Testosterone Research News for Healthcare Professionals

Rational approach to categorizing testosterone levels using community-based reference ranges

menshealthcare@bayerhealthcare.com — Wed, 02 May 2012 09:00:00 +0100

This study generated reference limits for total and free testosterone levels in a community-based sample of nonobese healthy young (19-40 years) men enrolled in the Framingham Heart Study third generation cohort. These reference limits were then applied to three geographically distinct cohorts of community dwelling men drawn from the Framingham Heart Study (FHS) generations 2 and 3, the European Male Aging Study (EMAS) and the Osteoporotic Fractures in Men Study (MrOS). A ‘gold standard’ assay method, liquid chromatography tandem mass spectrometry (LC-MS/MS) was used throughout to determine total testosterone levels; free testosterone levels were calculated using a published law-of-mass-action equation.
Researchers then investigated whether men deemed to have low total and free testosterone levels by the proposed reference limits had a higher prevalence of physical dysfunction, sexual symptoms, and diabetes mellitus, the three categories of conditions most consistently associated with low testosterone levels. Physical function measures (including low walking speed, difficulty climbing stairs, self-reported mobility limitation and frailty) and diabetes were investigated in all three cohorts; sexual symptoms (including decreased morning erections, erectile dysfunction and decreased frequency of sexual thoughts) were available only in EMAS.

Time-course of biological effects of testosterone replacement therapy

menshealthcare@bayerhealthcare.com — Mon, 16 Apr 2012 09:00:00 +0100

This article reviewed the published literature of studies analyzing the effects of testosterone administration in hypogonadal men to estimate the onset or time-dependency effects of testosterone. The analysis consisted of studies performed with testosterone (including testosterone esters and dihydrotestosterone preparations, independent of delivery method) where:

the use of an active treatment group was compared with a matched placebo or control group
a description of the time course of the effect of active treatment was included, and
randomization, adherence to protocol and single/double-blind study design was reported.

Only full articles published in peer-reviewed medical journals were included.

Current knowledge on testosterone deficiency with practical recommendations for diagnosis and treatment

menshealthcare@bayerhealthcare.com — Mon, 02 Apr 2012 09:00:00 +0100

This article aimed to provide practical recommendations for the diagnosis of testosterone deficiency (TD) and information on the benefits and risks of testosterone replacement in middle-aged and older men through a comprehensive review of epidemiological and clinical studies. The review addressed the potential role of testosterone in general men’s health concerns, including the sexual realm, metabolic effects, body composition and mortality, and included an analysis of treatment modalities and examination of current areas of concern and uncertainty.

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Data strongly suggests a relationship between testosterone deficiency and frailty in elderly men

menshealthcare@bayerhealthcare.com — Thu, 08 Mar 2012 09:00:00 +0100

This review aimed to discuss the relationship between low testosterone level and frailty in elderly men and to evaluate the data which show that treatment of frail hypgonadal men with testosterone replacement therapy (TRT) improves physical functioning and reduces some common risk factors for cardiovascular disease.

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Long-acting testosterone undecanoate (TU) injection, but not oral TU, improves metabolic parameters in hypogonadal men

menshealthcare@bayerhealthcare.com — Thu, 01 Dec 2011 09:00:00 +0100

This randomized, double-blind, double-dummy study was the first clinical trial to compare the efficacy and safety of long-term testosterone replacement therapy using two different preparations of testosterone undecanoate (TU), in hypogonadal men with metabolic syndrome (MetS) and/or type 2 diabetes mellitus (T2DM). Patients were randomized to one of three parallel treatment arms; oral TU (80 mg twice daily), intramuscular (IM) TU (1000 mg initially, then repeated every 12 weeks from week 6) or transdermal placebo gel (3–4 g/day). After 6 months, the oral testosterone group was crossed over to receive IM TU for 6 months; the other groups continued with their initial treatment for a further 6 months.

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

menshealthcare@bayerhealthcare.com — Thu, 01 Sep 2011 19:00:00 +0100

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.

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

menshealthcare@bayerhealthcare.com — Tue, 28 Jun 2011 19:00:00 +0100

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.

Evidence-based criteria identifying late-onset hypogonadism defined

menshealthcare@bayerhealthcare.com — Wed, 08 Jun 2011 19:00:00 +0100

This was a systematic investigation of a random population sample of 3369 middle-aged and elderly men (aged 40–79 years) to establish evidence-based criteria for identifying late-onset hypogonadism in the general population on the basis of an association between symptoms and a low testosterone level. The men surveyed were participating in the European Male Aging Study (EMAS) at eight European centers. Data were collected on the men’s general, sexual, physical, and psychological health, and total testosterone levels were measured in morning blood samples and free testosterone levels were calculated. Data were randomly split into separate training and validation sets for confirmatory analyses.

