New York, NY, August 17, 2016 - For men with hypogonadism, a condition in which the body does not produce enough testosterone, low sex drive and fatigue are common symptoms. For these men treatment with a 2% testosterone solution (T-sol) can be effective therapy. In a six-month open-label study of patients receiving T-sol, published in The Journal of Urology®, researchers noted improvement of low sex drive and low energy symptoms, and did not identify new safety concerns.
Testosterone replacement therapies have proven effective in normalizing serum testosterone levels in androgen deficient men, but some safety concerns have been reported. Following a three-month double-blind placebo-controlled study, 558 hypogonadal men entered a six-month open-label study to evaluate the safety and efficacy of continued T-sol treatment. 275 of the participants had previously received placebo and 283 had received active treatment with T-sol during the earlier double-blind phase of the study.
Patients completed two self-reported surveys to assess sex drive and energy, the Sexual Arousal, Interest and Drive survey that rates the degree of sexual thought, arousal and sexual interest and drive, and the Hypogonadism Energy Diary that captures patient responses regarding the extent to which a respondent feels energetic or has feelings of tiredness/exhaustion.
According to lead investigator Gerald Brock, MD, of the Department of Surgery, University of Western Ontario, London, ON, Canada, "Results from this study demonstrate that long-term treatment with T-sol successfully supplements testosterone levels in the majority of recipients. Testosterone levels in 60% of the former placebo participants and 66% of the continuing active participants were within the normal range at the end of the open-label study. Furthermore, the safety profile was consistent with the safety outcomes of the double-blind phase and other trials using T-sol."
The study found that patients who received T-sol during the open-label phase had improved symptoms regardless of whether they had received placebo during the blinded phase. Those who had received T-sol in the blinded phase also continued to improve, suggesting that T-sol treatment efficacy does not plateau in the first few months. Treatment with T-sol for up to nine months was generally well tolerated and six months of extended treatment not only maintained the improvement of low sex drive and low energy seen in the double-blind phase, but also continued to improve these symptoms.