Aging Male Symptoms Research Articles

Correlation between serum P450arom and sex hormones in males with late-onset hypogonadism: a pilot study.

The research aimed to investigate the correlation between serum P450arom and sex hormones in males with late-onset hypogonadism (LOH). A total of 97 LOH patients and 301 matched healthy males of same age underwent androgen deficiency in the aging males (ADAM) and aging males' symptoms (AMS) scales as well as basic questionnaire survey. Serum P450arom, sex hormones, fasting blood glucose and lipid profiles were tested. General information, P450arom and sex hormone levels were compared between the LOH group and the control group. Pearson correlation analysis was used to analyze the correlation between serum P450arom concentration and AMS score, blood glucose, lipid profiles, body mass index (BMI) and sex hormones. Compared with the control group, the fasting blood glucose, body mass index (BMI), and Estrogen/Total Testosterone ratio (E2/TT) were significantly increased in LOH group (p<0.05), while TT, E2 and testosterone secreting index (TSI) were significantly decreased (p<0.05). No significant difference in P450arom concentration was observed between the two groups (p>0.05). The serum P450arom concentration was not related to TT, E2/TT, AMS score, and BMI. These findings suggested that the serum P450arom concentration is unrelated to LOH symptom score and sex hormone levels and could not be used as an observation index and diagnostic basis for LOH.

Long-term safety, health and mental status in men with vasectomy

Vasectomy is an efficient male contraceptive method, but the long-term effects of this technology in a large population are unclear. To investigate the influence of vasectomy on long-term health effects, we recruited 485 men with a vasectomy and 1940 men without vasectomy in China. After obtaining basic information from the Aging Males’ Symptoms (AMS) scale and other questionnaires, peripheral blood was drawn to assess the hormone levels, prostate specific antigen (PSA) and blood biochemistry. Using multiple linear regression analysis, these factors had no relationship with vasectomy except for four factors including the Somatic score (0.31, 0.02 and 0.61) in AMS, SF-36 score (−18.8, −32.00 and −5.60), “Role emotional” (−6.28, −10.34 and −2.22) and “Mental health” (−1.55, −3.08 and −0.02). A stratified analysis showed that with increased age, smoking and drinking, residence in township or a higher level of education, the mental health of men was worse. Vasectomy had no long-term effect on the level of sexual hormones in men, and it did not increase the level of PSA. The impact of the vasectomy on quality of life in men were mainly reflected in psychological effects, which suggests that men with vasectomy groups many benefit from professional psychological counseling.

A Randomized Controlled Double-Masked Study of Transdermal Androgen in Dry Eye Patients Associated With Androgen Deficiency

To evaluate the efficacy, safety, and quality of life (QOL) of transdermal androgen in treatment of dry eye patients associated with androgen deficiency. Randomized controlled trial. Fifty patients with dry eye from a tertiary eye center in northern Thailand were randomized to receive transdermal androgen (AndroGel; Besins Healthcare, Brussels, Belgium) or placebo for 4weeks. Main outcome measures were symptoms and signs of dry eye. Serum level of sex hormone and QOL questionnaires were also evaluated at the baseline and after treatment. After 4weeks, the Ocular Surface Disease Index decreased significantly in the AndroGel group compared to the placebo (-14.36 ± 7.76 vs 0.14 ± 14.60, P < .001). Significant improvements of tear break-up time (7.40 ± 3.37 vs-1.14 ± 1.68 seconds, P < .001), corneal fluorescein staining (-0.62 ± 0.30 vs 0.19 ± 0.37, P < .001), and Schirmer test (6.84 ± 5.10 vs-0.48 ± 2.14mm, P < .001) were observed in the AndroGel group compared to the placebo. Serum testosterone in female patients significantly increased in the AndroGel group compared to the placebo (P < .001), while no different change was observed in serum testosterone in male subjects and the sex hormone-binding globulin in both groups. In the AndroGel group, 20% of patients had oily skin and 4% had acne. No serious adverse effects were reported. The menopause rating score improved significantly in the AndroGel group compared to the placebo (P < .001), while the aging male symptoms were not different in both groups (P= .589). Transdermal androgen was effective in relieving symptoms and signs of dry eye as well as improving QOL in aging patients. There were no serious side effects during a short-term treatment.

