Laird Harrison

May 20, 2013

SAN DIEGO, California — Replacing testosterone in men with late-onset hypogonadism can improve their quality of life, a new phase 3 clinical trial shows.

The ability to carry out physical and emotional roles improved in men who received testosterone replacement and declined in men who did not, said Hiroyuki Konaka, MD, from Kanazawa University in Japan.

Dr. Konaka presented the study results here at the American Urological Association 2013 Annual Scientific Meeting.

"Whether androgen-replacement therapy can improve healthcare and prolong an active lifestyle" is a matter of debate, he noted.

"Several studies have looked at the effect of androgen-replacement therapy on late-onset hypogonadism in Western countries, but most were small-scale and short-term studies," Dr. Konaka pointed out. No large randomized controlled trials have been conducted in Asian populations.

To fill that gap, Dr. Konaka and his team randomized 334 men who were 50 to 90 years of age and had a serum free testosterone level below 11.8 pg/mL to 1 of 2 groups. A total of 169 men received up to 12 intramuscular injections of testosterone enanthate 250 mg every 4 weeks, and 165 men were part of the control group.

All the men were Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2, meaning they were ambulatory and able to take care of themselves.

After 52 weeks, the men who received testosterone replacement experienced significant improvement in muscle volume, voiding, physical role functioning, and erectile function, such as ability to penetrate, measured on the International Index of Erectile Function.

In addition, there was a trend toward improvement in emotional role functioning (measured with the SF-36).

Table. Change From Baseline After 52 Weeks of Testosterone Therapy

End Point P Value
Improved physical role functioning .0318
Improved emotional role functioning .0727
Improved voiding .0418
Improved erectile function .0049
Decreased waist circumference .0051
Increased whole-body muscle volume .0108

 

The men in the control group experienced no declines or statistically significant changes in any of these measures. In fact, in these men, waist circumference increased.

Testosterone replacement is less common in Japan than in Western countries, in part because Japanese health insurance covers only injections, not the gel form of the medication, Dr. Konaka told Medscape Medical News.

In addition, there is reason to believe that the treatment works differently in Japanese men than in men of European origin. "Hormone therapy is very, very effective for Japanese men with prostate cancer," he explained, "so they might have a different response to hormones."

Session moderator Irwin Goldstein, MD, president of the Institute for Sexual Medicine in San Diego, California, questioned whether 52 weeks can be considered "long-term."

But he praised the researchers for measuring aspects of mental health as part of the study. "The emphasis on cognition and mood is fabulous," Dr. Goldstein said. "It really is a concern of aging people that their brain function is good."

Dr. Kanaka and Dr. Goldstein have disclosed no relevant financial relationships.

American Urological Association (AUA) 2013 Annual Scientific Meeting: Abstract 1236. Presented May 6, 2013.

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