Folate: a possible role in erectile dysfunction?

A growing body of evidence suggests a role for homocysteine (Hcys) and folate (FA) in erectile function (EF): Hcys appears to impair EF affecting endothelium via several mechanism whereas the role of FA remains to be elucidated, besides decreasing Hcys. To assess correlation between erectile dysfunction (ED) and serum levels of FA, Hcys, and B12, we enrolled 31 patients affected by ED (Group A; age 52.83?±?11.89 years) and 31 healthy adults (Group B; age 49.14?±?13.63 years). Fasting blood samples were taken for each subject. ED was assessed by the International Index of Erectile Function-5 (IIEF-5). IIEF-5 mean score was significantly lower in Group A than in Group B (10.71?±?4.24 versus 23.32?±?1.33, p?p?p?相似文献   

The effect of lifestyle modification and glycemic control on the efficiency of sildenafil citrate in patients with erectile dysfunction due to type-2 diabetes mellitus

Abstract

Objectives: We evaluated the effect of lifestyle modifications and glycemic control on the efficiency of sildenafil citrate in patients with type-2 diabetes (T2DM) and erectile dysfunction (ED).

Methods: Eighty-three men with ED due to T2DM were included in the study. The Group 1 (n?=?41) patients received lifestyle modifications (diet and exercise), and medical treatment for intensive glycemic control. In Group 2 (n?=?42), in addition to the intensive glycemic control, the patients were given sildenafil citrate® 100?mg for 2–3 per weeks. The changes in ED were compared between the two groups after three months of treatment.

Results: The mean age was 54.9?±?9.1 (26–75) years. An increase in the IIEF-5 scores was observed in 23 of 41 patients in Group 1 (44.2%) and 29 of 42 in Group 2 (55.8%). When the changes of the IIEF-5 scores were evaluated, the mean increase was 2.5 in Group 1, and 5.0 in Group 2 (p?=?0.012). The mean IIEF changes according to the duration of diabetes were 4.8 in <5 years, 3.6 in 5–10 years and 1.6 in >10 years (p?=?0.021).

Conclusions: Glycemic control and lifestyle changes are not solely adequate for a better sexual function in ED due to diabetes, and sildenafil citrate should be used additionally.     

Daily use of sildenafil 50mg at night effectively ameliorates nocturia in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia: an exploratory multicenter,double-blind,randomized, placebo-controlled study

Purpose: To compare the efficacy and safety of sildenafil 25?mg qd, 25?mg bid or 50?mg qd – on treating lower urinary tract symptoms with benign prostatic hyperplasia (LUTS/BPH).

Materials and methods: Men aged?>?45 years with LUTS/BPH were randomly assigned to receive sildenafil 25?mg qd (n?=?42), bid (n?=?41), 50?mg qd (n?=?38) or placebo (n?=?41) for 8 weeks. Changes from baseline in International Prostate Symptom Score (I-PSS), maximum urinary flow rate (Qmax) and postvoid residual urine volume (PVR) were assessed at week 4 and week 8.

Results: Sildenafil 25?mg qd (-7.3?±?5.8) and 25?mg bid (-7.0?±?5.7) exhibited significant improvements of I-PSS compared to placebo (-5.2?±?6.4) (p?=?0.020, 0.025, respectively). In particular, voiding domain was more affected than storage domain. Only sildenafil 50?mg qd improved nocturia significantly (versus placebo, p?=?0.027). Quality of life score was improved in all treatment groups. Q_max and PVR did not change significantly in all groups. All regimens were well tolerated.

Conclusions: Sildenafil 25?mg qd, 25?mg bid and 50?mg qd are safe and effective to improve LUTS/BPH in long term, along with coexisting ED. In particular, nocturia is most well-controlled by 50?mg qd.     

Sildenafil versus continuous positive airway pressure for erectile dysfunction in men with obstructive sleep apnea: a meta-analysis

Objective.?To evaluate the effectiveness of sildenafil versus continuous positive airway pressure (CPAP) for patients with erectile dysfunction (ED) and obstructive sleep apnea (OSA).

Methods.?This is a meta-analysis of a randomized controlled trial. The main outcome measures for effectiveness were the percentage of successful intercourse attempts, International Index of Erectile Function (IIEF) domain scores (erectile function, EF) and the satisfaction levels of the patients and their partners with the treatment for ED.