A total of 32 items were considered as possible candidates for symptoms of androgen deficiency on the basis of previous recommendations and studies; all items were then screened statistically and those that were significantly associated with total or free testosterone levels were selected for independent validation and further divided into symptomatic and asymptomatic categories. The findings were published in the New England Journal of Medicine.

The addition of testosterone therapy improves erectile function in hypogonadal men who fail to respond to phosphodiesterase type 5 inhibitor (PDE5-I) therapy alone

menshealthcare@bayerhealthcare.com — Fri, 20 May 2011 19:00:00 +0100

This study aimed to confirm that testosterone replacement therapy (Testogel^®, Androgel^®) improved erectile function in men with erectile dysfunction (ED) who were nonresponders to phosphodiesterase type 5 inhibitors (PDE5-Is). The study also investigated the impact of baseline testosterone levels on response to treatment. The multicentre, multinational, double-blind, placebo-controlled study (TADTEST) included 173 men (age 45–80 years) with baseline total testosterone levels ≤400 ng/dL or bioavailable testosterone ≤100 ng/dL and inadequate response to 4 weeks of treatment with the PDE5-I tadalafil (Cialis^®) 10 mg once a day. Once-daily tadalafil treatment was continued for an additional 12 weeks and men were randomized also to receive placebo or testosterone 50 mg once daily in the form of a 1% hydro-alcoholic gel, to be increased to 100 mg if results were unsatisfactory. The Erectile Function Domain (EFD) Score of the International Index of Erectile Function (IIEF) and rate of successful intercourse attempts were the main outcomes measured.

Meta-analysis supports association between metabolic syndrome and hypogonadism; testosterone replacement therapy may improve metabolic control and reduce central obesity

menshealthcare@bayerhealthcare.com — Thu, 05 May 2011 19:00:00 +0100

A systematic review and meta-analysis of available prospective and cross-sectional studies comparing androgen levels in men with or without metabolic syndrome (MetS) was performed to analyse the relationship between androgen levels and MetS.1 Additionally, a separate meta-analysis of available randomized controlled trials reporting the metabolic effects of testosterone replacement therapy was performed. Overall, 21 quality studies were included; 13 cross-sectional, 3 longitudinal and 4 randomized controlled published trials, and 1 unpublished randomized controlled trial. Data for 2,254 men with and 6,407 men without MetS were included.

Testosterone replacement therapy improves body composition, insulin resistance and markers of atherosclerosis in men with low testosterone and metabolic syndrome

menshealthcare@bayerhealthcare.com — Thu, 21 Apr 2011 17:00:00 +0100

The aim of this study was to evaluate whether long-term testosterone replacement therapy could modify cardiovascular risk factors and atherosclerosis progression in a population of hypogonadal men with metabolic syndrome (MetS) and/or type 2 diabetes mellitus (T2DM). The randomized, double-blind, double-dummy, placebo-controlled, parallel group study enrolled 50 men (mean age 57 years) to receive intramuscular (IM) testosterone undecanoate (TU) 1000 mg every 12 weeks (n=40) or placebo transdermal gel (3-6 g daily; n=10) for 24 months. Hypogonadism was defined as total testosterone ≤11 nmol/L or free testosterone ≤250 pmol/L; MetS and T2DM were defined according to National Cholesterol Education Program-Third Adult Treatment Panel (NCEP-ATPIII) and International Diabetes Federation (IDF) criteria.

Testosterone deficiency – data available from RHYME study in 2013

menshealthcare@bayerhealthcare.com — Fri, 15 Apr 2011 17:00:00 +0100

The natural history of testosterone deficiency in men and outcomes associated with testosterone therapy: a multi-national patient registry. RC Rosen, AB Araujo, AB O'Donnell, JB McKinlay. New England Research Institutes, Watertown, MA, USA.

Despite testosterone (T) therapy being used to treat testosterone deficiency for approximately 70 years, no large scale, long term study has fully addressed the natural history of testosterone deficiency or the long term safety of testosterone treatment.