Oral L-citrulline and Transresveratrol Supplementation Improves Erectile Function in Men With Phosphodiesterase 5 Inhibitors: A Randomized, Double-Blind, Placebo-Controlled Crossover Pilot Study.

IntroductionPhosphodiesterase type 5 inhibitors (PDE5i) are first-line therapy for most men with erectile dysfunction (ED). If ineffective, vacuum erection devices, intracavernous injections, and penile prosthesis implantation are suitable as second- or third-line therapies. However, very few patients select these therapies. It is critically important to improve erectile function with oral administration of effective agents. Administration of L-citrulline or transresveratrol in animal experiments has been reported to improve erectile function, but few such experiments have been performed on humans with ED.AimWe aimed to investigate the efficacy of combination therapy of L-citrulline and transresveratrol in patients with ED despite their use of PDE5i.MethodsIn this randomized, double-blind, placebo-controlled crossover pilot study, men with ED (Sexual Health Inventory for Men [SHIM] score below 16) despite on-demand use of PDE5i received a placebo for 1 month or the active treatment (L-citrulline 800 mg/day and transresveratrol 300 mg/day) for another month. Patients continued on-demand use of PDE5i.Main Outcome MeasureThe SHIM score, Erection Hardness Score (EHS), Aging Male Symptoms Scale-sexual domain (AMS-SD), and adverse events were examined.Results20 patients ages 29–78 years were enrolled, and after 6 men withdrew, 13 concluded the study without adverse events. Mean SHIM score for the active treatment increased significantly (10.96 ± 1.21) compared with baseline (8.32 ± 1.21) and placebo (8.31 ± 1.23) (both P < .05). Mean EHS score for the active treatment (2.56 ± 0.26) also increased from baseline (2.31 ± 0.26), but not significantly (P = .79). Mean AMS-SD score was not significantly different in either group.ConclusionTo our knowledge, this is the first study to show that combination therapy of L-citrulline and transresveratrol is effective for ED treatment in men with added on-demand use of PDE5i. This combination supplement may be added if PDE5i is insufficient.Shirai M, Hiramatsu I, Aoki Y, et al. Oral L-citrulline and Transresveratrol Supplementation Improves Erectile Function in Men With Phosphodiesterase 5 Inhibitors: A Randomized, Double-Blind, Placebo-Controlled Crossover Pilot Study. Sex Med 2018;6:291–296.

Effect of testosterone replacement therapy on sexual function and glycemic control among hypogonadal men with type 2 diabetes mellitus.

We investigated the effect of testosterone replacement therapy (TRT) on glycemic control and sexual function among hypogonadal men with type 2 diabetes mellitus (T2DM). From the EARTH study, 86 patients (47 in the TRT and 39 in the non-TRT groups) with a diagnosis of T2DM were extracted. We collected data on waist circumference, body mass index, body fat volume, free testosterone, hemoglobin (Hb), fasting blood sugar, and hemoglobin A1c (HbA1c) at baseline and after 12 months. Aging Male Symptoms (AMS) score and International Prostate Symptom Score were obtained. Sexual function was assessed by questions 15 (sexual ability), 16 (morning erections), and 17 (sexual desire) of AMS subscores. The TRT group received intramuscular testosterone enanthate (250 mg) injections every 4 weeks for 12 months. Body fat percentage, Hb, and HbA1c were significantly improved in the TRT group. In addition, sexual ability and frequency, and sexual desire showed a significant improvement in the TRT group after 1 year TRT. On the other hand, any parameters including glycemic control and sexual functions were not significantly improved in non-TRT groups. One-year TRT can improve sexual function and glycemic control among hypogonadal men with T2DM.

Association Between Serum Testosterone and Serum PSA Among Men With and Without Partial Androgen Deficiency.

