Endocrine Abstracts

Introduction: Hypogonadal men frequently suffer from fatigue and reduced sexual function. International guidelines recommend testosterone replacement therapy (TRT) for symptomatic hypogonadal men. Our aim was to document testosterone changes and the impact of TRT with TESTIM on quality of life in routine daily practice.

Methods: In this non-interventional-study (NIS) data from 117 hypogonadal patients from 43 office-based-study-sites were evaluated. Data were collected at baseline, 3 and 6 months of TRT. Laboratory values, BMI and relevant clinical symptoms (loss of libido, obesity, erectile dysfunction and others; scale 0–4) were recorded. Patients were asked to fill in quality of life questionnaires: aging males symptoms scale (AMS), multidimensional fatigue inventory (MFI) and international index of erectile function (IIEF-5). Common pharmacovigilance monitoring was conducted.

Results: Testosterone increased significantly within 6 months from a median of 2.38 to 4.99 ng/ml. All recorded clinical symptoms improved significantly under TESTIM therapy. The most prominent clinical symptoms at baseline improved by 1.23, 1.53 and 0.78 points for erectile dysfunction, loss of libido and obesity respectively (P<0.0001).

Quality of life (AMS, MFI and IIEF-5) improved significantly under TESTIM therapy by 32.4, 28.6 and 48.3%, respectively (P<0.0001). We found significant associations of higher testosterone levels with freedom of symptoms from hypogonadism in AMS and IIEF-5 after 6 months of therapy (rs=0.279, P=0.0045).

Frequency of adverse events was 5.1%, with only 1.7% attributed to therapy. The most frequent adverse event was nausea (1.7%).

Conclusion: This NIS in hypogonadal men substantiates the clinical efficacy of TESTIM. Overall quality of life as well as sexual function improved significantly within 6 months of therapy, and fatigue was significantly reduced. A good or excellent efficacy and safety was demonstrated in the vast majority of patients in routine daily practice.

Declaration of interest: I fully declare a conflict of interest. Details below:

Funding: This work was supported, however funding details unavailable.