Results.?Two randomized controlled trials totaling 70 patients were included. Meta-analysis results are as follows: after 12 weeks of treatment, patients under sildenafil demonstrated a significant advantage over under CPAP in terms of the percentage of successful intercourse attempts [OR?=?3.24, 95% CI (2.37–4.43)], EF scores [WMD?=?3.57, 95%CI (1.68–5.45)], and the satisfaction levels of the patients and their partners with the treatment for ED [OR?=?3.56, 95% CI (1.27–9.98)].

Conclusion.?Current clinical studies might confirm that both therapeutic methods were safe and effective, but sildenafil was superior to CPAP in the treatment of ED in men with OSA. We conclude that new therapeutic agents or a combination of the two methods should be studied further.     

Increased visceral adiposity index associated with sexual dysfunction in men

Objective: Visceral adipose index (VAI) is a novel parameter for the evaluation of visceral obesity. As we know that obesity is a risk factor for erectile dysfunction (ED). So, in this study, we compared the VAI levels between the men with ED and without ED.

Materials and method: A total of 177 men were included in the study. Ninety-five men with ED and 82 men without ED (control). All men were evaluated for ED by Index of Erectile Function-5 items (IIEF-5). VAI levels were calculated using body mass index, high density lipoprotein and tryglyceride levels.

Results: Mean age was 53.5 (38–69) in men who have ED and 53.1 (34–69) in control. The men with ED had higher body mass index (BMI), triglyceride (TG) levels, higher waist circumference (WC) and lower high-density lipoprotein-cholesterol (HDL-C) levels. Mean VAI level was 5.18?±?2.50 in study group and 3.47?±?1.76 in control goup, respectively. VAI levels were statistically higher in men with ED (p?Discussion: The simplicity of WC and BMI measurement and TG and HDL assessment, make VAI an easily applicable index for the evaluation of visceral fat dysfunction. VAI can be useful index for the evaluation and calculation of erectile dysfunction risk.     

Increased prevalence of premature ejaculation in men with metabolic syndrome

This prospective study aimed to investigate the relationship between metabolic syndrome (Met S) and premature ejaculation (PE) among men. The study included 300 consecutive male patients (53.6 y?±?8.7) who attended the urology clinic (December 2013–September 2014), mostly complaining of renal/ureteric calculi. A diagnostic approach was undertaken to include demographics, clinical features and laboratory investigations of the study subjects. Both erectile function and PE were evaluated using the International Index of Erectile Function (abridged form, IIEF-5) and Premature Ejaculation Diagnostic Tool (PEDT) questionnaires, respectively. Results identified 182 (60.7%) men had Met S. Prevalence of PE was significantly higher in the subjects with Met S than the controls (35.2% vs 7.6%, p?< 0.001). Patients with Met S and PE had significantly higher PEDT scores (15.4 vs 6.7), smaller waist circumference (108.3?cm vs 111.5?cm) and higher fasting blood sugar (187?mg% vs 161?mg%) than those with no PE (p?p?=?0.047 and <0.001, respectively) with PE in Met S. In conclusion, PE has a high prevalence in Met S. Patients with Met S should be questioned about PE. Both ED and systolic hypertension may be associated with PE. Prevention of Met S should be considered, and this may be of help to decrease the prevalence of PE.     

The relationship between vitamin D level and erectile dysfunction in patients with type 2 diabetes mellitus

Recent studies have suggested that a relationship could exist between 25-hydroxyvitamin D [25(OH)D] deficiency and erectile dysfunction (ED). The present study evaluated the relationship between 25(OH)D levels and ED in male patients with type 2 diabetes mellitus (DM). The study included 98 patients with type 2?DM aged between 18–80 years. The International Index of Erectile Function (IIEF-5) Questionnaire was administered. The patients were divided into three groups according to IIEF-5 scoring: IIEF-5 score between 5–10, severe ED; IIEF-5 score between 11–20, moderate ED; IIEF-5 score between 21–25, no ED. Biochemical parameters, 25(OH)D and hormonal analysis tests were obtained in all patients. All parameters were compared between these three groups. Of 98 patients included in the study, 32 had severe ED, 45 had moderate ED and 21 had no ED. The mean age was 55.12?±?9.39 years and the mean 25(OH)D level was 13.69?±?8.15?ng/ml. When the three groups were compared, 25(OH)D levels were significantly lower in patients with the IIEF-5 score between 5–10 (p?=?0.020). There was a moderate positive relationship between IIEF-5 score and 25(OH)D level (r?=?0.21, p?=?0.038). The patients with severe ED have considerably lower 25(OH)D levels.     

