A new study reveals that treatment with testosterone solution 2% (T-sol [Axiron]) can be effective for hypogonadism with no new safety concerns.
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“I think we all recognize that there’s a huge number of men out there who have some form of or symptoms related to testosterone deficiency, and the idea of the study was to look at if we could assess some of the important aspects of effective therapy on these men and give us information about sexual interest and sexual drive and overall energy. Those are some of the aspects that haven’t really been assessed in an objective way prior to this study and I think that has real value for us,” lead author Gerald Brock, MD, of the University of Western Ontario, London, ON, told Urology Times
The study, which was published online in The Journal of Urology (April 23, 2016),
evaluated the continued safety and efficacy of T-sol in a 6-month open-label extension study following a 3-month, double-blind, placebo-controlled study in which T-sol was found safe and efficacious for sex drive in men with androgen deficiency.
Read - TTrials: T therapy improves sexual desire, activity
In all, 558 hypogonadal men were evaluated, with 275 of the participants previously receiving the placebo and 283 receiving active treatment with T-sol during the earlier double-blind phase of the study. Dr. Brock noted participants assigned to both groups showed baseline-to-endpoint improvement in sexual arousal, interest, and drive score.
Next: Results from the study
The results revealed that 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. Furthermore, the outcomes of low sex drive and low energy showed further improvement after the double-blind phase.
Also see: Long-term TRT use reduces risk of CV events, PCa
“As a clinician, I see these patients all the time, and the sense is men who are testosterone deficient complain about low energy, low sexual interest, low sexual drive, and some complain about erectile dysfunction. Certainly, we have good questionnaires to ask about erectile dysfunction but we didn’t really have a way previous to this study of assessing some of those other softer endpoints,” Dr. Brock said.
Still, Dr. Brock feels there’s still controversy surrounding testosterone. While he believes most clinicians are comfortable now with the idea that testosterone treatment doesn’t cause prostate cancer, there are still recent issues related to cardiovascular effects of testosterone supplementation.
“This study was nice because though there wasn’t an endpoint, there was no signal of any cardiovascular events related to testosterone therapy,” he said. “We saw that the vast majority of men who were treated actually had a positive benefit of treatment, as quantified by the tendencies we were looking at, and overall we didn’t see any adverse effects in terms of blood pressure or anything we would be looking at in an everyday practice.”
Dr. Brock has a financial interest and/or other relationship with Eli Lilly and Co., Pfizer, Johnson and Johnson, and Astellas Pharma. Dr. Brock’s co-authors have a financial interest and/or other relationship with Eli Lilly and Co.
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