In May 2009 it was announced that a Registry of HYpogonadism in MEn (RHYME) would be established to maintain a multi-national (European) data-set of around 1,000 patients (aged 18 and over), drawn from some 20 clinical sites, diagnosed with late-onset hypogonadism (HG), hypogonadism secondary to medical illness, and classical hypogonadism (eg, Klinefelter's syndrome).1,2 Men registered on RHYME are not required to undergo T treatment for diagnosed HG.

The primary goal of RHYME is to examine the association between testosterone therapy and prostate health (eg, rate of positive prostate biopsies (primary endpoint), incidence of prostate cancer and Benign Prostatic Hyperplasia) of men with HG that some believe is put at risk by testosterone therapy. Other goals include the assessment of HG symptoms and general health outcomes in men with HG treated with T, as well as their clinical course compared to those men with HG who are not treated.

The Registry will draw on observational studies at baseline, three months, and then yearly intervals (for a minimum of two years). Data collected will include a full medical history, a physical examination, blood sampling, and patient questionnaires.

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

menshealthcare@bayerhealthcare.com — Fri, 01 Apr 2011 18:55:00 +0100

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.

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Low testosterone is common in men with coronary heart disease and negatively impacts survival

menshealthcare@bayerhealthcare.com — Fri, 11 Mar 2011 18:55:00 +0100

A total of 930 men (mean age 61 years) were followed in a prospective cohort study for a mean of 6.9 years to determine the prevalence of testosterone deficiency and to investigate the effect of serum testosterone levels on survival in men with confirmed coronary disease.1 The cohort was a consecutive series of men referred to a tertiary cardiothoracic centre for diagnostic coronary angiography between June 2000 and June 2002. Significant coronary artery disease was defined as 70% or greater stenosis in any epicardial coronary artery or 50% or greater stenosis of the main stem of the left coronary artery.

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Study shows testosterone (T) improves body composition and hip bone mineral density in elderly men with low T

menshealthcare@bayerhealthcare.com — Tue, 22 Feb 2011 14:00:00 +0100

Testosterone treatment in elderly men with subnormal testosterone levels improves body composition and BMD in the hip. J Svartberg, I Agledahl, Y Figenschau, T Sildnes, K Waterloo and R Jorde. International Journal of Impotence Research. 2008:20;378–387.

Researchers examined whether lower than normal T levels in elderly men were associated with a reduced quality of life (QoL), as well as physical and mental health, and whether T treatment could improve these conditions.

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Testosterone with diet and exercise reverses Metabolic Syndrome and improves glycemic control in hypogonadal men with newly diagnosed Type 2 Diabetes

menshealthcare@bayerhealthcare.com — Wed, 19 Jan 2011 20:00:00 +0100

In a single blind 52-week randomized clinical trial, 32 hypogonadal men (morning plasma testosterone concentration lower than 12 nmol/L, reference range >14 nmo/l) with recently diagnosed Type 2 Diabetes (T2D) and with Metabolic Syndrome (MetS) underwent supervised diet and exercise (D&E). Half of this group received D&E with testosterone administered as a relatively low dose (50 mg) gel (Testogel®) once daily. No glucose-lowering agents were administered prior to or during the study period.

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Largest international trial indicates that testosterone replacement therapy is an effective and well tolerated treatment for male hypogonadism

menshealthcare@bayerhealthcare.com — Wed, 08 Dec 2010 17:00:00 +0100

Systematic reviews of randomized, placebo-controlled clinical trials of testosterone in men, including older men (aged 60 years and over) and middle-aged men, with sexual dysfunction and hypogonadism have shown large favourable effects on libido, but moderate effects on satisfaction with erectile function.

Outcomes in clinical trials of the effect of testosterone treatment on mood have varied. However, there has been evidence that testosterone treatment results in improvements in mood, particularly in older men with hypogonadism.

The benefits of testosterone treatment on body composition have consistently been demonstrated in clinical studies of testosterone therapy in hypogonadal men or men with borderline low testosterone levels.

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Exercise performance in men with stable angina improved by testosterone over 12 month period

menshealthcare@bayerhealthcare.com — Wed, 24 Nov 2010 14:15:00 +0100

This was a double-blind, randomised, parallel group placebo-controlled trial involving a single centre study that investigated 13 (originally 15) hypogonadal men (mean T was 9.9nmol/l1) with stable angina on optimal anginal treatment randomised to Nebido 1000mg/3 months or placebo. Exercise (treadmill) testing was conducted at 3, 6, and 12 months after baseline tests along with metabolic parameters.

This was the first 12 months outcome study showing a sustained effect on time to ST depression.

There were no adverse effects.