Oral testosterone undecanoate reverses erectile dysfunction associated with diabetes mellitus in patients failing on sildenafil citrate therapy alone

Aims: To evaluate the cause of failure of sildenafil citrate (Viagra^®) to restore erections in patients with organic erectile dysfunction (ED) associated with type II diabetes mellitus (DM) and receiving oral antidiabetic drugs. Methods: Diabetic ED patients (n = 120), aged 43-74 years, failing to respond at least three times to 100 mg Viagra were evaluated. After at least 2 weeks' treatment with oral testosterone undecanoate (Andriol^®), 100 mg Viagra was used before coitus. ED was assessed with the International Index of Erectile Function (IIEF). Serum total testosterone, prolactin, thyroid stimulating hormone, lipid profile and prostate-specific antigen (PSA) were determined by standard methods and prostate volume by digital rectal examination. Age-matched diabetic ED patients (n = 100) served as controls for baseline values. Results: Viagra non-responders had, at baseline, significantly lower testosterone and more depressed libido than controls. Andriol restored testosterone to normal levels and increased libido. In 84/120 (70%) Viagra non-responders, combined therapy with Andriol induced satisfactory erections, a significant increase in IIEF scale (question (Q) 3 from 2.0 ± 0.2 to 3.7 ± 0.3, Q4 from 1.9 ± 0.1 to 3.4 ± 0.2, Q12 from 1.0 ± 0.1 to 4.2 ± 0.4) and increased sexual contacts from 0.5 to 3-4 per month. No adverse events were noted, and PSA levels remained below 4 ng/ml. Conclusion: Decreased testosterone levels in patients with ED and type II DM receiving oral antidiabetic agents may be responsible for failure to respond to sildenafil citrate therapy. Combination with oral testosterone undecanoate restores sexual function in these patients.     

The imbalance of sex-hormones related to depressive symptoms in obese men

Obese men may present hypogonadothrofic hypogonadism, mainly related to higher insulinemia and aromatase activity. Our objectives were to evaluate the relationship of sex-hormones profiles and frequency of depressive symptoms in 43 obese men, in a cross-sectional study. They had 19–60 years, and body mass index 30–50?kg/m². LH, total and free testosterone (TT and FT), estradiol (E₂), sex hormone binding globulin, estradiol/total testosterone ratio (E₂/T) were analyzed. Depressive symptoms were evaluated by “beck depression inventory” (BDI), and significant depression was considered if BDI?≥?16.Thirty-four (80%) presented low TT levels, but only 4 (14%) had low free testosterone and hypogonadism symptoms; 12 of 43 (28%) presented increased E₂. Forty five (56%) presented depressive symptoms, but 16 (28% of the 45) had significant depression. BDI correlated positively with E₂ (r?=?0.407; p?=?0.001) and E₂/T (r?=?0.473; p?=?0.001), but not TT or FT. Patients with significant depressive showed higher levels of estradiol (136?±?48 versus 103?±?48?pg/ml, p?=?0.02) and E₂/T (16.0?±?9.9 versus 9.8?±?4.6; p?=?0.002) (mean?±?SD).In conclusion, obese men may present relatively excess of estradiol and deficiency in testosterone, leading to an imbalance between these two hormones. The greater this imbalance, the more depressive symptoms had our patients.     

Circadian rhythm of hot flashes and activity levels among prostate cancer patients on androgen deprivation therapy

Abstract

Background: Modifiable risk factors contribute to the pathogenesis of cardiovascular disease (CVD) and erectile dysfunction (ED). We aimed to compare the knowledge about the contribution of modifiable risk factors to the pathogenesis of CVD and ED. The impact of patients’ having modifiable risk factors on the awareness of their negative influence on the development of CVD and ED was examined.

Methods: To this multicenter cohort study, we included 417 patients with CHD who had been hospitalized in the cardiology or cardiac surgery department during the previous six weeks and underwent cardiac rehabilitation in one of the five centers. Knowledge about modifiable risk factors was collected. ED was assessed by an abridged IIEF-5 questionnaire. Comparisons between groups were conducted using the Student’s t-test, Mann–Whitney U test, and Kruskal–Wallis test. Relationships were analyzed with Spearman's rank correlation coefficient.

