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Purpose: We investigated the effects of long-term testosterone therapy on urinary and sexual function, and quality of life in hypogonadal men.Materials and Methods: We performed an observational, prospective, cumulative registry study in 656 men with a mean ± SD age of 60.7 ± 7.2 years who had total testosterone 12.1 nmol/l or less and symptoms of hypogonadism. In the testosterone treated group 360 men received parenteral testosterone undecanoate 1,000 mg/12 weeks for up to 10 years. The 296 men who elected against testosterone therapy served as controls. From each group 82 patients were propensity matched by age, waist circumference and body mass index, resulting in 82 matched pairs of 164 men. Data were analyzed and estimated differences between the groups were adjusted for components of metabolic syndrome and quality of life.Results: We found significant decreases in I-PSS (International Prostate Symptom Score) and post-void bladder volume (each p

Summary In daily practice, clinicians are often confronted with obese type 2 diabetes mellitus (T2DM) patients for whom the treatment plan fails and who show an inadequate glycemic control and/or no sustainable weight loss. Untreated hypogonadism can be the reason for such treatment failure. This case describes the profound impact testosterone therapy can have on a male hypogonadal patient with metabolic syndrome, resulting in a substantial and sustained loss of body weight, pronounced improvement of all critical laboratory values and finally complete remission of diabetes. Learning points: Hypogonadism occurs frequently in men with T2DM. In case of pronounced abdominal fat deposition and T2DM, the male patient should be evaluated for testosterone deficiency. Untreated hypogonadism can complicate the successful treatment of patients with T2DM. Under testosterone therapy, critical laboratory values are facilitated to return back to normal ranges and even complete remission of diabetes can be achieved.

Objectives:In the absence of large, prospective, placebo-controlled studies of longer duration, substantial evidence regarding the safety and risk of testosterone (T) therapy (TTh) with regard to cardiovascular (CV) outcomes can only be gleaned from observational studies. To date, there are limited studies comparing the effects of long-term TTh in men with hypogonadism who were treated or remained untreated with T, for obvious reasons. We have established a registry to assess the long-term effectiveness and safety of T in men in a urological setting. Here, we sought to compare the effects of T on a host of parameters considered to contribute to CV risk in treated and untreated men with hypogonadism (control group).Patients and Methods:Observational, prospective, cumulative registry study in 656 men (age: 60.7 ± 7.2 years) with total T levels ≤12.1 nmol/L and symptoms of hypogonadism. In the treatment group, men (n = 360) received parenteral T undecanoate (TU) 1000 mg/12 weeks following an initial 6-week interval for up to 10 years. Men (n = 296) who had opted against TTh served as controls. Median follow-up in both groups was 7 years. Measurements were taken at least twice a year, and 8-year data were analyzed. Mean changes over time between the 2 groups were compared by means of a mixed-effects model for repeated measures, with a random effect for intercept and fixed effects for time, group, and their interaction. To account for baseline differences between the 2 groups, changes were adjusted for age, weight, waist circumference, fasting glucose, blood pressure, and lipids.Results:There were 2 deaths in the T-treated group, none was related to CV events. There were 21 deaths in the untreated (control) group, 19 of which were related to CV events. The incidence of death in 10 patient-years was 0.1145 in the control group (95% confidence interval [CI]: 0.0746-0.1756; P < .000) and 0.0092 in the T-treated group (95% CI: 0.0023-0.0368; P < .000); the estimated difference between groups was 0.0804 (95% CI: 0.0189-0.3431; P < .001). The estimated reduction in mortality for the T-group was between 66% and 92%. There were also 30 nonfatal strokes and 26 nonfatal myocardial infarctions in the control group and none in the T-treated group.Conclusion:Long-term TU was well tolerated with excellent adherence suggesting a high level of patient satisfaction. Mortality related to CV disease was significantly reduced in the T-group.

