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3 December 2014

Testosterone therapy in male sexual function

Testosterone therapy in male sexual function
Testosterone Therapy and Sexual Function: A Meta-Analysis Study
Corona G, Isidori A, Buvat J, et al. J Sex Med 2014;11:1577–92.

Male sexual dysfunction is a common occurrence in clinical practice, especially in hypogonadal patients, however it is often untreated or undiagnosed. This summary is based on a meta-analysis of 41 studies that compared testosterone therapy with placebo or as add-on therapy to phosphodiesterase type 5 inhibitors (PDE5i), and aimed to evaluate the role of testosterone therapy in male sexual function where previous meta-analyses have produced conflicting results. Based on an extensive search of the Medline, Embase, and Cochrane databases, 1,702 studies were identified and 41 met the criteria for this analysis.

Key Points

  • This meta-analysis (which included the largest number of studies so far) was performed to more clearly understand the effects of testosterone therapy on male sexual dysfunction, as prior meta-analyses have yielded conflicting results
  • 41 studies were included that compared the effects of testosterone therapy with placebo (29 studies), or testosterone therapy as add-on to PDE5i (12 studies) on male sexual function
  • Mean follow-up for studies analysing TS with placebo was 27 weeks. 5 trials evaluated testosterone therapy in eugonadal patients, 5 in a mixed population of hypogonadal/eugonadal patients, and 19 in hypogonadal patients
  • Compared with placebo, testosterone therapy significantly improved overall erectile function (EF) and improved other aspects of male sexual response
  • Testosterone therapy was not associated with any increase in cardiovascular diseases compared with placebo; whilst hematocrit levels increased, there was no increase in the risk of pathological hematocrit levels compared with placebo
  • Overall, the lower testosterone levels at baseline, the more pronounced the beneficial effect of testosterone therapy
  • In 894 patients who were treated with testosterone therapy as add-on to PDE5i (mean follow-up of 12 weeks), a positive effect of T was found in non-placebo-controlled trials (effect size 2.96 [95% CI, 1.28–4.64]) but not in placebo-controlled trials
  • Well-designed studies with large study populations (many of which are industry sponsored) are most likely to produce robust clinical data and are more likely to be published than smaller independent studies

11 November 2013

Testosterone undecanoate can improve sexual function and quality of life in males with type 2 diabetes

Image: Blood meter

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 G, Cole N, Bhartia M, et al. J Sex Med 2013; 10(6):1612-1617.

This editorial discusses the key findings and implications of a study published in 2013 by Hackett et al. (The BLAST study) that investigated the effect of testosterone replacement therapy on sexual function and quality of life parameters versus placebo in males with type 2 diabetes (T2D). The study was separated into two phases. The first phase was a 30-week, prospective, randomized, double-blind, placebo-controlled multicenter study conducted between September 2008 and June 2011 at eight UK Midland centers. A total of 190 males (age >18 years) with T2D received long-acting Testosterone Undecanoate (TU) 1000 mg or placebo for 30 weeks (at weeks 0, 6, and 18). The second phase was a 52-week follow-on with open-label TU therapy in 96 patients proceeding from the first phase. The primary outcome of the study was a statistically significant change from baseline in the 15-item International Index of Erectile Function (IIEF) domains. Notable secondary outcomes included health-related quality-of-life symptoms, as measured by the 17-item Ageing Male Symptom Scale (AMS) questionnaire.

Key Points

  • The 82-week BLAST study, which included 190 males age >18 years with T2D, is the largest and longest study to date that investigates the effects of TU therapy in males with T2D
  • In contrast with comparative studies, the study was performed by general practitioners in the primary care setting, rather than specialist diabetes centers
  • TU significantly improved all IIEF domains versus placebo at 30 weeks, with significant improvements also seen at 18 weeks

    • At 30 weeks, improvement with TU versus placebo included erectile function, p=0.005; intercourse satisfaction, p=0.015; sexual desire, p=0.001; orgasm, p=0.004
    • For erectile function, there were significant improvements at 18 and 30 weeks for TU versus placebo in males aged ≥60 years
  • Improvements in sexual function scores were seen as early as 6 weeks with TU versus placebo
  • Sexual function scores continued to improve in the open-label extension to the end of study (weeks 30 to 82)