Results: The mean number of correctly identified risk factors for CVD was significantly higher than those for ED (3.71?±?1.87 vs. 2.00?±?1.94; p?<?.0001). Smoking was the most recognized risk factor both for CVD and ED. Dyslipidemia was least frequently identified as a risk factor for CVD. Sedentary lifestyle was the only risk factor whose incidence did not affect the level of patient knowledge.

Conclusions: Cardiac patients with ED know more about risk factors for CVD than ED. It is necessary to include information about the negative impact of modifiable risk factors on sexual health into education programs promoting healthy lifestyles in men with cardiovascular diseases.     

The impact of metabolic syndrome on serum total testosterone level in patients with erectile dysfunction

Abstract

Objectives: To determine the association between metabolic syndrome (MetS) and serum testosterone levels (TT) in patients with erectile dysfunction (ED).

Methods: This study included 280 ED patients above 40-years-of-age. Participants were divided into two groups according to 2005 criteria of International Diabetes Federation. The severity of ED was determined according to the International Index of Erectile Function-EF (IIEF-EF score; 0–10 severe ED, 11–25 mild to moderate ED). The severity of ED, serum TT levels and other MetS components were compared between the groups.

Results: The mean age of the patients was 55.7?±?8.2 years. One hundred eighteen patients (%42.1) had MetS. Sixty-eight patients with MetS (57.6%) and 71 patients without MetS (43.8%) had severe ED (p?=?0.031). A total of 46 (16.4%) patients had hypogonadism. Hypogonadism was seen more prevalent in patients with MetS (22.9% vs. 11.7%, p?=?0.013). Logistic regression analyses for ED risk factors demonstrated that abnormal FBG increased the relative risk of severe ED up to 10.7-fold (p?<?0.001) but not presence of hypogonadism (p?=?0.706).

Conclusion: Metabolic syndrome was seen in almost half of the patients with ED. ED was more severe among MetS patients. Hypogonadism alone is a not risk factor for severe ED.     

Erectile dysfunction,loss of libido and low sexual frequency increase the risk of cardiovascular disease in men with low testosterone

Introduction: Testosterone deficiency increases the cardiovascular disease (CVD) risk.

Aim: To evaluate the effect of erectile dysfunction (ED), sexual frequency and hypogonadal symptoms on CVD risk.

Methods: A total of 395 hypogonadal men aged 45–74 years were surveyed using the Androgen Deficiency in the Aging Male and the International Index of Erectile Function.

Main outcome measures: The 10-year CVD risk was measured with the Framingham Risk Score. Logistic regression was performed to obtain the odds ratios of sexual function and hypogonadal symptoms for a 10-year CVD risk ≥20% (high risk).

Results: The mean age was 56.1?±?6.7 years. The mean 10-year CVD risk of the whole cohort was 18.1%?±?11.4%, while 131 subjects (33.2%) were classified as high risk. Logistic regression revealed that ED severity was associated with CVD risk [OR?=?2.37 (CI 1.24–4.51) for mild-to-moderate ED, OR?=?4.39 (1.78–8.43) for moderate ED and OR?=?12.81 (4.65–26.11) for severe ED]. Compared to sexual frequency <1 per month, sexual frequency?≥4 decreased the risk of high CVD risk [OR?=?0.35 (0.23–0.780)]. Loss of libido [OR?=?2.95 (1.91–4.12)] and less strong erection [OR?=?3.87 (CI 2.11–4.95)] increased the risk of high CVD risk. All remained significant after adjustment for age and testosterone.

Conclusions: ED, decreased sexual frequency and loss of libido predict a high 10-year CVD risk in hypogonadal men.     