Serum prostatic specific antigen (PSA) and serum testosterone levels share an undefined relationship with each other, with many conflicting studies showing both positive and negative correlation between them. Our aim was to assess association between serum PSA and serum testosterone in healthy men with normal testosterone levels and men with partial androgen deficiency (PADAM). A cross sectional study was conducted at a teaching hospital setting where serum testosterone and aging male symptom scale(AMS) scores along with PSA were studied in 255 men (> 50years) with and without PADAM. Mean total testosterone and serum PSA was 9.35 ± 1.33nmol/L, 1.96 ± 0.76ng/mL in males with PADAM and 15.30 ± 1.95nmol/L, 1.85 ± 0.73ng/mL respectively in males without PADAM. No significant relationship was observed between serum PSA and serum testosterone levels among healthy males irrespective of PADAM in the study population. We suggest, there is no need to adjust PSA values for biopsy decisions according to testosterone levels.

603 Clinical trial with natural extracts from Lycium chinense for eugonadal men with late-onset hypogonadism-related symptoms: placebo-control, double-blind, randomized study

The purpose of this study was to evaluate the efficacy and safety of natural extracts from Lycium chinense on eugonadal men with late-onset hypogonadism(LOH)-related symptoms. Seventy-eight eugonadal men over 40 years of age with LOH-related symptoms were included in this study, and divided into two groups: treatment group and placebo-control group. Treatment was given orally to these patients three times daily for two months. Laboratory and endocrinological profiles were reviewed, and LOH symptoms were judged by means of several health assessment instruments such as the Aging Males’ Symptoms (AMS) scale. All patients represented no significant differences in vital sign, liver and kidney profile, urinalysis. In total score of AMS scale, placebo group had no significant change in mean score after treatment, but treatment group had decreased their score about 2.63 at 4 weeks and 2.69 at 8 weeks. (p=0.019, 0.038). In AMS subscale analysis, there were no significant differences in psychological and somatic subscale but significant decreased about 1.07 score at sexual subscale in treatment group. Lipid profiles were no definite changes between two groups and also in pre-treatment and post-treatment. PSA and serum testosterone level changes shows no significant difference between two groups.

302 Stimulating hormone therapy in the treatment of age related hypogonadism

Androgen replacement therapy has proved to be standard approach for aging male testosterone deficiency. But it has a number of disadvantages and side effects such as infertility, huge variation in testosterone levels, discomfort because of administration form (gel: skin reaction; intra-muscular injections: pain), by-passing natural endogenous source of androgens (Leydig cells) and risk of gynecomastia . In this study we report our experience using stimulating hormone therapy (human chorionic gonadotropin) to treat age related hypogonadism. As of October 2015 75 patients with age related hypogonadism (diagnosis criteria: low total testosterone 8.0 -12,0 nmol/l, symptoms of low testosterone (AMS >30) and documented erectile dysfunction (ED) by IIEF≤15) were included in a study to investigate the effect of hHG therapy (1500 IU) by subcutaneous injection. Treatment was administered 2 times/week during 3 months. Mean age was 55,4+2,3 (49-62 years). Prostate volume, prostate-specific antigen (PSA), hormonal level (T, LH), biochemical lipid spectrum, aging male symptoms (AMS), International Index of erectile function – erectile function (IIEF-EF) and International Prostate Symptoms Scores (IPSS) were measured over the study period and percentage of change from baseline were calculated. Treatment was began after determination of testicular reserve function, which consisted in 3 hCG injections(1500 IU ) and serum T control. The result was considered as positive in case of the 2 fold T serum level increases.

589 Efficacy and safety of low dose testosterone ointment therapy for late-onset hypogonadism patients

There are several testosterone replacement therapy (TRT) methods for late-onset hypogonadism (LOH), including oral, injection, trans-dermal, etc. However, only TRT with injection (testosterone enanthate) or short-acting ointment (Glowmin: GL) are available for LOH patients in Japan. Our previous report revealed that 3 mg of a short-acting testosterone ointment elevated serum testosterone levels within the physiological range for 4 to 6 hours. The aim of this study was to clarify clinical efficacy and safety of GL once every morning, which would enhance a circadian rhythm of testosterone. Each Institutional Review Board (IRB) approved this prospective clinical study and informed consents had been obtained from 61 LOH patients. These 61 LOH patients received 3 mg of GL once daily in the morning on scrotal skin and the clinical efficacy of GL were estimated by aging male symptoms (AMS) score at 4, 12 and 24 weeks after GL administration. Blood sampling tests including serum hormone levels, hemoglobin, liver and real functions, lipids, blood sugar and prostate specific antigen were compared before and 12, 24 weeks after GL treatment.