    • An improvement from baseline in erectile function was observed for the active group continuing on TU therapy and the placebo group proceeding to TU therapy (4.31 and 2.97, respectively)
  • Health-related quality-of-life measures were significantly improved at 30 weeks for TU versus placebo in males without depression (p=0.02), but not in males with baseline depression
  • In a subgroup of males taking phosphodiesterase type 5 inhibitors, there was improvement in erectile function in the open-label phase only

21 August 2012

Retrospective observational study finds hypogonadism prevalent in men with sexual dysfunction and related to a range of chronic illnesses

Image: Senior person getting blood pressure examination by a cardiologist

Hypogonadism in men with erectile dysfunction may be related to a host of chronic illnesses. Guay A, Seftel AD, Traish A. Int J Impot Res 2010; 22(1):9-19 [Erratum in: Int J Impot Res 2010; 22(3):210].

This retrospective, observational study evaluated the prevalence of hypogonadism among men with sexual dysfunction, and examined its association with medical and psychological factors. The study involved 990 men (90% Caucasian) who attended an endocrinology specialist centre for sexual function as a new consultation between July 1995 and July 1997. To identify medical and psychological conditions, patients underwent a detailed clinical evaluation and their medical history was examined. A diagnosis of hypogonadism was made based on a total testosterone level of <300 ng/dL (<10.4 nmol/L) accompanied by three or more signs/symptoms of hypogonadism. Primary hypogonadism was identified when low testosterone levels were accompanied by normal levels of luteinizing hormone (≥9 IU/L). Associations between conditions (medical and psychological) and hypogonadism were examined using the Mantel−Haenszel-test.

The mean age of the men was 57.4 years and all had sexual dysfunction. Overall, 359 men (36.3%) had hypogonadism, most of whom were diagnosed with secondary hypogonadism (301 men). The men in this study had a high prevalence of chronic medical and/or psychological conditions, including; diabetes mellitus (23.1%), hypertension (35.8%), atherosclerotic coronary artery disease (19.9%), work-related stress (27.5%) and anxiety/depression (21.0%), and 28.2% of men were on multiple medications.

Key Points

  • The prevalence of hypogonadism among men with sexual dysfunction and common medical causes of ED ranged from 30.8−64.3%
  • Hypogonadism was prevalent among men who used alcohol excessively or who smoked
  • The prevalence of hypogonadism was also substantial among men receiving medication for anxiety or depression and in men with work-related stress
  • The highest prevalence of hypogonadism was observed in men in their 50’s and 60’s
  • A significant association between the medical or psychiatric causes of ED and hypogonadism was limited to hypertension, tobacco abuse, sleep apnea and work stress
  • Sleep apnea and work stress in particular were positively associated with hypogonadism.

1 September 2011

Endocrine aspects of the diagnosis and treatment of male sexual dysfunction: new ISSM Guidelines

Image: Endocrine aspects of the diagnosis and treatment of male sexual dysfunction

Endocrine aspects of male sexual dysfunctions. Buvat J, Maggi M, Gooren L, et al. J Sex Med 2010;7(4 Pt 2):1627-1656.

This article is a summary of the report by the Endocrine Aspects of Male Sexual Dysfunctions international experts Committee aimed to provide guidelines based on best evidence for the diagnosis and treatment of endocrine-related male sexual dysfunction. It was prepared in collaboration with the Standards Committee of the International Society of Sexual Medicine (ISSM) and presented at the Third International Consultation of Sexual Medicine (ICSM) in Paris in July 2009. The report was finalized following detailed review of the medical literature, extensive discussion over two years, and public presentation and discussion with other experts, and provides a standardized process for the diagnosis and treatment of endocrine-related male sexual dysfunction. A total of 30 evidence-based recommendations were made and the supporting evidence detailed, including updated knowledge on the prostate and cardiovascular safety of testosterone; key recommendations are presented in this article.

