Endocrine Abstracts

The objective of the study was to assess the effect of intra-muscular testosterone on constitutional symptoms, sexual symptoms, memory and in men with hypogonadism and poorly-controlled type-2 diabetes. This is a randomised double-blinded placebo-controlled add-on trial of intramuscular testosterone undecanoate(Nebido^®) administered every 12 weeks in 65 hypogonadal men with poorly-controlled diabetes. Phase-1 patients were randomly assigned to either treatment or placebo arm for 6 months of TRT. Phase-2 was an open-labelled phase for 6 months and patients on placebo moved on to the treatment group wherein patients in the treatment group continued. Outcomes(AMS, SF-36, IIEF-5 questionnaires, MMSE, Barnsley and NERI questionnaires) were assessed at baseline and every 3 months. Mean age of the cohort was 59±8.98 years(mean±SD). Baseline characteristics were comparable between active/placebo groups. Our study is the first ever RCT to show a significant reduction in the mean total AMS score from baseline of 48.34±13.13 to score of 37.72±12.25 at 6 months after testosterone treatment vs from 48.34±12.69 to score of 42.78±13.48 in the placebo group(P<0.05) in a cohort with type 2 diabetes and hypogonadism. Our study also showed that the proportion of patients with severe symptoms moving to a less severe category(low/mild/moderate severity) was 46% in the active vs only 28% in placebo group(P=0.0024). There was no significant difference in either the SF-36 scores, MMSE scores, BDHQ, NERI or IIEF scores or its domains at baseline and after 6 months of TRT. In phase-2 of the trial, there was a statistically significant reduction in the AMS total score all its subscales before and after TRT in the active arm at 12 months. A significant improvement in libido was also demonstrated. There was a significant reduction in the BDHQ total score(P=0.07) and two of its sub-domains − Sexual-wellbeing and Emotional-wellbeing(P=0.002 andP=0.011 respectively) within the active arm before and after treatment of testosterone at baseline(0), 3,6,9 and 12 months post treatment. There was significant improvement in the mean scores of physical health domain and health change in over 1-year domain of SF-36 questionnaire(P=0.019, P=0.019 respectively) and significant improvement in the mean scores of delayed verbal recall domain of MMSE which was highly significant(P=0.0004) before and after treatment in the active arm at baseline(0), 3,6,9 and 12 months post treatment. Our trial is the first RCT to show a significant improvement in constitutional symptoms, sexual symptoms, libido, symptom severity, and delayed verbal recall with TRT in a cohort with poorly-controlled type-2 diabetes and hypogonadism