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

The objective of the current study was to evaluate the continued safety and efficacy of testosterone solution 2% (T-sol) in a 6-month open-label extension study following a 3-month double-blind, placebo-controlled study where T-sol was safe and efficacious for sex drive in androgen-deficient men.

A total of 558 hypogonadal participants, mean (±standard deviation) age of 55 (11) years, entered the open-label treatment study; 275 had previously received placebo (formerly placebo) and 283 had received active treatment of T-sol (continuing active) 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.

At completion of the open-label phase, 60% and 66% of the participants had total testosterone levels within the normal range for formerly placebo and continuing active groups, respectively. Participants assigned to both groups showed baseline to endpoint improvement in Sexual Arousal, Interest, and Drive scores (both p < 0.001) and Hypogonadism Energy Diary scores (both p < 0.001) during the open-label phase. No new 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 following the double-blind phase.

The Journal of urology. 2016 Apr 23 [Epub ahead of print]

Gerald Brock, Darell Heiselman, Jack Knorr, Xiao Ni, Kraig Kinchen

Department of Surgery, University of Western Ontario, London, ON, Canada. Electronic address: ., Eli Lilly and Company, Indianapolis, IN, USA., Eli Lilly and Company, Indianapolis, IN, USA., Eli Lilly and Company, Indianapolis, IN, USA., Eli Lilly and Company, Indianapolis, IN, USA.

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