Female sex hormones in men with migraine.

To assess the role of estradiol and testosterone in men with migraine. We measured 17β-estradiol (E2) and calculated free testosterone (Tf) in serum of 17 medication-free men with migraine and 22 men without migraine group-matched for age and body mass index (BMI), targeted at 20 to 28 kg/m2. Blood was sampled on a single, for migraineurs interictal, day at 9 am, 12 pm, 3 pm, and 6 pm. Migraineurs were subsequently measured 3 to 4 times daily until an attack occurred. Clinical androgen deficiency was assessed with the Androgen Deficiency of Ageing Men questionnaire and the Aging Males' Symptoms (AMS) scale. We analyzed interictal data (mean ± standard error) with repeated-measures analysis of covariance and longitudinal data by generalized estimated equations models. Compared to controls, men with migraine had a lower interictal Tf/E2 ratio (3.9 ± 0.4 vs 5.0 ± 0.3, p = 0.03) due to higher E2 (96.8 ± 6.1 vs 69.1 ± 5.6 pmol/L, p = 0.001) and similar Tf (357.5 ± 21.4 vs 332.6 ± 18.7 pmol/L, p = 0.35) levels. Preictal Tf levels were increased in men with migraine reporting premonitory symptoms (p = 0.03). Men with migraine more frequently reported symptoms of androgen deficiency (11 of 18 [61.1%] vs 6 of 22 [27.3%], p = 0.031), which were also more frequently severe (p = 0.006); their age- and BMI-adjusted AMS scores were higher (27.0 ± 1.2 vs 21.0 ± 1.0, p = 0.002). In this study, nonobese men with migraine exhibited increased levels of the sex hormone estradiol and showed clinical evidence of relative androgen deficiency. The role of estradiol in modulating migraine susceptibility and activity in men deserves further investigations.

The efficacy and safety of short-acting testosterone ointment (Glowmin) for late-onset hypogonadism in accordance with testosterone circadian rhythm

Introduction: It is well known that there is a reduction of circadian rhythm in blood testosterone levels with aging. Our previous report revealed that 3 mg of short-acting testosterone ointment (Glowmin: GL) elevated serum testosterone levels to within the physiological range for 4–6 h. The aim of this study was to clarify the clinical efficacy and safety of GL used topically once every morning, to enhance the circadian rhythm of testosterone, for late-onset hypogonadism (LOH).Methods: A total of 61 LOH patients received 3 mg of GL topically once a day in the morning on scrotal skin for 24 weeks. The clinical efficacy of GL was evaluated by the aging males symptoms (AMS) scale, and blood sampling tests were measured before and after GL treatment.Results: Mean patients age was 55.3 ± 9.2 years old. Total AMS scores at 4, 12, and 24 weeks after GL treatments significantly decreased. The results of sub-analysis of AMS, including psychological, physical, and sexual factors also significantly improved after GL treatments. No severe adverse reactions or abnormal laboratory data were reported.Conclusions: This study shows that TRT for LOH with once daily GL treatment supports testosterone circadian rhythm and should be considered to be an effective and safe therapy for LOH.

Efficacy of Testosterone Treatment in Hemodialysis Patients as Assessed by Aging Males' Symptoms Scores: A Pilot Study.

Numerous reports point to the beneficial effects of testosterone replacement therapy for patients with late-onset hypogonadism (LOH) syndrome. The aim of this study was to evaluate the effect of intramuscular injection of testosterone enantholactam acid ester on Aging Males’ Symptoms (AMS) scores in hemodialysis patients with LOH. A total of 24 male patients with LOH (total AMS scores ≥27) were randomized into groups receiving intramuscular injections of either placebo or testosterone enantholactam acid ester at the dose of 250 mg for 6 months. In all, 13 and 11 participants from the active treatment and placebo groups, respectively, completed this study. An intramuscular injection of either placebo or testosterone enantholactam acid ester was given every 2 weeks. Self-administered AMS questionnaires were completed at the start, at Week 12 and at Week 24. The total AMS score was significantly more improved in the treatment group than in the placebo group (p = .049) during the 24-week period. The change in the mean of total AMS score was +1% in the placebo group and −13.2% in the treatment group. The mean somato-vegetative domain scores decreased significantly only in the treatment group, and not in the placebo group (−1.21 vs. −2.43, p = .028). Although a large-scale study is needed, testosterone treatment may be effective in male patients with hemodialysis who have poor health-related quality of life resulting from LOH.

