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Researchers at the University of Western Ontario published the results of the testosterone clinical trial showing Testosterone increases sex drive and energy without adverse side effects.  The positive results lasted the entire period of this nine month, double blind trial including the three month double blind placebo period.  

The testosterone clinical trials showed no plateauing of sex drive or energy at any point in the program for the 558 men in the program.  

Researchers Drs Loughlin and Klap wrote that, “interest in testosterone-replacement therapy continues to intensify” — shown by the 3x increase in testosterone prescriptions from 2001 to 2011 among men in the US aged 40 years or older and expected growth from $2B to $5B from 2014 to 2017.  Patient demand and patient results is what is driving all of this interest.

FDA and EU Guidelines

The US FDA says testosterone shouldn’t be used in men who don’t have hypogonadism.  The FDA states this because the benefit/risk profile for use hasn’t been established, including cardiovascular risks, which remain unknown. However, the EU medicines agency took a very difference position concluding there is “no consistent evidence” for increased heart risk when taking testosterone treatments.  Dr. Block stated his conclusions from the research are that “there was absolutely no evidence of any concerning end point in this study — no cardiovascular signal whatsoever”.

Testosterone Clinical Trial

There were 558 testosterone clinical trial participants who averaged 55 years of age.  In the open-label extension phase during the last six months of the trial, 275 had previously received placebo and 283 had been treated with testosterone. They patients were collected from a large number of different racially constructed countries, including from ones in North and South America, Europe, and South Korea.

 Trial participants from both groups contained similar baseline statistics.  In order to qualify for the trial, the participants had to be male and had to be 18 years+.  These trial prospects had two total testosterone tests below 300 ng/dL measured a week or more apart from each other and had to exhibit at least one of the symptoms of low testosterone deficiency.

At the conclusion of the testosterone clinical trial, 60% of the group that started on a placebo and 66% of the group starting initially on Testosterone Replacement Therapy had normal testosterone levels.

Increased HED and SAID Scores

Testosterone clinical trial participants completed two Qualitative surveys: the SAID (Sexual Arousal, Interest and Drive) and HED (Hypogonadism Energy Diary) surveys.

The actual Testosterone solution trial phase saw significantly improved SAID scores during the secondary open-label phase.  Very interestingly these saw these results in both the formerly placebo and continuing-active testosterone groups.   The placebo group average change was 17.5 and in the continuing-active group it was 9.3 (P < .001 for both groups). This meant that testosterone improved across the SAID survey: sex drive, arousal, and erectile function.

Testosterone also improved HED scores from beginning to end: the formerly placebo group average improvement was 8.9 and for the continuing-active group was 5.1 (P < .001 for both groups).

The SAID and HED qualitative questionnaires help us to understand the improvement and clinical management of the participants.

 The testosterone clinical trial showed no significant changes over the 36 weeks in body mass index, HbA1c, or insulin sensitivity for either group.

“For the first time, we really have an understanding of what treatment with testosterone does to those men who become normalized in terms of their testosterone level,” Dr Brock commented.


Is It Low T?

Dr Brock believes many untrained PCPs have trouble diagnosing patients who report low energy or low sexual interest if its a thyroid problem, depression, or just old age.   “In the past 10 years many of us have begun to recognize that it may be, in some of these men, a direct effect of having low testosterone,” he said.

Results and leanings from another placebo-controlled testosterone clinical trial, multicenter Testosterone Trial, indicates testosterone treatment in older men may help improve sexual function, mood, depressive symptoms, and possibly walking distance, but it doesn’t seem to improve vitality.

 This test however, did not take allowance for different ages Hence, the pressing need for proper quantification of age-adjusted testosterone levels, add Drs Loughlin and Klap, “because it is not unreasonable to posit that some of the explosion in testosterone products is due to the fact that some older men are being diagnosed as ‘hypogonadal’ based on serum levels that apply to men who are decades younger.”



Testosterone Clinical Trial Proves Increased Energy and Sex Drive

Saleamp Design August 25th, 2016

Posted In: Uncategorized

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