Endocrine Abstracts

Aims: Testosterone therapy (TTh) has been postulated to increase the risk of prostate adverse events (PAEs) and erythrocytosis, risk further exacerbated in high-risk obese patients with type 2 diabetes (T2D) and functional hypogonadism (FH). We investigated safety aspects of TTh in obese males with FH and T2D by observing the incidence of PAEs and erythrocytosis and determining when statistically significant difference from the baseline manifests in hematocrit (Hct) and prostate-specific antigen (PSA) levels.

Materials and Methods: Fifty-five obese men with FH and T2D participated in a two-part, prospective observational clinical study (first year: double-blind, randomized, placebo-controlled trial employing testosterone undecanoate; second year: open-label follow-up with all participants receiving TTh). Outcomes were assessments of Hct and PSA levels at the baseline, and 3, 6 and 12 months into each of two years of the study.

Results: No adverse cardiovascular events or PAEs were observed. Hct first increased at statistically significant level from the baseline after 3 months of TTh in group T and after 6 months of TTh in group P. Individual Hct values for all participants remained below 0.52 throughout 2-year course of the study. PSA increased from the baseline in both groups within 3-6 months of trial start regardless of intervention applied (placebo or TTh). 52 patients never exceeded PSA level of 4.0 μg/l nor experienced year-on-year PSA increase > 1.4 μg/l. No subject ever reached supraphysiological concentration of total testosterone.

Conclusions: Our results show that TTh may be safe in obese males with FH and T2D.