Background and significance Obesity is a chronic disease, warranting long-term medical intervention. We evaluated effects of testosterone (T) therapy (Th) in men with T deficiency with normal weight, overweight and obesity on anthropometric and metabolic parameters, compared with untreated men. Methods Hypogonadal men (n = 823) with total T ≤ 12.1 nmol/L (age: 60.6 ± 7.0 years) participated in an ongoing registry study. Among these men 474 (57.6%) were obese, 286 (34.8%) overweight and 63 (7.7%) had normal weight. T undecanoate injections were administered to 428 men and 395 remained untreated. Anthropometric and metabolic parameters were measured at least twice a year and changes adjusted for confounding factors to account for baseline differences between groups. Results Long-term TTh in hypogonadal men, irrespective of weight at baseline, produced improvements in body weight, waist circumference (WC) and body mass index (BMI). Furthermore, TTh decreased fasting blood glucose and HbA1c and improved lipid profiles. Gradual decreases in blood pressure (systolic and diastolic) and pulse pressure occurred in men treated with T in each group. Marked reductions in mortality and major cardiovascular events were recorded in men receiving TTh. Conclusions Our findings demonstrate that TTh produces reductions in weight, WC, and BMI. There were 77 (19.5%) deaths in the untreated groups and 23 (5.4%) in the T-groups. Based on these findings we suggest that long-term TTh in overweight and obese hypogonadal men produces progressive and sustained clinically meaningful weight loss and that TTh may contribute to reductions in mortality and incident major adverse cardiovascular events.

Background: In the literature, effects of testosterone on lipid pattern in men with hypogonadism are inconsistent. Methods: Of 324 men with hypogonadism and T2DM in a registry, 152 received TU 1000 mg/12 weeks (T-group), 172 opted against treatment (CTRL). Mean changes over time between groups were compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction. Changes were adjusted for age, weight, waist circumference, fasting glucose, blood pressure (BP), lipids and quality of life to account for baseline differences between the two groups. Results: Mean age: 62.7±5.1 years. Follow-up: Mean: 7.9, median: 9 years. All values are in mmol/L ±SE. Total cholesterol decreased by 2.8±0.1 at 10 years (T-group) and increased by 1.0±0.1 (CTRL). Estimated adjusted difference between groups: 3.9 (p Conclusions: Long-term TTh with TU in men with hypogonadism and T2DM sustainably improved lipid profile which worsened in untreated controls. Disclosure F. Saad: Employee; Self; Bayer AG. Stock/Shareholder; Self; AbbVie Inc., Amgen Inc., Bayer AG. K.S. Haider: Speaker's Bureau; Self; Bayer AG. A. Haider: Research Support; Self; Bayer AG. Speaker's Bureau; Self; Bayer AG. Funding Bayer AG

Background: Men with T2DM have a high prevalence of hypogonadism. Methods: In a registry of 823 men with hypogonadism, 324 men (39%) had T2DM. 152 received TU 1000 mg/12 weeks (T-group), 172 opted against treatment (CTRL). Changes over time between groups were compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction. Changes were adjusted for age, weight, waist circumference, fasting glucose, blood pressure, lipids and quality of life to account for baseline differences between the two groups. Results: Mean follow-up 7.9±2.4, age: 62.8±5.1 years. T-group: baseline HbA1c: 9.1±1.2%. HbA1c progressively decreased by 2.7±0.3% at 10 years. CTRL: baseline HbA1c: 7.8±0.7%. HbA1c increased by 2.9±0.3%. Estimated adjusted difference between groups: 5.6% (p Conclusions: Long-term testosterone therapy with TU in men with hypogonadism and T2DM progressively improved glycemic control which worsened in untreated hypogonadal controls. Disclosure F. Saad: Employee; Self; Bayer AG. Stock/Shareholder; Self; AbbVie Inc., Amgen Inc., Bayer AG. K.S. Haider: Speaker's Bureau; Self; Bayer AG. A. Haider: Research Support; Self; Bayer AG. Speaker's Bureau; Self; Bayer AG. Funding Bayer AG

