Older men with low testosterone levels and low sex drive who used a testosterone gel were more likely to show interest in sex, and to have sex more often, than those on placebo in a randomized trial.
Researchers took 470 men, all ages 65 or older with testosterone levels below 275 ng/dL (mean 234 ng/dL, SD 63), and randomized them to receive either AndroGel or placebo gel for 1 year as part of the Testosterone Trials (TTrials); those using the testosterone gel reported significant improvements on 10 of 12 measures of sexual activity, such as how often they had intercourse and whether they anticipated sex.
In addition, increases in total and free testosterone was associated with improvements in sexual activities, but not erectile function, and there was no threshold effect seen for any of the outcomes measured, according to the investigators, who were led by Glenn Cunningham, MD, at the Baylor College of Medicine in Houston.
Cunningham and colleagues published their findings on Wednesday in the Journal of Clinical Endocrinology & Metabolism.
“To date, the sexual function trial of the TTrials is the largest placebo-controlled trial of the efficacy of testosterone on sexual function in older men with low libido and unequivocally low testosterone levels,” wrote the authors.
Most previous research has been of small groups, and only a few trials have included men with sexual symptoms, according to the authors, with some of those trials selecting men without any inclusion criteria for specific symptoms. Previous studies have generated conflicting results, and the TTrials comprise seven randomized trials to see how older men with low testosterone and symptoms respond.
AndroGel is currently approved for treating primary hypogonadism, on the basis of earlier studies involving men with serum testosterone levels below 300 ng/dL, but the product’s label indicates that “safety and efficacy … in men with ‘age-related hypogonadism’ have not been established.” The current study was funded by AndroGel’s manufacturer, AbbVie.
Cunningham and colleagues assessed sexual function at 3, 6, 9, and 12 months using 12 questions from an item on the PDQ survey. The survey asked about masturbation, having sexual daydreams, and other items like getting erections, ejaculating, and having orgasms. No significant improvements were seen in two of the measures: being flirted with by others and getting spontaneous erections during the day.
Patients were about 71 years old on average, and there were significantly more Hispanic patients and more married men in the treatment group than in the placebo group, which the authors said was was possibly due to chance despite P values of 0.02. Over 60% of the men in the study were obese, and about 33% had diabetes.
Of 27 baseline characteristics tested for, only alcohol use was related to post-treatment sexual activity and desire, as those in the treatment group who had more drinks saw a greater increase in sexual desire.
Patients started on a dose of 5 g each day with a target serum testosterone concentration range of 400-800 ng/dL that was later changed to 500-800 ng/dL after the early trial data showed that the median testosterone concentration of the men assigned to the treatment arm was 400-500 ng/dL, which was below the middle of the target range. Researchers tested compliance by weighing the patients’ pump bottles.
In some studies evaluating sexual function, depression can affect the outcomes, according to the authors, but the depression scores in this study were low and the treatment and control groups were balanced by randomization.
The findings might not be generalizable since the patients were required to be in a stable relationship with a partner, and the design of the study didn’t allow the authors to determine whether estradiol — which usually increases with testosterone treatment — had an independent effect on sexual function.
The study was funded by AbbVie (Androgel’s manufacturer) and by grants from the federal government.
The authors disclosed relationships with AbbVie, Apricus, Besins, Clarus Therapeutics, Endo Pharma, Ferring, Lilly, Pfizer, Repros Therapeutics, Ardana, Unimed, Sanofi, and Novartis, among others.
last updated 06.30.2016
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