MOSH Syndrome (Male Obesity Secondary Hypogonadism): Clinical Assessment and Possible Therapeutic Approaches.

Male obesity secondary hypogonadism (MOSH) impairs fertility, sexual function, bone mineralization, fat metabolism, cognitive function, deteriorates muscle mass and alters body composition. The aim of this pilot study was to evaluate the effect of dietary intervention and physical activity on the MOSH patient’s hormonal profile after a 10% weight loss compared to baseline. Fourteen male patients were enrolled. Hormonal, lipid, glycemic profiles and body composition were determined at baseline and after a 10% weight loss. Aging Male Symptoms Scale (AMS) and Yale Food Addiction Scale (YFAS) were administered to patients in order to investigate hypogonadal symptoms and food addiction. Compared to baseline, a significant increase of Total Testosterone (TT) (300.2 ± 79.5 ng/dL vs. 408.3 ± 125.9 ng/dL, p = 0.002, 95% CI 26.8; 167.7) and a reduction of 17-Beta Estradiol level (48.3 ± 14.9 pg/mL vs. 39.2 ± 15.2 pg/mL, p = 0.049, 95% CI 3.1; 0.0) were observed. Total Fat Mass (FM) percentage, android and gynoid fat mass percentage (39.2 ± 6.4% vs. 36.2 ± 5.8%, p = 0.0001, 95% CI 22.5; 62.3; 51.5 ± 6.8% vs. 47.6 ± 6.8%, p = 0.001, 95% CI 0.6; 1.8, vs. 39.2 ± 6.2% vs. 36.5 ± 6.3% p = 0.0001, 95% CI 0.9; 2.0 respectively) were significantly decreased after nutritional intervention. In addition, total Fat Free Mass (FFM) in kg was significantly reduced after 10% weight loss (62.3 ± 2.8 kg vs. 60.3 ± 7.7 kg, p = 0.002, 95% CI 45.0; 93.0). Lifestyle changes, specifically dietotherapy and physical activity, induce positive effects on hypogonadism due to obesity.

MP74-05 SERUM PSA AS A PREDICTOR OF SYMPTOMATIC HYPOGONADISM PARTICULARLY IN RELATION TO PSYCHOLOGICAL SYMPTOMS

You have accessJournal of UrologySexual Function/Dysfunction: Evaluation II1 Apr 2018MP74-05 SERUM PSA AS A PREDICTOR OF SYMPTOMATIC HYPOGONADISM PARTICULARLY IN RELATION TO PSYCHOLOGICAL SYMPTOMS Kazuhito Matsushita, Akira Tsujimura, and Shigeo Horie Kazuhito MatsushitaKazuhito Matsushita More articles by this author , Akira TsujimuraAkira Tsujimura More articles by this author , and Shigeo HorieShigeo Horie More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.2389AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES We often see low levels of PSA in men with symptomatic hypogonadism (HG). The relationship between serum PSA and testosterone level is still controversial. According to the saturation hypothesis, a significant relationship is apparent only in the low testosterone range. We hypothesized that PSA might represent a surrogate marker for symptomatic HG. METHODS Patients presenting to our academic men′s health clinic reported hypogonadal symptoms using the Aging Male′s Symptoms (AMS) scale which grades each hypogonadal symptom on a 5-point Likert scale. Several hormonal and biochemical parameters were measured the same day the survey was completed. The clinical values of total and free testosterone, and PSA for the detection of severe HG were compared using receiver operating characteristic (ROC) curves. Furthermore, relationships between each of the three AMS subscales (psychological, somatic, sexual) and the biochemical parameters were investigated. RESULTS 759 men were included for analysis (mean age=51y±10). At baseline, mean AMS scale was 43±12, mean total testosterone (TT) was 5.01±1.95 ng/mL, mean free testosterone (FT) was 9.53±3.9 pg/mL, and mean PSA was 1.07±0.64ng/mL. We tested the efficacy of PSA, TT, and FT in detecting severe HG, defined as AMS score ≥50. ROC curve analysis for PSA showed an accuracy (area under the curve, AUC) of 0.649±0.033 (p<0.01) in predicting severe HG. When a threshold of 0.7 ng/mL was chosen, sensitivity and specificity for severe HG was 70.1% and 52.8%, respectively. ROC curve analysis for TT and FT showed an AUC of 0.543 (p=0.229) and 0.554 (p=0.126), respectively. When the AMS scale was divided into the three subscales, psychological and somatic factors, while marginal, showed significant correlation with PSA. Multivariable analysis showed that only psychological factor was significantly associated with PSA levels (p=0.013). CONCLUSIONS Our data demonstrated that PSA levels were more accurate for the prediction of severe HG compared to testosterone levels. It was found that psychological factors were more strongly correlated than sexual factors. These results suggest that low PSA levels may represent a new marker for detecting severe HG. © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e1001-e1002 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Kazuhito Matsushita More articles by this author Akira Tsujimura More articles by this author Shigeo Horie More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