Background: Testosterone is inversely correlated with weight and waist circumference (WC). Methods: Of 324 men with hypogonadism and T2DM in a registry, 257 (79.3%) were obese, 60 (18.5%) overweight and 7 (2.2%) had normal weight. 152 received TU 1000 mg/12 weeks (T-group), 172 opted against treatment (CTRL). Changes over time between groups were compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction, and adjusted for age, weight, WC, fasting glucose, blood pressure, lipids and quality of life to account for baseline differences between the two groups. Results: Mean age: 62.7±5.1, follow-up: mean: 7.9, median: 9 years. T-group: weight decreased by 21.4±0.5 kg at 10 years. CTRL: weight increased by 4.8±0.4 kg. Estimated adjusted difference between groups: 26.2 kg (p Conclusions: Long-term testosterone therapy with TU in men with hypogonadism and T2DM sustainably improved anthropometric measures which worsened in untreated controls. Disclosure A. Haider: Research Support; Self; Bayer AG. Speaker's Bureau; Self; Bayer AG. K.S. Haider: Speaker's Bureau; Self; Bayer AG. F. Saad: Employee; Self; Bayer AG. Stock/Shareholder; Self; AbbVie Inc., Amgen Inc., Bayer AG. Funding Bayer AG

Background: Potential cardiovascular risk as a result of testosterone therapy is controversially discussed. Methods: In a registry of 823 men with hypogonadism, 324 men (39%) had T2DM. 152 received TU 1000 mg/12 weeks (T-group), 172 opted against treatment (CTRL). Changes over time between groups were compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction, and adjusted for age, weight, WC, fasting glucose, blood pressure, lipids and quality of life to account for baseline differences between the two groups. Results: Mean age: T-group: 61.8±5.1, CTRL: 63.6±4.9 years. Follow-up: T-group (CTRL): mean: 7.4 (8.3), median: 8 (9) years. T-group: 54 patients (35.5%) had had a previous cardiovascular disease (CVD, defined as myocardial infarction, stroke, or diagnosis of coronary artery disease). CTRL: 68 patients (39.5%) (p=0.4574). 64 men (42.1%) had been smokers at baseline (T-group), 66 (38.4%) in CTRL (p=0.4939). Most classical risk factors were significantly higher at baseline in the T-group compared to CTRL: BMI (36.4±4.5 vs. 33.3±5.3 kg/m²), systolic blood pressure (162.6±13.1 vs. 145.4±14.7 mmHg), diastolic blood pressure (97.2±10.7 vs. 84.7 vs. 10.3 mmHg), LDL (4.6±0.7 vs. 4.0±1.4 mmol/L), with no significant difference in HDL. Glycemic control was worse in the T-group: HbA1c 9.1±1.2 vs. 7.8±0.7%, HOMA-IR 10.2±2.1 vs. 7.5±1.3. Mortality: during the entire observation time, 12 patients (7.8%) died in the T-group and 43 (25%) in CTRL (p Conclusions: Mortality, myocardial infarctions and strokes were reduced in men with hypogonadism and T2DM receiving long-term testosterone therapy. Disclosure K.S. Haider: Speaker's Bureau; Self; Bayer AG. A. Haider: Research Support; Self; Bayer AG. Speaker's Bureau; Self; Bayer AG. F. Saad: Employee; Self; Bayer AG. Stock/Shareholder; Self; AbbVie Inc., Amgen Inc., Bayer AG. Funding Bayer AG

Background: In the 2018 ADA Standards of Medical Care in Diabetes checking testosterone in men with diabetes was added as new recommendation. Methods: A registry of hypogonadal men (testosterone ≤12.1 nmol/L) was initiated in 2004 in a urological setting. By 2018, 324 of 823 patients (39%) had T2DM diagnosed and treated in a diabetes center. 152 of these men received testosterone undecanoate (TU) injections 1000 mg/12 weeks (T-group) following an initial 6-week interval. Anthropometric and metabolic parameters were measured at least twice a year and fasting insulin obtained from the diabetes center to calculate HOMA-IR. Results: Mean follow-up was 7.9, maximum 12 years. 51 patients (33.6%) were in remission at the last measurement. Their average baseline age was 61±4.11 years. HbA1c dropped from 8.6±1.01% at baseline to 5.45±0.18%, fasting glucose from 7.8±1.2 mmol/L to 5.4±0.09 mmol/L. HOMA-IR dropped from 9.76±2.74 to 1.98±0.54. Triglycerides decreased from 3.41±0.57 to 2.18±0.11 mmol/L. Anthropometric parameters: Body weight declined progressively from 112.9±13.2 to 90.2±7.4 kg, waist circumference from 110.7±7.6 to 97.8±4.6 cm. All patients had been on oral antidiabetic medication (metformin) at baseline. 17 patients were on insulin at an average dose of 25.3±5.9 units per day. The average observation time was 124.1±22.7 months (10.3±1.9 years). The average time to discontinuation of diabetes medication was 107.2 months (8.9 years). Medication adherence to TU was 100% as all injections were administered in the urology office and documented. Discussion: The registry was not designed to study the effects of testosterone on T2DM. Remission of T2DM has not been described in the literature and was unexpected. Conclusions: Long-term testosterone treatment in hypogonadal men may result in remission of T2DM. Disclosure K.S. Haider: Speaker's Bureau; Self; Bayer AG. A. Haider: Research Support; Self; Bayer AG. Speaker's Bureau; Self; Bayer AG. F. Saad: Employee; Self; Bayer AG. Stock/Shareholder; Self; AbbVie Inc., Amgen Inc., Bayer AG. Funding Bayer AG

