CoChat
Sign Up
Cited by 182Hormonal and reproductive studiesSexual function and dysfunction studiesAdrenal Hormones and Disorders

Testosterone Replacement Therapy with Long‒Acting Testosterone Undecanoate Improves Sexual Function and Quality‒of‒Life Parameters vs. Placebo in a Population of Men with Type 2 Diabetes

Hackett, Geoffrey, Cole, Nigel, Bhartia, Mithun, Kennedy, David, Raju, Jessie, Wilkinson, Peter·2013·The Journal of Sexual Medicine
DOI 10.1111/jsm.12146
Open this paper in CoChat — free account

Abstract

Introduction: Sexual dysfunction, particularly erectile dysfunction (ED), is common in men with type 2 diabetes, occurring in up to 75% of cases. The prevalence of hypogonadism is also high in men with diabetes and low testosterone is associated with both sexual dysfunction and a reduced response to oral therapy for ED. Aim: This study aimed to determine the effect of testosterone replacement with long‒acting Testosterone Undecanoate (TU) on sexual function, mood and quality of life vs. placebo over a treatment period of 30 weeks followed by 52 weeks of open‒label medication. The study was conducted in a primary care population of men with type 2 diabetes attending their primary care physician for routine visits. Methods: The male diabetic populations of seven general practices were screened at routine diabetes visits to detect symptomatic men with total testosterone levels of 12 nmol/L or less or with free testosterones of 250 pmol/L or less. Two hundred eleven men were screened. A double‒blind placebo‒controlled study was conducted in 199 men with type 2 diabetes and hypogonadism treated for 30 weeks with either 1,000 mg of TU or matching placebo followed by 52‒week open‒label follow on. Main Outcome Measures: The primary outcome measure, International Index of Erectile Function (IIEF), was used to evaluate sexual dysfunction, and the Ageing Male Symptom (AMS), Hospital Anxiety and Depression Scale, and Global Efficacy Question were used as secondary outcome measures to assess mood and self‒reported quality of life. Results: Testosterone replacement therapy with long‒acting TU improved all domains of sexual function at 30 weeks (erectile function [EF], P = 0.005; intercourse satisfaction, P = 0.015; sexual desire, P = 0.001; overall satisfaction, P = 0.05; and orgasm, P = 0.04), with benefit as early as 6 weeks. Improvements in AMS score were significant in men without depression (P = 0.02) and the presence of depression at baseline was associated with marked reduction in response to both sexual function and psychological scores. All responses in sexual function continued to improve significantly up to 18 months with an improvement in EF score of 4.31 from baseline. In a small cohort of 35 men taking phosphodiesterase type 5 inhibitors, there was no change during the double‒blind phase but a nine‒point improvement in EF domain during 52‒week open‒label treatment. After 30 weeks, 46% vs. 17% of patients on active therapy vs. placebo felt that the treatment had improved their health, reaching 70% after open‒label therapy. Less obese and older patients responded better to testosterone therapy. There were no significant adverse events. Conclusion: TU significantly improved all domains of the IIEF and patient reported quality of life at 30 weeks and more significantly after 52‒week open‒label extension. Improvement was most marked in less obese patient and those without coexisting depression. In men with type 2 diabetes, trials of therapy may need to be given for much longer than 3–6 months suggested in current guidelines.

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1111/jsm.12146

Cites

54 of 54 references verified0 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Cites

Flagged first, then by citations

Cited by

Sorted by citations

Related

Authors
Hackett, G., Cole, N., Bhartia, M., Kennedy, D., Raju, J., & Wilkinson, P.
Affiliations
  • Good Hope Hospital (GB)
  • Cloisters Practice , Lichfield , UK
  • Wilkinson Associates , Radnor, Herts , UK
Corresponding author
Hackett, Geoffrey
ORCID
Hackett, Geoffrey
Venue
The Journal of Sexual Medicine
Publisher
Oxford University Press (OUP)
Published
2013-06-01
Volume
10
Issue
6
Pages
1612-1627
ISSN
  • 1743-6095 (ISSN-L)
  • 1743-6109
DOI
10.1111/jsm.12146
OpenAlex
W1607566717
Cited by
182
References
54
Citations by year
2026: 4 · 2025: 7 · 2024: 12 · 2023: 3 · 2022: 10 · 2021: 4 · 2020: 13 · 2019: 11 · 2018: 13 · 2017: 14 · 2016: 26 · 2015: 21 · 2014: 33 · 2013: 10
FWCI
23.58
Type
journal article
Language
en
Open access
closed
Licence
academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
Locations
  • The Journal of Sexual Medicine (publishedVersion)
  • PubMed (publishedVersion)
Funders
Eli Lilly and Company
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
  • Health Sciences › Medicine › Psychiatry and Mental health › Sexual function and dysfunction studies
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
Keywords
testosterone undecanoate, type 2 diabetes, hypogonadism, erectile dysfunction, sexual function, quality of life, mood, depression, anxiety, phosphodiesterase-5 inhibitors, International Index of Erectile Function, primary care, open-label extension, sexual desire
MeSH terms
Adult, Affect, Aged, Aged, 80 and over, Depression, Diabetes Mellitus, Type 2, Double-Blind Method, England, Humans, Hypogonadism, Erectile Dysfunction, Male, Middle Aged, Penile Erection, Prospective Studies, Quality of Life, Surveys and Questionnaires, Sexual Behavior, Testosterone, Treatment Outcome, Patient Satisfaction, Hormone Replacement Therapy, Phosphodiesterase 5 Inhibitors

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review