Atmospheric carbon dioxide concentration variations in Rome: relationship with traffic level and urban park size

Carbon dioxide (CO₂) concentration variations in Rome in the period January 2009 to December 2010 was monitored. Five representative sites (T sites) in the city centre with different traffic levels and urbanistic characteristics, and four urban parks (P sites) of different sizes were selected. The regression analysis underlines the significant (p?≤?0.05) correlation between traffic levels and CO₂ concentration. Considering the daytime CO₂ concentration peak among T sites, Cerchi Street and Teatro Marcello Street, located in the city centre and closed by buildings, showed the highest traffic levels (85?±?3 and 63?±?2 cars min^?1, respectively) and the highest CO₂ concentration (512?±?11 and 488?±?8 ppm, respectively). With regards to the considered P sites, those extending over the largest surface areas (Villa Pamphilj Park and Villa Borghese Park, 180 and 80 ha, respectively) characterized by large tree coverage (81 ha and 60 ha, respectively) had a significant lower CO₂ concentration (404?±?9 ppm, mean value) than those extending over a small surface area (Villa Torlonia Park and Villa Celimontana Park, 14 ha and 11 ha, respectively). More efforts should be made to further reduce CO₂ concentration in the cities in order to ameliorate ecosystem services related to urban parks.     

Association of shorter mean telomere length with large artery stiffness in patients with coronary heart disease

Background.?Accumulating evidence implicates leukocyte telomere length (LTL) shortening as a potential risk predictor for cardiovascular disease. Arterial stiffness chronicles the cumulative burden of cardiovascular disease risk factors. Therefore, the capacity of LTL to predict arterial stiffness was examined.

Methods.?A total of 275 unrelated Chinese males: 163 patients with coronary artery disease (CAD) and 112 healthy controls, 40–73 years of age were included in this study. The relative telomere length of leukocytes was determined by a real-time fluorescence quantitative polymerase chain reaction (PCR). Large artery stiffness was measured with carotid-femoral pulse wave velocity (PWV).

Results.?The relative telomere length (T/S) ratio was significantly shorter in patients with CAD (0.79?±?0.26) than in control subjects (1.08?±?0.22) (p?<?0.001). The correlation between LTL and PWV in patients with CAD was stronger than that in the controls (r?=??0.467, r²?=?0.227, p?<?0.001 for patients with CAD versus r?=??0.223; r ²?=?0.050; p?=?0.018 for controls). The log_e-transformed T/S ratio was inversely correlated with age (r?=??0.345; p?<?0.001), PWV (r?=??0.326; p?<?0.001) and C-reactive protein ( r?=??0.133; p?=?0.027).

Conclusions.?The data show an association of leukocyte telomere length shortening with increased arterial stiffness and cardiovascular burden, suggesting that telomere length is a biomarker of large artery elasticity and CAD. Further studies are warranted to study the role of LTL dynamics in the pathogenesis of atherosclerosis.     

Interleukin-18 and testosterone levels in men with metabolic syndrome

Objective: Interleukin 18 (IL-18) is an adipokine associated with obesity. Data about the relationship of IL-18 to the metabolic syndrome (MS) are still scarce. Low testosterone (T) levels are common in men with MS, but we did not find data about the levels of IL-18 in men with low T. The aim of this study was to determine the levels of IL-18 in men with MS with or without low T.

Patients and methods: A total of 251 men were included in the study. Of them 218 had MS (IDF 2005) and they were divided according to their morning total testosterone (TT) level (cutoff 10.4?nmol/l) into two groups: MS-low T (N?=?84) and MS-normal T (N?=?134). The control group consisted of 33 men without MS and low T. IL-18 was determined in serum using enzyme-linked immunosorbent assay. A small group of eight men with MS and low T levels received testosterone therapy for three months and physical and laboratory parameters were monitored at the end of that period.

Results: MS men were at mean age (±SD)?=?53.77?±?9.59 years; body mass index (BMI)?=?34.0?±?6.3?kg/m²; and TT?=?12.59?±?5.66?nmol/l. The control group was at age?=?52.12?±?5.2 years (NS); BMI?=?25.6?±?2.4?kg/m² (p?p?p?p?p?p?Conclusions: In this study, higher IL-18 levels were found in the presence of MS compared to healthy men, but they did not differ between men having MS with or without LOH.     