Testosterone improves depression and quality of life scores in hypogonadal men

menshealthcare@bayerhealthcare.com — Fri, 15 Oct 2010 14:18:00 +0100

The Russian study looked at 184 men with metabolic syndrome (Met S) and hypogonadism. This was a double-blind, placebo-controlled study of Nebido 1000mg vs placebo. The baseline testosterone (T) for this 30 week study was 8.0 nmol/l. The mean baseline BMI was 35.5 kg/m21 with a reduction of 1.32 occuring in the treatment group and no change with placebo.

The baseline BDI depression score improved by 2.5 (p=0.003), AMS scale by 7.4 (p<0.001) and IIEF-5 by 3.1 (P<0.001). The strongest effect was seen in men with lowest baseline T levels.

Testogel® reduces fat and improves body composition and quality of life scores

menshealthcare@bayerhealthcare.com — Thu, 23 Sep 2010 13:00:00 +0100

This multi-centre, double-blind placebo-controlled study assessed the efficacy and safety of Testogel® (1% testosterone gel) in 352 men aged 50-80 years with late-onset hypogonadism.

The primary outcome measure was change from baseline to 6 months in lean body mass (assessed using dual-energy X-ray absorptiometry). Fat mass, total body mass, health-related quality of life (assessed using the Aging Males’ Symptoms Scale [AMS]) and serum lipid levels were also assessed.

The increase in lean body mass was significantly greater with testosterone than placebo (Figure). This increase occurred irrespective of age and baseline serum total testosterone levels. Fat mass decreased by 1.13 kg with testosterone and 0.09 kg with placebo (Figure). No significant changes in total body mass were observed with either testosterone or placebo. Significant improvements in quality of life scores were observed with testosterone (-10.8) compared with placebo (-6.9; p<0.05). Improvements in lipid parameters were also noted. No unexpected safety concerns arose during the study.

Change in lean body mass and fat mass with testosterone and placebo. *p<0.0001 versus placebo.

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Testosterone improves functional performance in elderly men with chronic heart failure

menshealthcare@bayerhealthcare.com — Tue, 17 Aug 2010 02:00:00 +0100

This 12-week, double-blind, placebo-controlled, randomised study evaluated the effect of long-acting testosterone treatment in elderly men with stable chronic heart failure (CHF). Seventy patients (median age 70 years) were recruited and randomised 1:1 to receive intramuscular Nebido or intramuscular saline at 6 week intervals. The baseline characteristics of testosterone and placebo groups were well balanced, and approximately one-third of patients in each group had hypogonadism. The study found that 12 weeks of testosterone treatment provided significant improvements from baseline in skeletal muscle function, cardiorespiratory indices and insulin resistance (HOMA-IR) that were not seen in the placebo group (Table). Furthermore, the improvements in VO2 (a measure of physical fitness) and MVC (a measure of skeletal muscle strength) were dose-dependent, i.e. the higher the change in testosterone levels, the greater the improvement. Patients were already on comprehensive therapy for heart failure, and testosterone treatment was well tolerated in these frail patients, many of whom were on multiple concomitant medications.

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Testosterone reduces visceral fat and increases muscle mass in non-obese men aged ≥ 55 years

menshealthcare@bayerhealthcare.com — Wed, 04 Aug 2010 21:00:00 +0100

This Australian, double-blind, placebo-controlled 12-month study assessed the effect of the testosterone patch on total and regional body composition (using dual-energy X-ray absorptiometry and magnetic resonance imaging) and hormonal and metabolic indices in 60 healthy but symptomatic non-obese males aged ≥55 years with total testosterone <15 nmol/L.

Testosterone levels increased by 30% with testosterone (p<0.05) and fell by 10% with placebo (p<0.05). Bodyweight, body mass index and waist circumference did not change during treatment. Fat-free mass increased with testosterone and was unchanged with placebo (Figure); skeletal muscle mass followed the same trend (p=0.008). No changes in total body fat mass, regional fat mass, percentage body fat or abdominal subcutaneous fat were observed. Visceral adipose tissue mass decreased with testosterone and increased with placebo (p=0.001 for testosterone versus placebo); changes in visceral fat correlated with changes in testosterone levels (r2=0.36; p<0.05). A trend towards increased total and low-density lipoprotein cholesterol with placebo was noted.

No significant changes in haematocrit were observed. The dropout rate was high (30%).

Change in fat-free mass with testosterone patch or placebo. *p=0.026 for the between-group differences in change from baseline to 52 weeks.

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Sat, 01 Jan 2000 13:00:00 +0100