The Effect of Testosterone Replacement Therapy on Penile Hemodynamics in Hypogonadal Men With Erectile Dysfunction, Having Veno-Occlusive Dysfunction.

Hypogonadism may cause veno-occlusive dysfunction (VOD) by structural and biochemical alterations in the cavernosal tissue. The aim of the study was to investigate the effect of testosterone replacement therapy (TRT) on penile hemodynamics in hypogonadal men with erectile dysfunction and VOD.The study included 32 hypogonadal men with erectile dysfunction, having VOD. All patients underwent penile color Doppler ultrasonography (PCDU) at the beginning and 6 months after the initial evaluation. Erectile function was evaluated with the 5-item version of the International Index of Erectile Function (IIEF-5); hypogonadism was evaluated by testosterone measurement and the Aging Male Symptoms (AMS) scale. All patients received transdermal testosterone 50 mg/day for 6 months. Clinical and radiological findings were compared before and 6 months after the TRT.The mean age was 58.81 ± 4.56 (52–69) years. Mean total testosterone levels were 181.06 ± 39.84 ng/dL and 509.00 ± 105.57 ng/dL before and after the therapy, respectively (p < .001). While all patients had physiological serum testosterone levels (>320 ng/dL) after the therapy, three cases (9.3%) had no clinical improvement of hypogonadism symptoms. Cavernosal artery peak systolic velocity (PSV) and resistive index (RI) significantly increased, and end diastolic velocity (EDV) significantly decreased after TRT. VOD no longer existed in 21 (65.6%) of the cases.This study demonstrated that TRT may restore penile hemodynamics in hypogonadal men with VOD.

Фактор роста фибробластов-21 как маркер преждевременного старения мужчин молодого и среднего возраста с сахарным диабетом 2 типа

To investigate the impact of fibroblast growth factor 21 (FGF-21) on the severity of androgen deficiency in young and middle-aged men with type 2 diabetes mellitus. The study comprised 100 men with type 2 diabetes mellitus, cardiovascular multi-morbidity, obesity and androgen deficiency (study group) and 20 healthy men aged 35-50 years. The study group was further divided into two subgroups. Patients of the subgroup 1 received the standard treatment for type 2 diabetes and cardiovascular disease. Patients of the subgroup two were treated with conventional therapy concurrently with testosterone undecanoate. The baseline examination included the following parameters: glycated hemoglobin, total testosterone, prolactin, thyroid stimulating hormone and blood FGF-21. At nine months after the treatment, the blood levels of glycated hemoglobin, FGF21 and testosterone were re-examined. The evaluation of the severity of androgen deficiency was carried out using the ICEF-5 questionnaire and the Aging Males Symptoms scale (AMS). In the study group, the mean FGF-21 level was 2.7 times higher, and the total testosterone level was 2-2.5 times lower than in the control group (p<0.05). A negative correlation was found between the blood levels of FGF-21 and total testosterone (r=-0.41, p<0.05). At nine months post treatment, the subgroup with testosterone undecanoate administered as add-on therapy showed a further decrease in FGF-21 levels and improved androgen deficiency symptoms. FGF-21 is one of the markers for type 2 diabetes, cardiovascular multi-morbidity, obesity and androgen deficiency. Given the association of FGF-21 with androgen deficiency, it can be assumed that FGF-21 plays a role in premature aging. Treatment of androgen deficiency as add-on therapy to the standard treatment of this category of patients improves their prognosis and the quality of life. Young and middle-aged men with type 2 diabetes should undergo regular screening for androgen deficiency with the purpose of its early diagnosis and timely treatment. The detection of elevated levels of FGF-21 in young and middle-aged men with type 2 diabetes mellitus and cardiovascular multi-morbidity may indicate premature aging and requires preventive measures.