Background: Testosterone and its metabolite estradiol are essential factors in bone metabolism, and hypogonadism is an established risk factor for osteoporosis. Material and Methods: In a registry study of otherwise unselected men with hypogonadism in a urological office, 102 of 805 patients (13%) had osteoporosis diagnosed and treated elsewhere. 69 received TTh with TU 1000 mg/12 weeks (T-group). 33 had opted against TTh and served as controls (CTRL). BMD was measured at least once a year by using a whole body dual-energy X-ray densitometer (Norland XR-800). 10-year data are reported. Changes over time between groups were compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction, and adjusted for age, weight, waist circumference, fasting glucose, blood pressure and lipids to account for baseline differences between groups. Results: Baseline age: 54.5±8.2 (T-group), 64.9±4.1 years (CTRL). Mean (median) follow-up was 7.5±2.3 (8) years in the T-group and 8.9±1.1 (9) years in CTRL. 36 (52%) in the T-group had Klinefelter’s syndrome (KS) which, in the majority of cases, was diagnosed secondary to the diagnosis of osteoporosis. 7 patients had primary hypogonadism other than KS, 6 had a history of alcohol abuse, 4 had Crohn’s disease, and 3 had had a kidney transplant. All patients were on Vitamin D-calcium supplements. 64 patients (93%) in the T-group and 23 (70%) in CTRL were on bisphosphonates at baseline. 11 patients (16%) in the T-group and 11 (33%) in CTRL discontinued bisphosphonates due to side effects. T-scores progressively improved from -3.39±0.56 to -1.19±0.03 after 10 years (T-group) and worsened from -3.01±0.3 to -3.83±0.53 in CTRL, adjusted difference between groups: 2.45 (p

Background: Weight loss in obese subjects is notoriously difficult to achieve through lifestyle interventions, and even harder to maintain long-term. Testosterone therapy has shown promising results in long-term but not short-term studies. Material and Methods: In an observational registry study of 805 men with hypogonadism in a urological office, 462 (57.4%) were obese. 273 received TTh with TU 1000 mg/12 weeks (T-group) while 189 opted against TTh and served as controls (CTRL). Measurements were performed 1-4 times a year. 10-year data are reported. Changes over time between groups were compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction, and adjusted for age, weight, waist circumference, fasting glucose, blood pressure and lipids to account for baseline differences between groups. Results: Baseline age: 59.8±6.1 (T-group), 63.5±5 years (CTRL). Mean (median) follow-up: 8 (9) years (T-group) and 7.5 (8) years (CTRL). Total observation time: 3588 patient-years. Weight progressively decreased by 22.9±0.3 kg (p

INTRODUCTION AND OBJECTIVES:The high prevalence of hypogonadism in men with T2DM has caused the American Diabetes Association to recommend measuring testosterone in these patients in their 2018 gui...

