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 in: The Journal of urology
• Main Authors: Brock, Gerald, Heiselman, Darell, Knorr, Jack, Ni, Xiao, Kinchen, Kraig
• Format: Journal Article
• Language: English
• Published: 2016
• Subjects: Urology; open label extension; TT; testosterone replacement therapy; myocardial infarction; OLE; libido; SAID; LC-MS/MS; Sexual Arousal, Interest, and Drive scale; TSAT; TRT; liquid chromatography tandem mass spectrometry; total testosterone; MI; HbA1c; energy; BMI; PSA; T-sol; testosterone; AE; body mass index; HED; adverse event; prostate specific antigen; cardiovascular; testosterone solution 2; hypogonadism; CV; Hypogonadism Energy Diary; I-PSS; drive; hemoglobin A1c; International Prostate Symptom Score; Testosterone Solution in Hypogonadal Men
• ISSN: 0022-5347
• DOI: 10.1016/j.juro.2016.04.065

Purpose We evaluated 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 in which T-sol was safe and efficacious for sex drive in men with androgen deficiency. Materials and Methods A total of 558 hypogonadal participants with a mean (SD) age of 55 (11) years entered the open label treatment study. Of these 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 At the completion of the open label phase 60% and 66% of the participants had total testosterone levels within the normal range in the formerly placebo and continuing active groups, respectively. Participants assigned to both groups showed baseline to end point 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. No new safety concerns were reported. Conclusions 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.