Abstract PD7-10: Male-GBG54: A prospective, randomised multi-centre phase II study evaluating endocrine treatment with either tamoxifen +/- gonadotropin releasing hormone analogue (GnRHa) or an aromatase inhibitor + GnRHa in male breast cancer patients

Abstract Background Over 90% of male breast cancer (BC) patients (pts) have hormone receptor (HR) positive disease. Until today tamoxifen is considered to be the standard of care in male BC pts. Due to the low incidence of male BC, there is a lack of data regarding efficacy and safety. Therapeutic strategies are extrapolated from the standard of care of female BC. However, no prospectively randomized study in male BC pts has been conducted so far. The Male-GBG54 study is the first prospective, randomized, multicenter trial evaluating the efficacy and safety of different endocrine treatment options in male BC patients. Patients and Methods In the phase II Male-GBG54 trial (NCT01638247), pts were randomized to receive either tamoxifen 20 mg/day per os (p.o.) or tamoxifen 20mg/day p.o. + GnRHa subcutaneous (s.c.) q3m or exemestane 25 mg/day p.o. + GnRHa s.c. for 6 months as (neo)adjuvant or metastatic therapy. Further treatment was conducted as per local guidelines. Primary objective was the suppression of oestradiol in the three treatment arms after 3 months of therapy. Secondary objectives comprised oestradiol suppression after six months, compliance and safety of the three therapies, the level of different steroidal hormones (testosterone, dihydrotestosterone, SHBG, FSH, LH) and osteocalcin in the three arms. Quality of Life was assessed using the Aging Male Symptom Score, International Index of Erectile function and International Prostate Symptom Score. Tissue and blood was collected for translational research. Male BC pts with a Karnofsky Index ≥60%, normal blood lipids, and no history or evidence of prostate cancer were eligible. 14 pts per group were needed for the F-test to have 80% power to detect a difference in mean oestradiol decrease between the three therapeutic groups at the 5% significance level. The final sample size was calculated as 48 patients, as a non-parametric test (Kruskal-Wallis) was chosen in case the oestradiol levels are not normally distributed within the study population. Results Between October 2012 and May 2017, 55 pts were randomized within 24 centers in Germany. 52 pts were included in the adjuvant and 2 pts in the metastatic setting of whom 48 pts were fully evaluable and comprised the analysis set. The median age was 62 years (range 37-83 years). The baseline characteristics were well balanced between the 3 treatment groups. Karnofsky Index ranged from 60%-100%, 36.4% had received prior chemotherapy and 12.7% had HER2-positive BC. The majority had a pT2 (52%), pN0 (58.0%) BC. 3 serious adverse events were reported, none was related to the study treatment. Conclusion This is the first prospective randomized trial worldwide evaluating the impact of three different endocrine treatments in male breast cancer. The therapy was well tolerated without safety signals. At the meeting, final results of the primary and secondary endpoints will be present. Citation Format: Reinisch M, Seiler S, Hauzenberger T, Schmatloch S, Strittmatter HJ, Zahm DM, Thode C, Jackisch C, Furlanetto J, Strik D, Stickeler E, Marmé F, Janni W, Schmidt M, Kamischke A, Rudlowski C, Nekljudova V, von Minckwitz G, Loibl S. Male-GBG54: A prospective, randomised multi-centre phase II study evaluating endocrine treatment with either tamoxifen +/- gonadotropin releasing hormone analogue (GnRHa) or an aromatase inhibitor + GnRHa in male breast cancer patients [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr PD7-10.

Clinical relevance of low androgen to gastroesophageal reflux symptoms.

