Testosterone undecanoate is associated with improved ageing male symptoms score in men with type 2 diabetes and adult-onset testosterone deficiency: re-analyzed results from a randomised controlled trial

Pravinath Ramachandran; Michael Zitzmann; Carola S. König; Joseph Mulhern; Sudarshan Ramachandran; Geoff Hackett

doi:10.37349/eemd.2024.00015

Testosterone undecanoate is associated with improved ageing male symptoms score in men with type 2 diabetes and adult-onset testosterone deficiency: re-analyzed results from a randomised controlled trial

Pravinath Ramachandran
, Michael Zitzmann
, Carola S. König
, Joseph Mulhern
, Sudarshan Ramachandran
, Geoff Hackett

Aston Medical School

College of Psychology, Birmingham City University, B4 7BD Birmingham, United Kingdom
Department of Clinical and Surgical Andrology, Centre of Reproductive Medicine and Andrology, Münster University Hospital, 48149 Münster, Germany
Centre of Advanced powertrain and fuels, Department of Mechanical, Aerospace, & Civil Engineering, Brunel University London, Uxbridge, UB8 3PH, London, United Kingdom
Department of Clinical Biochemistry, University Hospitals Birmingham NHS Foundation Trust, B75 7RR West Midlands, United Kingdom
Department of Mechanical and Aerospace Engineering, Brunel University London, UB8 3PH London, United Kingdom; Department of Clinical Biochemistry, University Hospitals Birmingham NHS Foundation Trust, B75 7RR West Midlands, United Kingdom; Department of Clinical Biochemistry, University Hospitals of North Midlands, ST4 6QG Staffordshire, United Kingdom; School of Pharmacy and Bioengineering, Keele University, ST5 5BG Staffordshire, United Kingdom

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Abstract

Aim: To evaluate changes in quality of life via the ageing male symptom scale (AMSS) and somatic, psychological, and sexual sub-scales following testosterone undecanoate (TU) or placebo (P) treatment in men with type 2 diabetes mellitus (T2DM) and adult-onset testosterone deficiency (TD) via a re-analysis of the BLAST (Burntwood, Lichfield, Atherstone, Sutton Coldfield, and Tamworth) randomised controlled trial (RCT). Methods: Analysis of data from the BLAST RCT in men with T2DM and adult-onset TD was performed. Summation baseline and study-end AMSS data were available in 170 men (94: P; 76: TU) with subscale data available in 82 men. Rank-sum and sign-rank tests determined inter/intra-group differences, whilst linear/multiple regression models identified predictors of AMSS change. Results: AMSS improved significantly in P [–2 (median), p = 0.010] and TU [–6 (median), p < 0.0001)] arms, with greater improvement observed in men on TU (p = 0.014). No significant change was seen in either arm with baseline AMSS < 27 (asymptomatic). TU was significantly associated with AMSS improvement in all symptomatic AMSS categories. Improvement in the P arm was confined to men with baseline AMSS > 49. In the cohort with subscale AMSS data, TU was associated with improvements in somatic, psychological, and sexual subscales, whilst improvement was limited to the somatic subscale in the men on P. TU (reference: P) and higher baseline AMSS were significantly and independently associated with AMSS improvement. The improvement in summation AMSS associated with TU (reference: P) was only evident in men with mild depression and no anxiety (based on baseline Hospital Anxiety and Depression Scale data). Conclusions: TU appeared associated with improved AMSS (summation and subscales) in men with T2DM and adult-onset TD demonstrating symptoms (AMSS ≥ 27) with this benefit mediated by levels of depression and anxiety (European Union Clinical Trials Register, EudraCT 2008-000931-16).

Original language	English
Pages (from-to)	177-190
Number of pages	14
Journal	Exploration of Endocrine and Metabolic Diseases
Early online date	13 Aug 2024
DOIs	https://doi.org/10.37349/eemd.2024.00015
Publication status	E-pub ahead of print - 13 Aug 2024

Bibliographical note

© The Author(s) 2024. This is an Open Access article licensed under a Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, sharing, adaptation, distribution and reproduction in any medium or format, for any purpose, even commercially, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

Data Access Statement

The datasets that support the findings of this study are available from Professor Sudarshan Ramachandran upon reasonable request.