Background: 3 studies reported an increased cardiovascular risk with TTh while hundreds of studies have demonstrated cardiovascular benefits of TTh in men with hypogonadism. Material and Methods: A prospective, cumulative registry study to investigate long-term effectiveness and safety of depot TU to treat hypogonadism was established in 2004 in a urological setting. Of 805 hypogonadal men, 412 received parenteral TU 1000 mg/12 weeks following an initial 6-week interval (T-group) for up to 12 years. 393 men opted against TTh and served as controls (CTRL). Mean changes over time between groups were compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction and adjusted for age, weight, waist circumference, fasting glucose, blood pressure and lipids to account for baseline differences between groups. Results: Baseline age: 57.7±7.4 (T-group), 63.7±4.8 years (CTRL) (p

Background: The prevalence of hypogonadism in men with hypertension is high and may be related to overweight and obesity. In an ongoing registry study in a single urology practice, we monitored blood pressure and hemodynamic parameters for up to 12 years. Material and Methods: In a registry study of men with hypogonadism in a urological office, 676 of 805 patients (84%) had hypertension defined as systolic blood pressure (SBP) ≥130 and/ or diastolic blood pressure (DBP) ≥85 mmHg according to the harmonized definition of the metabolic syndrome. 376 received testosterone therapy (TTh) with TU 1000 mg/12 weeks following an initial 6-week interval (T-group). 304 had opted against TTh and served as controls (CTRL). 10-year data are reported. Changes over time between groups were compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction, and adjusted for age, weight, waist circumference, fasting glucose, blood pressure and lipids to account for baseline differences between groups. Results: Mean (median) follow-up: T-group 7.7±2.6 (9), CTRL 8.1±2.1 (9) years. Total observation time: T-group 2900, CTRL 2463 years. Baseline age was 58.5±6.8 (T-group) and 63.8±4.8 years (CTRL). In the T-group, 189 men were and 187 were not aware of their hypertension at their first visit to the urologist, in CTRL, 139 and 161, respectively. Antihypertensives were used by 52.7% in T-group and 46.7% in CTRL. All patients were encouraged to improve their lifestyle at baseline. SBP decreased in the T-group by 23.6±0.7mmHg [95% CI: -24.9;-22.3] (p

Background: Quality of life in men is influenced by general health, sexual function and urinary function. These components are associated with both weight and inflammatory status. Material and Methods: 805 men with hypogonadism are enrolled in a registry study in a urological office. 412 received TTh with TU 1000 mg/12 weeks (T-group) while 393 opted against TTh and served as controls (CTRL). 43 men (10.4%) in the T-group had Klinefelter’s syndrome and contributed to lowering the mean age of the treated group. Measurements were performed 1-4 times a year. 10-year data are reported. Changes over time between groups were compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction, and adjusted for age, weight, waist circumference, fasting glucose, blood pressure and lipids to account for baseline differences between groups. Results: Baseline age: 57.7±7.4 (T-group), 63.7±4.8 years (CTRL). Mean (median) follow-up: 8 (8) years (T-group) and 8 (9) years (CTRL). Total observation time: 6471 patient-years. The Aging Males’ Symptoms scale (AMS) decreased by 29.2±0.3 (p

Objective: The association between erectile dysfunction (ED), hypogonadism, cardiovascular disease, and type 2 diabetes is well documented, but long-term data are limited. The aim of this study is to investigate effects of long-term testosterone therapy (TTh) with testosterone undecanoate in men with hypogonadism and ED.Patients and methods: Observational, prospective registry of 805 hypogonadal men with different degrees of ED, evaluated by the International Index of Erectile Function - Erectile Function Domain. Four hundred and twelve patients underwent TTh, 393 patients served as controls, with an observation period up to 12 years.Results: TTh led to substantial and sustained reduction of ED; improvement in erectile function was significant for each successive year until year 9. This was accompanied by improvements in cardiometabolic risk factors and urinary function throughout the 12-year follow-up period. Benefits of TTh were stronger for patients with moderate/severe ED than for patients with no/minor ED. Incidence of prostate cancer, major adverse cardiovascular events, and mortality were significantly lower in men on TTh compared with untreated men.Conclusion: Long-term TTh for up to 12 years alleviates ED, improves cardiometabolic risk factors, and reduces prostate cancer. Patients must stay on TTh consistently for a long time to achieve maximum benefits of TTh.

For obese type 2 diabetes patients, weight reduction is one of the most important measures but fails in most cases. Testosterone deficiency can be the reason for such failure. This case presents a 57-year-old man who was referred to a urologist due to benign prostatic hyperplasia and erectile dysfunction. He had type 2 diabetes, was overweight, and had hypertension and dyslipidemia. The blood test revealed testosterone deficiency. Under testosterone therapy, the patient lost 10 kg; cardiometabolic parameters returned to normal and lower urinary tract symptoms disappeared; complete remission of diabetes was recorded. Overweight and obese patients with type 2 diabetes should be tested for hypogonadism and testosterone therapy, if indicated, be considered. These patients can considerably benefit from testosterone therapy in terms of sustainable weight loss and a clinically significant reduction of cardiometabolic risk factors including complete remission of diabetes.