Association between long-term erectile dysfunction and biochemical recurrence after permanent seed I125 implant brachytherapy for prostate cancer. A longitudinal study of a single-institution

We aimed to investigate the predictive factor of erectile dysfunction (ED) in prostate cancer (PCa) patients who underwent low-dose permanent I¹²⁵ seed implant brachytherapy and to investigate if ED could represent a patient’s reported outcome measures (PROMs) of efficacy of BT and indirectly associated with biochemical recurrence free survival (BRFS). From 2000 to 2012, 176 consecutive patients with low-risk PCa underwent BT. ED was evaluated with the International Index of Erectile Function (IIEF-5). Cox regression analysis was performed to assess significant predictors of mild-to-severe ED and BRFS after BT, including covariates. The 10-year actuarial rate of ED was 66%. Subjects with severe ED had higher values of D90 (183.0 versus 177.0; p?p?p?p?=?0.20), while D90?≤?180?Gy independently predicted BCR (HR: 4.65; [95%CI: 1.25–17.34]; p?125 implant, but it is not associated with better BRFS.     

Dutasteride improves bone mineral density in male patients with lower urinary tract symptoms and prostatic enlargement: a preliminary study

Introduction: We studied the effect of dutasteride on bone mineral density (BMD) in aging male patients with lower urinary tract symptoms (LUTS) and prostatic enlargement.

Methods: We prospectively studied 17 patients with LUTS and prostatic enlargement. Before and 1 year after dutasteride (0.5?mg daily), we assessed International Prostate Symptom Score (IPSS), prostatic volume (PV), serum prostatic-specific antigen (PSA) and testosterone. BMD in the lumbar and femur was measured by DEXA method.

Results: Dutasteride significantly reduced PV (from 51?±?24 to 34?±?17?ml, p?p?p?2, p?2, p?2, p?Conclusions: Dutasteride has a potential to improve BMD with elevation of serum testosterone in aging male patients with LUTS and prostatic enlargement.     

Research of stroke combined hyperlipidemia-induced erectile dysfunction in rat model

Abstract

Objective: The study was aimed to evaluate the influences of erectile dysfunction (ED) in a rat model of stroke combined with hyperlipidemia (HLP).

Methods: Male Sprague–Dawley rats were divided into control and hyperlipidemia (HLP) groups. HLP model was constructed by feeding with high-fat and cholesterol diets. Serum levels of total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL), triglyceride (TG), and non-HDL were identified to check the model was success. Stroke model was established by FeCl₃. ICP/MAP value was detected to evaluate the erectile function of rats. Serum level of lipoproteins and the expressions of endothelial nitric oxide synthase (eNOS), vascular endothelial growth factor (VEGF) were detected by ELISA. Hematoxylin–eosin (HE) staining of corpus cavernosum and measurement of penis length were utilized to assessment erectile function. Western blot was used.

Results: TC, TG, LDL, and non-HDL-C in serum were up-regulated, while HDL level was attenuated. After treatment, the serum lipid level recovered. From the ICP/MAP values, the erectile function of both two treatment groups recovered. The expression of PDE5A was up-regulated, while the levels of eNOS and cGMP were suppressed after surgery. The length of penis was decreased, and corpus cavernosum was damaged following HLP and stroke. However, the erectile function was recovered after treatment.

Conclusion: Stroke combined HLP caused ED through NO-cGMP-PDE5 pathway.     

A randomized,double-blind,placebo-controlled trial of testosterone gel on body composition and health-related quality-of-life in men with hypogonadal to low-normal levels of serum testosterone and symptoms of androgen deficiency over 6 months with 12 months open-label follow-up

Introduction: The clinical significance of low to low-normal testosterone (T) levels in men remains debated. Aim: To analyze the effects of raising serum T on lean body mass (LBM), fat mass (FM), total body mass, and health-related quality-of-life (HRQoL). Methods: Randomized, double-blind, placebo-controlled study. Men, aged 50–80 years, with serum total T<15 nmol/L and bioavailable T < 6.68 nmol/L, and a Aging Males’ Symptoms (AMS) total score >36, received 6 months treatment with transdermal 1% T gel (5–7.5?mg/day; n =183) or placebo gel (n =179), followed by 12 months open-label with T in all. Results: After 6 months, LBM increased in T- treated patients by 1.28?±?0.15?kg (mean ± SE) and FM decreased by 1.16?±?0.16?kg, with minor changes with placebo (LBM +0.02?±?0.10?kg and FM ?0.14?±?0.12?kg; all p < 0.001, T group vs. placebo). Changes were largely similar across subgroups of age, baseline total testosterone, and baseline BMI. Total HRQoL improved compared with placebo (p < 0.05, T group vs. placebo). Conclusions: Six months 1% T gel improved body composition and HRQoL in symptomatic men with low to low-normal T, with further improvements over the following 12 months.