Funding

The practice expenses (BLAST RCT) of the research are supported by a grant from Bayer plc [BSP-SOP- 040]. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The authors did not receive any support from any organization for the submitted work. No funding was received to assist with the preparation of this manuscript

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Ageing male symptoms score
hhospital anxiety and depression scale
testosterone therapy
type 2 diabetes
adult-onset hypogonadism

Access to Document

10.37349/eemd.2024.00015

Testosterone undecanoate is associated with improved ageing male symptoms score in men with type 2 diabetes and adult-onset testosterone deficiency
© The Author(s) 2024. This is an Open Access article licensed under a Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, sharing, adaptation, distribution and reproduction in any medium or format, for any purpose, even commercially, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
Final published version, 1.78 MBLicence: CC BY 4.0

Cite this

Ramachandran, P., Zitzmann, M., König, C. S., Mulhern, J., Ramachandran, S., & Hackett, G. (2024). Testosterone undecanoate is associated with improved ageing male symptoms score in men with type 2 diabetes and adult-onset testosterone deficiency: re-analyzed results from a randomised controlled trial. Exploration of Endocrine and Metabolic Diseases, 177-190. Advance online publication. https://doi.org/10.37349/eemd.2024.00015

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title = "Testosterone undecanoate is associated with improved ageing male symptoms score in men with type 2 diabetes and adult-onset testosterone deficiency: re-analyzed results from a randomised controlled trial",

abstract = "Aim: To evaluate changes in quality of life via the ageing male symptom scale (AMSS) and somatic, psychological, and sexual sub-scales following testosterone undecanoate (TU) or placebo (P) treatment in men with type 2 diabetes mellitus (T2DM) and adult-onset testosterone deficiency (TD) via a re-analysis of the BLAST (Burntwood, Lichfield, Atherstone, Sutton Coldfield, and Tamworth) randomised controlled trial (RCT). Methods: Analysis of data from the BLAST RCT in men with T2DM and adult-onset TD was performed. Summation baseline and study-end AMSS data were available in 170 men (94: P; 76: TU) with subscale data available in 82 men. Rank-sum and sign-rank tests determined inter/intra-group differences, whilst linear/multiple regression models identified predictors of AMSS change. Results: AMSS improved significantly in P [–2 (median), p = 0.010] and TU [–6 (median), p < 0.0001)] arms, with greater improvement observed in men on TU (p = 0.014). No significant change was seen in either arm with baseline AMSS < 27 (asymptomatic). TU was significantly associated with AMSS improvement in all symptomatic AMSS categories. Improvement in the P arm was confined to men with baseline AMSS > 49. In the cohort with subscale AMSS data, TU was associated with improvements in somatic, psychological, and sexual subscales, whilst improvement was limited to the somatic subscale in the men on P. TU (reference: P) and higher baseline AMSS were significantly and independently associated with AMSS improvement. The improvement in summation AMSS associated with TU (reference: P) was only evident in men with mild depression and no anxiety (based on baseline Hospital Anxiety and Depression Scale data). Conclusions: TU appeared associated with improved AMSS (summation and subscales) in men with T2DM and adult-onset TD demonstrating symptoms (AMSS ≥ 27) with this benefit mediated by levels of depression and anxiety (European Union Clinical Trials Register, EudraCT 2008-000931-16).",

keywords = "Ageing male symptoms score, hhospital anxiety and depression scale, testosterone therapy, type 2 diabetes, adult-onset hypogonadism",

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note = "{\textcopyright} The Author(s) 2024. This is an Open Access article licensed under a Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, sharing, adaptation, distribution and reproduction in any medium or format, for any purpose, even commercially, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. ",

year = "2024",

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Ramachandran, P, Zitzmann, M, König, CS, Mulhern, J, Ramachandran, S & Hackett, G 2024, 'Testosterone undecanoate is associated with improved ageing male symptoms score in men with type 2 diabetes and adult-onset testosterone deficiency: re-analyzed results from a randomised controlled trial', Exploration of Endocrine and Metabolic Diseases, pp. 177-190. https://doi.org/10.37349/eemd.2024.00015

Testosterone undecanoate is associated with improved ageing male symptoms score in men with type 2 diabetes and adult-onset testosterone deficiency: re-analyzed results from a randomised controlled trial. / Ramachandran, Pravinath; Zitzmann, Michael; König, Carola S. et al.
In: Exploration of Endocrine and Metabolic Diseases, 13.08.2024, p. 177-190.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Testosterone undecanoate is associated with improved ageing male symptoms score in men with type 2 diabetes and adult-onset testosterone deficiency: re-analyzed results from a randomised controlled trial

AU - Ramachandran, Pravinath

AU - Zitzmann, Michael

AU - König, Carola S.