Background: Hypogonadism is highly prevalent in men with T2DM. Methods: Of 805 hypogonadal men in a urological registry, 311 men (39%) had T2DM diagnosed and treated elsewhere. 141 received TU 1000 mg/12 weeks (T-group), 170 opted against treatment (CTRL). Mean changes over time between groups were compared by mixed effects model. Changes were adjusted for age, weight, waist circumference, HbA1c, blood pressure (BP), lipids to account for baseline differences between the two groups. Results: Mean follow-up 7.5 years for 2.319 patient-years. Age: 62.8±5.1 years. T-group: HbA1c progressively decreased from 9.0±1.2 to 5.9±0.3% at 10 years (p Conclusions: Long-term TTh with TU in hypogonadal men with T2DM improved diabetic measures and reduced MACE compared to untreated controls. Disclosure F. Saad: Employee; Self; Bayer AG. Stock/Shareholder; Self; Bayer AG, Novo Nordisk A/S. K.S. Haider: Other Relationship; Self; Bayer AG. A. Haider: Research Support; Self; Bayer AG.

Background: Hypogonadism is highly prevalent in men with obesity as well as T2DM. Methods: Of 805 hypogonadal men in a urological registry, 311 men (39%) had T2DM diagnosed and treated elsewhere. 141 received TU 1000 mg/12 weeks (T-group), 170 opted against treatment (CTRL). Mean changes over time between groups were compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction. Changes were adjusted for age, weight, waist circumference, HbA1c, blood pressure (BP), lipids to account for baseline differences between the two groups. Results: Mean age:T-group: 61.8±5.3, CTRL: 63.5±4.9 years. Follow-up: mean: 7.5, median: 8 years. T-group: 89.4% were obese, 9.9% overweight, and 0.7% had normal weight. Weight decreased progressively from 113.4±13.9 to 90.7±8.6 kg at 10 years (p Conclusions: Long-term TTh with TU in hypogonadal men with T2DM improved anthropometric measures compared to untreated controls. Disclosure F. Saad: Employee; Self; Bayer AG. Stock/Shareholder; Self; Bayer AG, Novo Nordisk A/S. K.S. Haider: Other Relationship; Self; Bayer AG. A. Haider: Research Support; Self; Bayer AG.

Background: Hypogonadism predicts T2DM and is highly prevalent in men with prediabetes. Methods: Pooled data from 2 ongoing urological registries. 303 men had prediabetes by HbA1c according to ADA definition. 220 received treatment with 3-monthly injections of testosterone undecanoate (TU; T-group), 83 served as controls (CTRL). Anthropometric and metabolic parameters were measured over 8 years. Results: Mean follow-up: 6.6 years (T-group), 5.6 years (CTRL). Mean age: 60.6±9.6 years. Under TU, HbA1c decreased from 5.9±0.2 to 5.5±0.3% at 8 years (p6.5% The TyG index, a surrogate parameter for insulin resistance, decreased in the T-group from 9.3±0.4 to 9.0±0.4 at 8 years. In CTRL, the index increased from 8.9±0.6 to 9.3±0.4 at 8 years. At baseline, 158 men (52.1%) were obese, 126 men (41.6%) were overweight and 19 (6.3%) had normal weight. Weight decreased from 96.7±12.3 to 89.0±9.6 kg in the T-group and increased from 92.9±10.4 to 98.2±6.3 kg in CTRL. Waist circumference decreased from 104.2±7.1 to 98.2±6.5 cm in the T-group and increased from 102.5±9.7 to 106±3.2 cm in CTRL. Weight loss was 9.2±8.3% at 8 years in the T-group. In CTRL, weight increased by 9.2±3.9% at 8 years (p Conclusion: Testosterone therapy prevented progression from prediabetes to T2DM in hypogonadal men while more than 40% of untreated hypogonadal men developed T2DM. This effect may have been supported by sustained weight loss and been mediated by the invariable increase in lean mass achieved by testosterone. Disclosure F. Saad: Employee; Self; Bayer AG. Stock/Shareholder; Self; Bayer AG, Novo Nordisk A/S. A. Haider: Research Support; Self; Bayer AG. K.S. Haider: Other Relationship; Self; Bayer AG.

