The effect of testosterone on mood and well-being in men with erectile dysfunction in a randomized, placebo-controlled trial

Abstract

The relationship between testosterone, well-being and mood is poorly understood. We investigated the effect of testosterone supplementation on mood, well-being, and self-reported health in men with erectile dysfunction (ED) and low serum testosterone levels. This was a randomized, double-blind, placebo-controlled trial (ClinicalTrials.gov registration number NCT00512707), in which 140 men, 40-70 years, with ED and low serum testosterone levels were first optimized on sildenafil alone for 3-7 weeks and then randomized to receive either sildenafil plus testosterone gel (n = 70) or sildenafil plus placebo (n = 70) gel for 14 weeks. Using multiple imputations and generalized linear regression, we compared psychological changes in well-being, evaluated by the Psychological General Well-Being Index, and mood, evaluated by Derogatis Affects Balance Scale. Mood and well-being scores were similar between the two groups at baseline and did not substantially change during the administration of sildenafil or after randomization to testosterone. Our findings show that the addition of testosterone to sildenafil in men with ED and low serum testosterone levels was not associated with improvement in either well-being or mood.

© 2013 American Society of Andrology and European Academy of Andrology.

Figures

Figure 1. Change in Psychological General Well-Being Index Scores with Sildenafil and Testosterone or Sildenafil and Placebo

CI = Confidence Interval Figure 1 displays observed (non-imputed) means and 95% confidence intervals for Psychological General Well-Being Index positive well-being, depressed mood, general health, anxiety, self-control, and global score at baseline, after being optimized on sildenafil citrate (randomization), and during weeks 8 and 14 after randomization to combination sildenafil and testosterone or sildenafil and placebo. These data have been normalized to a 100% scale to facilitate comparison. Tables report the number of participants included at each data point among the testosterone and placebo groups. Multiple imputed estimates of the differences in score changes over 14 weeks between testosterone and placebo groups with 95% confidence intervals are shown for domain and global scores. Higher scores in each scale correspond with greater well-being.

Figure 2. Change in Derogatis Affects Balance Scale Scores with Sildenafil and Testosterone or Sildenafil and Placebo

CI = Confidence Interval Figure 2 displays observed (non-imputed) means and 95% confidence intervals for Derogatis Affects Balance Scale mean affect scores at baseline, after being optimized on sildenafil citrate (randomization), and during weeks 8 and 14 after randomization to combination sildenafil and testosterone or sildenafil and placebo. Tables report the number of participants included at each data point among the testosterone and placebo groups. Affect scores may range from 0 to 20, and higher scores correspond with increased affectivity. Multiple imputed estimates of the differences in score changes over 14 weeks between testosterone and placebo groups with 95% confidence intervals are shown for each domain.

Figure 3. Baseline Serum Total Testosterone Levels Among Men Receiving Testosterone Does Not Predict Change in Well-being or Vigor

PWB = Positive Well-being; CI = Confidence Interval A scatter plot displays the relationship between observed (non-imputed) baseline serum total testosterone levels and on-treatment changes in Psychological General Well-Being Index positive well-being domains over 14 weeks among men randomized to testosterone therapy on the left (n = 60). The relationship between observed baseline serum total testosterone and change in Derogatis Affects Balance Scale Vigor domain among men receiving testosterone therapy is displayed on the right (n = 57). Regression lines with 95% confidence intervals overlay the data, and the equations for these lines are printed at the bottom of each plot.