AU - Mulhern, Joseph

AU - Ramachandran, Sudarshan

AU - Hackett, Geoff

N1 - © The Author(s) 2024. This is an Open Access article licensed under a Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, sharing, adaptation, distribution and reproduction in any medium or format, for any purpose, even commercially, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

PY - 2024/8/13

Y1 - 2024/8/13

N2 - Aim: To evaluate changes in quality of life via the ageing male symptom scale (AMSS) and somatic, psychological, and sexual sub-scales following testosterone undecanoate (TU) or placebo (P) treatment in men with type 2 diabetes mellitus (T2DM) and adult-onset testosterone deficiency (TD) via a re-analysis of the BLAST (Burntwood, Lichfield, Atherstone, Sutton Coldfield, and Tamworth) randomised controlled trial (RCT). Methods: Analysis of data from the BLAST RCT in men with T2DM and adult-onset TD was performed. Summation baseline and study-end AMSS data were available in 170 men (94: P; 76: TU) with subscale data available in 82 men. Rank-sum and sign-rank tests determined inter/intra-group differences, whilst linear/multiple regression models identified predictors of AMSS change. Results: AMSS improved significantly in P [–2 (median), p = 0.010] and TU [–6 (median), p < 0.0001)] arms, with greater improvement observed in men on TU (p = 0.014). No significant change was seen in either arm with baseline AMSS < 27 (asymptomatic). TU was significantly associated with AMSS improvement in all symptomatic AMSS categories. Improvement in the P arm was confined to men with baseline AMSS > 49. In the cohort with subscale AMSS data, TU was associated with improvements in somatic, psychological, and sexual subscales, whilst improvement was limited to the somatic subscale in the men on P. TU (reference: P) and higher baseline AMSS were significantly and independently associated with AMSS improvement. The improvement in summation AMSS associated with TU (reference: P) was only evident in men with mild depression and no anxiety (based on baseline Hospital Anxiety and Depression Scale data). Conclusions: TU appeared associated with improved AMSS (summation and subscales) in men with T2DM and adult-onset TD demonstrating symptoms (AMSS ≥ 27) with this benefit mediated by levels of depression and anxiety (European Union Clinical Trials Register, EudraCT 2008-000931-16).

AB - Aim: To evaluate changes in quality of life via the ageing male symptom scale (AMSS) and somatic, psychological, and sexual sub-scales following testosterone undecanoate (TU) or placebo (P) treatment in men with type 2 diabetes mellitus (T2DM) and adult-onset testosterone deficiency (TD) via a re-analysis of the BLAST (Burntwood, Lichfield, Atherstone, Sutton Coldfield, and Tamworth) randomised controlled trial (RCT). Methods: Analysis of data from the BLAST RCT in men with T2DM and adult-onset TD was performed. Summation baseline and study-end AMSS data were available in 170 men (94: P; 76: TU) with subscale data available in 82 men. Rank-sum and sign-rank tests determined inter/intra-group differences, whilst linear/multiple regression models identified predictors of AMSS change. Results: AMSS improved significantly in P [–2 (median), p = 0.010] and TU [–6 (median), p < 0.0001)] arms, with greater improvement observed in men on TU (p = 0.014). No significant change was seen in either arm with baseline AMSS < 27 (asymptomatic). TU was significantly associated with AMSS improvement in all symptomatic AMSS categories. Improvement in the P arm was confined to men with baseline AMSS > 49. In the cohort with subscale AMSS data, TU was associated with improvements in somatic, psychological, and sexual subscales, whilst improvement was limited to the somatic subscale in the men on P. TU (reference: P) and higher baseline AMSS were significantly and independently associated with AMSS improvement. The improvement in summation AMSS associated with TU (reference: P) was only evident in men with mild depression and no anxiety (based on baseline Hospital Anxiety and Depression Scale data). Conclusions: TU appeared associated with improved AMSS (summation and subscales) in men with T2DM and adult-onset TD demonstrating symptoms (AMSS ≥ 27) with this benefit mediated by levels of depression and anxiety (European Union Clinical Trials Register, EudraCT 2008-000931-16).

KW - Ageing male symptoms score

KW - hhospital anxiety and depression scale

KW - testosterone therapy

KW - type 2 diabetes

KW - adult-onset hypogonadism

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U2 - 10.37349/eemd.2024.00015

DO - 10.37349/eemd.2024.00015

M3 - Article

SP - 177

EP - 190

JO - Exploration of Endocrine and Metabolic Diseases

JF - Exploration of Endocrine and Metabolic Diseases

ER -

Ramachandran P, Zitzmann M, König CS, Mulhern J, Ramachandran S, Hackett G. Testosterone undecanoate is associated with improved ageing male symptoms score in men with type 2 diabetes and adult-onset testosterone deficiency: re-analyzed results from a randomised controlled trial. Exploration of Endocrine and Metabolic Diseases. 2024 Aug 13;177-190. Epub 2024 Aug 13. doi: 10.37349/eemd.2024.00015

Testosterone undecanoate is associated with improved ageing male symptoms score in men with type 2 diabetes and adult-onset testosterone deficiency: re-analyzed results from a randomised controlled trial

Abstract

Bibliographical note

Data Access Statement

Funding

UN SDGs

Keywords

Access to Document

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Cite this