Background: According to 2016 AACE/ACE obesity guidelines, hypogonadism should be assessed and treated in indicated in men with type 2 diabetes mellitus (T2DM). Methods: In a registry of hypogonadal men (testosterone ≤12.1 nmol/L) conducted since 2004 in a urological setting, 133/400 patients (33.3%) had T2DM diagnosed and treated in a diabetes center. All men received testosterone undecanoate (TU) injections 1000 mg/12 weeks (T-group) following an initial 6-week interval. Anthropometric and metabolic parameters were measured at least twice a year and fasting insulin obtained from the diabetes center to calculate HOMA-IR. Results: Mean follow-up was 6.9, maximum 11 years. 16 patients (12%) were in remission at the last measurement. Their average baseline age was 60.1 years. HbA1c dropped from 8.3% at baseline to 5.7% at the last measurement, fasting glucose from 7.8 mmol/L to 5.4 mmol/L. Fasting insulin declined from 24.7 to 7.6 µU/mL. HOMA-IR dropped from 8.7 to 1.8. Triglycerides decreased from 3.2 to 2.2 mmol/L. Anthropometric parameters: Body weight declined progressively from 107 to 89 kg, waist circumference from 1to 97 cm. All patients had been on oral antidiabetic medication (metformin) at baseline. Five patients were on insulin at an average dose of 21.6 units per day. The average observation time was 106.3 months (8.9 years). The average time to discontinuation of diabetes medication was 74.8 months (6.2 years). One patient was diagnosed with low-grade prostate cancer and developed new onset T2DM while off TU. He went into remission 48 months after resuming TU therapy. Medication adherence to TU was 100 per cent as all injections were administered in the urology office and documented. Discussion: The registry was not designed to study the effects of testosterone on T2DM. Remission of T2DM has not been described in the literature and was unexpected. Conclusions: Long-term testosterone treatment in hypogonadal men may result in remission of T2DM. Disclosure A. Haider: Research Support; Self; Bayer AG. K.S. Haider: Other Relationship; Self; Bayer AG. F. Saad: Employee; Self; Bayer AG. Stock/Shareholder; Self; Bayer AG, Novo Nordisk A/S.

Although prostate cancer (PCa) screening is conducted before testosterone replacement therapy (TRT), clinically occult PCa cases may exist. To evaluate whether the possible inclusion of occult PCa cases distorts the effect of TRT on risk of PCa, we followed 776 hypogonadal males (TRT = 400, non-TRT = 376) from a urology center in Germany from 2004 to 2016, with a mean follow-up period of 7 years. We assumed occult cases might take 1–2 years (latency period) to become clinically detectable after receiving TRT. We selected several latency periods (12/18/24 months) and compared the risk of PCa in the TRT and non-TRT group over the latency period, from the end of latency period till the end of follow-up, and over the whole follow-up time. Overall, 26 PCa cases occurred in the non-TRT group vs 9 cases in the TRT group. Within 18 months of follow-up, 9 cases occurred in the TRT group vs 0 cases in the non-TRT group; from the end of 18 months till the end of follow-up, 26 cases occurred in the non-TRT group vs 0 cases in the TRT group. The adjusted table showed seemingly adverse effects of TRT on PCa development within 18 months (p = 0.0301) and beneficial effects from the end of 18 months till the end of follow-up (p = 0.0069). Similar patterns were observed for 12 or 24 months as the latency period. TRT may make occult PCa cases detectable within early phase of treatment and present a beneficial effect in the long run. Future longitudinal studies are needed to confirm findings from our exploratory analyses.

