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Testosterone Undecanoate improves Sexual Function in Men with Type 2 diabetes and Severe Hypogonadism: Results from a 30 week randomized placebo controlled study.


OBJECTIVE: To evaluate the Sexual Function response to 30 weeks treatment with Long Acting Testosterone Undecanoate (TU) or Placebo (P) 199 men with type 2 diabetes and either severe or mild hypogonadism. PATIENTS AND METHODS: Men with hypogonadism (HG) were identified from 7 primary care T2DM registers. A 30 week randomised placebo controlled study of TU was carried out in 199 of these men (P: 107, TU: 92). The patient reported outcome measure was the IIEF -15. Men completing the study (n=189) were stratified firstly, by baseline total testosterone (TT) / free testosterone (FT) into Mild HG (TT 8.1-12nmol/l or FT 0.18-0.25nmol/l) and Severe HG groups (TT =8nmol/l and FT =0.18nmol/l) and secondly by intervention (P and TU) leading to 4 groups; Mild HG/P, Mild HG/TU, Severe HG/P and Severe HG/TU. STATISTICAL ANALYSIS: Changes in sexual function score (a secondary outcome of the study) at each visit within group (cf. baseline) and between groups (TU vs P) at each assessment (6, 18 and 30 weeks) were compared using Wilcoxon signed-rank and Wilcoxon rank sum tests respectively. RESULTS: Significant improvement in erectile function was evident only in the Severe HG group following TU after 30 weeks, this finding also present when TU was compared to P. Intercourse satisfaction and sexual desire scores were also improved in the Severe HG group following TU at 6, 18 and 30 weeks, this increase in scores also evident when compared to P. TU did not appear to significantly alter orgasmic function in any of the patient groups. CONCLUSIONS: Our study suggests that benefit in sexual symptoms following TU was evident principally in patients with HG with TT =8nmol/l and FT =0.18nmol/l. We also suggest 30 weeks of treatment is necessary before evaluating improvement in erectile function. This article is protected by copyright. All rights reserved.

Acceptance Date Apr 28, 2016
Publication Date May 27, 2016
Journal BJU Int
Print ISSN 1464-4096
Publisher Wiley
Pages 804-813
Keywords total testosterone; testosterone deficiency syndrome; testosterone replacement therapy; erectile dysfunction; sexual dysfunction; type 2 diabetes
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