TTrials: T therapy improves sexual desire, activity

Testosterone therapy improves sexual desire and sexual activity among older men with low libido and low testosterone levels, according to a recent study.  

One men’s health expert praised the study, although he noted the advanced age of the participants as a possible limitation.

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The double-blinded sexual function study is part of the Testosterone Trials (“TTrials”) and is the largest placebo-controlled trial in older men to date to examine the effect of testosterone therapy on sexual function, according to a press release from the Endocrine Society. The findings were published online in the Journal of Clinical Endocrinology & Metabolism(June 29, 2016). Additional findings from the TTrials were published earlier this year in the New England Journal of Medicine (2016; 374:611-24).

The authors studied 470 men at 12 academic medical centers. Subjects were at least 65 years of age and had low libido, with an average testosterone level of less than 275 ng/dL. All the men had a heterosexual partner who was willing to have sexual intercourse at least twice per month.

In the 12 months of the study, subjects received either topical testosterone gel 1% (AndroGel) in a pump bottle, with an initial dose of 5 grams daily, or placebo gel. The authors measured serum testosterone concentrations at 1, 2, 3, 6, and 9 months, adjusting testosterone gel after each measurement to try to maintain a concentration within the normal range for young men, according to the study.

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Those participating answered questionnaires about sexual function at baseline and every 3 months for a year. Researchers assessed sexual function by having subjects complete the Psychosexual Daily Questionnaire, the Derogatis Interview for Sexual Functioning, and the International Index of Erectile Function.

Next: Consistent improvement in libido seen

The authors found that men in the testosterone therapy arm had consistent improvement in libido and in 10 of 12 sexual activity measurements, including frequency of intercourse, masturbation, and nighttime erections. In comparison, questionnaire responses among men in the placebo group did not change significantly over the course of the study. Incremental increases in total and free testosterone and estradiol levels, they found, were associated with improvements in sexual desire and activity, but not erectile function. The authors found no evidence of a threshold effect.

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“Our findings indicate low testosterone is one cause contributing to reduced libido and erectile dysfunction in older men. Men experiencing these symptoms should be evaluated for testosterone deficiency,” said first author Glenn R. Cunningham, MD, of Baylor College of Medicine and Baylor St. Luke’s Medical Center in Houston.

Urology Times Editorial Council member James M. Hotaling, MD, MS, of the Center for Reconstructive Urology and Men’s Health, University of Utah, Salt Lake City, said the study is well done and has impressively strict inclusion criteria. Where it might be limited is by the cohort, he said.

“It’s very elderly men,” said Dr. Hotaling, who is not a study author.

The average age for men in the placebo group was 71.8 years and in the testosterone group, 71.4 years.

It’s also notable, according to Dr. Hotaling, that most of the men studied had other medical problems. According to the study, 60% of subjects were obese, about one-third had diabetes, and more than 70% had hypertension, among other comorbidities.

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“That begs the question, is it that the low testosterone level is causing all these other things, or is it because they’re not that healthy and that’s why they have low testosterone? Either way, putting them on testosterone made them feel better,” Dr. Hotaling said.

Next: How Dr. Hotaling will counsel patients

Based on the study’s findings, Dr. Hotaling said he will counsel his older male patients with low testosterone and sexual function concerns that the best data to date show testosterone therapy should improve their sexual function and, perhaps, their libido and erectile dysfunction.

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“The other thing that I would tell them… is that having low testosterone in that age group may be a marker-it may be associated with or a result of their having these other medical comorbidities,” he said. “The take-home would be that in addition to giving them this replacement, it’s very important to address those underlying things. And from a clinical standpoint, it’s important for urologists to understand that association status. It would be very interesting to repeat this study in 40-year-old men.”

The research was supported primarily by the National Institutes of Health. AbbVie provided funding, AndroGel, and placebo gel. Dr. Cunningham has served as a consultant to AbbVie, Apricus, Besins, Clarus Therapeutics, Endo Pharma, Ferring, Lilly, Pfizer, and Repros Therapeutics. Dr. Cunningham has also served as an expert witness for Repros Therapeutics, and Solvay. He has received research support from Ardana and Unimed. Several of his co-authors have disclosures with pharmaceutical companies.

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