We investigated whether dynamic patterns of testosterone levels contribute to risk of prostate cancer.We used data on 376 untreated men with hypogonadism (testosterone 12.1 nmol/l or less) recruited from a urology office in Germany. Age at study entry served as a surrogate for age at the first detection of testosterone below 12.1 nmol/l. We derived 3 indicators, including the coefficient of variation, the ratio of the largest decline relative to the mean and the median of maximum declines, to measure the dynamic patterns of testosterone in an individual.Our findings suggest that the later that testosterone dropped below 12.1 nmol/l in a man, the less the lifetime risk of prostate cancer in that individual (HR 0.68, 95% CI 0.57-0.82). Further declines or dynamic variations of testosterone were associated with increased risk of prostate cancer (high vs low coefficient of variation HR 4.88, 95% CI 1.97-12.08, high vs low ratio of largest decline relative to mean HR 8.45, 95% CI 2.82-25.37 and high vs low median of maximum declines HR 2.70, 95% CI 1.15-6.35).To our knowledge this study is the first to provide evidence of the association between dynamic patterns of testosterone and prostate cancer development. This may have substantial clinical impacts on prostate cancer prevention.

Background Dutasteride has been successfully used in treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). However, dutasteride inhibits 5α-reductase type 1 and type 2 enzymes and may compromises glucocorticoids and androgen metabolism and alters metabolic function resulting in undesirable metabolic and sexual adverse side effects. Aim The aim of this study was to investigate the long-term adverse effects of dutasteride therapy in men with BPH on: i) blood glucose, ii) glycated hemoglobin (HbA1c), iii) low density lipoprotein-cholesterol (LDL-C); high density lipoprotein-cholesterol (HDL-C) and total cholesterol (TC), iv) testosterone (T), v) liver alanine and aspartate aminotransferases (ALT and AST) and vi) erectile dysfunction (ED). Methods A retrospective registry study, with a cohort of 230 men aged between 47 and 68 years (mean 57.78 ± 4.81) were treated with dutasteride (0.5 mg/day) for LUTS, secondary to BPH. A second cohort of 230 men aged between 52 and 72 years (mean 62.62 ± 4.65) were treated with tamsulosin (0.4 mg). All men were followed up for 36-42 months. At intervals of 3-6 months, and at each visit, plasma glucose, HbA1c, TC, LDL-cholesterol, T levels and liver alanine amino transferase (ALT) and aspartate aminotransferase (AST) were determined. Further patient assessment was made by the International Index of Erectile Function (IIEF-EF) questionnaire, the Aging Male Symptom (AMS) and International Prostate Symptom Scores (IPSS). Results Long-term treatment with dutasteride therapy is associated with significant improvements in LUTS, as assessed by reduction in prostate volume, IPSS and prostate specific antigen (PSA). Long-term dutasteride therapy, however, resulted in increased blood glucose, HbA1c, TC and LDL levels, ALT and AST activities, AMS Score and reduced T levels and worsened ED as assessed by the IIEF-EF scores. No worsening of ED, glucose, HbA1c, ALT, AST, AMS were observed in men treated with tamsulosin. Most importantly, long-term dutasteride therapy resulted in reduction in total T levels, contributing to a state of hypogonadism. Conclusion Our findings suggest that long-term dutasteride therapy produces worsening of ED, reduced T levels and increased glucose, HbA1c and alters lipid profiles, suggesting induced imbalance in metabolic function. We strongly recommend that physicians discuss with their patients these potential serious adverse effects of long-term dutasteride therapy prior to instituting this form of treatment.

INTRODUCTION AND OBJECTIVES:ED is a predictive risk factor for CVD. We monitored effectiveness and safety of long-term Testosterone Therapy (TTh) in hypogonadal men with a history of CVD.METHODS:Two observational registry studies of 622 hypogonadal men from two urological centers: 77 men with a previous diagnosis of coronary artery disease (CAD; n=48) and/or a myocardial infarction (MI; n=40) and/or stroke (n=7) received TU for up to 14 years.RESULTS:Mean age was 60.65 ± 4.98 years, mean follow-up time was 7.29 ± 1.20 years. Testosterone (T) levels rose from 9.78 ± 1.56 nmol/L to trough levels (measured prior to the following injection) between 16 and 18 nmol/L. IIEF-EF (maximum score: 30) increased from 19.64 ± 6.34 to 24.49 ± 4.69 with a change from baseline of 5.37±0.36, this improvement was statistically significant for the first three years and remained statistically significant vs baseline throughout the observation time and stable compared to previous years.Weight decreased progressively from 114.4...