Key Points

Key evidence-based recommendations included:

  • Clinical and biochemical diagnosis
  • Testosterone (T) deficiency (TD) and metabolic diseases
  • T and cardiovascular (CV) diseases
  • T therapy and CV health
  • Questionnaires to screen for TD
  • Indications for T treatment
  • Age and T treatment
  • Indications for T treatment in men with sexual dysfunction
  • Combination therapy with T and phosphodiesterase type 5 inhibitors
  • Commercial T formulations
  • Serum T levels to be achieved with T treatment
  • Prostate safety
  • Cautions in the use of T therapy
  • Monitoring

28 June 2011

Testosterone undecanoate injection normalizes testosterone levels and improves sexual function in Korean men with hypogonadism and ED

Image: Senior couple

The efficacy and safety of testosterone undecanoate (Nebido®) in testosterone deficiency syndrome in Korean: a multicenter prospective study. Moon DG, Park MG, Lee SW, et al. J Sex Med 2010;7(6):2253-2260.

This prospective, multicentre study assessed the efficacy and safety of testosterone replacement therapy (TRT) with a long-acting intramuscular injection of testosterone undecanoate (Nebido®) in an Asian population.1 A total of 133 Korean patients (mean age 54, range 42–75 years) with erectile dysfunction (ED) and testosterone deficiency syndrome (serum testosterone <3.5 ng/mL [12 nmol/L]) were treated with testosterone undecanoate 1000 mg at baseline and again at 6 and 18 weeks. The primary efficacy endpoints were the changes in International Index of Erectile Function (IIEF) score from the initial visit to the final visit (24 weeks) and from the initial visit to each visit. Changes in the Aging Males' Symptoms (AMS) Scale and the Global Efficacy Question (GEQ) for improvement of erectile function were also evaluated.

Key Points


  • Testosterone replacement therapy (TRT) significantly increased serum total T and free T by week 12 in Korean men with ED and hypogonadism
  • TRT also significantly improved:

    • total IIEF score and all 5 domain scores
    • total AMS scale and all three domain scores of AMS
  • 77% of men reported improved erectile function
  • Improvements in lipid profile and some metabolic components were seen
  • Serum glucose levels tended to improve with treatment, reaching statistical significance in men with elevated initial glucose levels
  • TRT was effective, safe and well tolerated in hypogonadal Asian men.


1 April 2011

Men with erectile dysfunction and low testosterone levels have an increased risk of dying from cardiovascular disease

Image: Human heart

Citation: Low testosterone is associated with an increased risk of MACE lethality in subjects with erectile dysfunction. Corona G, Monami M, Boddi V, et al. J Sex Med 2010;7(4 Pt 1):1557-1564.

A consecutive series of 1687 patients attending an andrology clinic for erectile dysfunction (ED) was followed for a mean of 4.3 ± 2.6 years to investigate whether low testosterone levels predict incident fatal or nonfatal major adverse cardiovascular events (MACE) in men with ED. Patients in this prospective cohort study were interviewed using the structured interview on erectile dysfunction (SIEDY) and the ANDROTEST structured interview to measure aspects of ED and hypogonadal-related symptoms. Total testosterone was evaluated at baseline and information on MACE was obtained from registry database records.

Key Points

The nested case-control study showed:

  • At baseline, over 20% of men were hypogonadal, according to a widely accepted lower limit for normal total testosterone levels
  • Hypogonadism ranged from 5.2% to 13.8% and 22.4% depending on the threshold used (total testosterone less than 8, 10.4 and 12 nmol/L, respectively
  • During follow-up, 139 of the patients had a major cardiac event, such as ischaemic heart disease, cerebrovascular events (stroke or transient ischaemic attack) or peripheral artery disease
  • MACE were fatal in 15 men
  • Although low testosterone in itself was not associated with MACE, those patients with total testosterone levels below 10.4 nmol/L who had a major cardiac event were significantly more likely to die than those with higher testosterone levels
  • When adjusted for Chronic Diseases Score (an index of comorbidities) the risk of death was increased by a factor of seven (hazard ratio [HR] 7.1) in men with testosterone below 8 nmol/L
  • Of interest, fatal MACE were associated with a higher ANDROTEST score measuring hypogonadal-related symptoms and signs (HR = 1.2 for each ANDROTEST score increment; P = 0.05).
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Last updated: 2019