The aim of this study was to determine the relationships between free testosterone (FT) level and parameters including laboratory data and data from questionnaires and to determine symptoms leading to the detection of late onset hypogonadism (LOH). We retrospectively reviewed medical records of patients in whom serum FT was measured in our hospital. Aging Male Symptoms (AMS) score, self-rating depression scale (SDS) and frequency scale for the symptoms of gastroesophageal reflux disease (FSSG) score were used for questionnaires. A total of 205 patients were included in the analysis (55.2 ± 15.6 years of age, mean ± SD). Among them, 119 patients (58.0%) had an FT level of less than 8.5 pg/mL, which fulfills the diagnostic criterion of LOH syndrome according to the clinical practice manual for LOH in Japan. It was revealed that FSSG score was inversely correlated to serum FT levels (r = -0.3395, p < 0.001), although SDS and AMS scales did not show significant correlations to FT levels. Our study revealed a high prevalence of LOH syndrome among patients in whom the majority complained of general symptoms. Although GERD symptoms are generally not considered to be typical symptoms of LOH, our study indicates that those symptoms might be clues for the detection of LOH.

Examining the effect of the computer-based educational package on quality of life and severity of hypogonadism symptoms in males

Objective: The objective of this study was to determine the effect of the computer-based educational package on men’s QoL and the severity of their hypogonadism symptoms.Methods: A quasi-experimental study was conducted on 80 male employees. The data collection tool included the ‘Aging Male Symptoms’ (AMS) and ‘Short Form-36’ (SF36) questionnaires. Four sessions were held for the intervention group over a period of 4 weeks. Two months after training, QoL and the severity of hypogonadism symptoms were measured in both the intervention and control groups. The data were analyzed with SPSS 22 software and statistical tests, such as χ2, independent t-test, Fisher’s exact test, and paired t-tests.Results: Significant statistical changes were observed in the intervention group before and 2 months after the training in the QoL score in the overall dimensions of physical–psychological health and all its domains except for three domains of emotional role, social function, and pain. Furthermore, the paired t-tests showed significant differences between 2 months before and after the training in all the domains and the overall hypogonadism score in the intervention group.Conclusions: Based on our findings, the computer-based educational package has a positive effect on QoL and reduction of hypogonadism symptoms.

Ageratum conyzoides L. inhibits 5-alpha-reductase gene expression in human prostate cells and reduces symptoms of benign prostatic hypertrophy in otherwise healthy men in a double blind randomized placebo controlled clinical study.

A double-blind, randomized, placebo-controlled clinical trial assessed the efficacy and safety of Ageratum conyzoides in treating benign prostatic hypertrophy (BPH). In this study, 109 men with medically diagnosed BPH, aged 41-76 years, were administered the investigational product, A. conyzoides extract at a dose of 250 mg/d or placebo, q.d. for 12 weeks. The primary outcome measures were the International Prostate Symptom Score (IPSS), daily urinary frequency and safety evaluations. The secondary outcome measures were testosterone, dihydrotestosterone, oestradiol, sex hormone binding globulin (SHBG), Dehydroepiandrosterone sulfate (DHEA-S) and cortisol levels, and prostate specific antigen (PSA), lipids, blood glucose, the Aging Male's Symptom (AMS) Score and sexual function assessed by Derogatis Interview for Sexual Functioning-Self Report (DISF-SR). The effect of A. conyzoides L extract on gene expression of 5-alpha-reductase in human prostate cells was also investigated to elucidate a potential mechanism of action. The clinical study, showed a significant reduction in total IPSS score (p < 0.01) and day- and night-time urinary frequency (P < 0.01) over time after treatment with A. conyzoides. Steroid hormones, SHBG, PSA levels, lipids, and blood glucose remained within healthy reference range in both groups. There were no changes in AMS or DISF-SR in either group. Gene arrays demonstrated that A. conyzoides extract was effective in reducing the expression of mRNA coding for 5-alpha-reductase types 2 and 1 in human prostate epithelial cells. The overall results indicate that A. conyzoides may be an effective treatment for reducing symptoms of BPH in healthy men, in part, through inhibition of 5-alpha-reductase enzyme activity. © 2017 BioFactors, 43(6):789-800, 2017.