.org/10.1016/j.juro.2016.04.065.