Testosterone Levels In Patients Research Articles

(106) Stem Cell Therapy Leads to an Increase in Testosterone Levels in Infertile Men

Abstract Introduction Sexual dysfunction is frequently encountered in infertile males. This may be related to psychosexual aspects of infertility and to some common factors of pathogenesis, such as hypogonadism. For example, many patients with non-obstructive azoospermia (NOA) have low testosterone levels, which may lead to low sex drive, erectile dysfunction and metabolic abnormalities later in life. Patients with NOA typically undergo surgical sperm retrieval procedures, which may lead to further decrease in androgen production, which may be transient or even permanent in some cases. Stem cell therapy is an investigative mode of treatment for patients with NOA, but its influence on Leydig cell function is currently unknown. Objective To assess the impact of stem cell therapy on testosterone levels in men. Methods Sixty patients with NOA were included in this study. All of them underwent unsuccessful MicroTESE more than 12 months prior to the inclusion in order to justify the use of stem cell therapy. Multipotent mesenchymal stromal cells (MMSC) were derived from healthy donor placenta following physiologic childbirth. MMSC product was used for systemic and local treatment via intravenous and intratesticular injection, respectively. Endocrine profiling was performed at baseline and 3 months after the procedure. Results Median testosterone level prior to MMSC therapy was 8.7 nmol/l (interquartile range [IQR]: 4.2–12.1), and 3 months after it was 12.3 nmol/l (IQR: 8.8–16.3) (p < 0.00001). This may be related to an increase in luteinizing hormone levels from 6.4 mIU/ml at baseline (IQR: 3.6–11.3) to 9.6 mIU/ml (IQR: 5.2–14.1) (p = 0.00026). Paradoxically, follicle-stimulating hormone levels declined from 12.5 mIU/ml (IQR: 4.7–24.7) to 7.4 mIU/ml (IQR: 4.2–12.3) (p < 0.00001). Prior to MMSC therapy 43 patients (71.7%) had testosterone levels lower than 12 nmol/l, after MMSC therapy 24 patients (40%) had testosterone levels lower than this threshold. Thirty patients (50%) and 14 patients (23.3%) had testosterone level below 8 nmol/l before and after MMSC therapy respectively. Conclusions MMSC therapy may increase testosterone levels in patients with NOA, though the exact mechanisms and its possible impact on quality of life should be elucidated. Disclosure No.

(123) Postoperative Changes of Serum Total Testosterone Levels in Patients with Prostate Cancer After Robot-Assisted Radical Prostatectomy

Abstract Introduction Although a relationship between prostate cancer and serum total testosterone (TT) has been studied, previous evidences were contradictory. Although a relationship between prostate cancer and serum total testosterone (TT) in terms of cancer biology as well as sexual function has been studied, previous evidences were contradictory and not organized very well. Objective We investigated the changes in TT levels after robot-assisted radical prostatectomy (RARP) for prostate cancer as a prospective surveillance. Methods From July 2015 to January 2022, 290 patients out of 1,343 prostate biopsies performed in our hospital underwent RARP with a diagnosis of localized prostate cancer. TT measurements were performed at 6:00 early morning on admission to all patients for biopsy. Of these, we studied 76 patients whose TT values have been measured during postoperative follow-up. TT values were measured 1 month after RARP, every 3 months until 36 months thereafter, and every 6 to 12 months thereafter for up to 72 months postoperatively. Results The median and quartile of age, serum PSA and TT (pre-TT) values at biopsy of the 76 patients were 69 years (64–72 years), 7.47 ng/mL (5.65–12.74 ng/mL) and 4.03 ng/mL (2.96–4.83 ng/mL), respectively. There was no significant correlation between age and pre-TT values (p = 0.21). RARP was performed an average of 2.9 months after biopsy. The median follow-up period was 43 months (31–60 months). PSA recurrence was observed in 18 patients (23.7%), with 3- and 5-year PSA non-recurrence rates of 77.4% and 74.9%, respectively. There was no significant difference in pre-TT values between patients with or without PSA recurrence (p = 0.107). Analysis of TT values at each observation period after RARP showed relative increase by an average of 23.4% (after 1 month) to 41.6% (after 36 months) when compared with pre-TT values. Further analysis of dividing 76 patients into 2 groups by a pre-TT value of 3.00 ng/mL showed that only in the low pre-TT group (pre-TT < 3.00 ng/mL: 21 cases, 27.6%), the rate of increase in TT values over pre-TT was significantly higher than that in the normal pre-TT group (pre-TT ≥ 3.00 ng/mL: 55 cases, 72.4%) at each observation period up to 72 months after RARP except 33 and 54 months Conclusions The transition of postoperative TT values in the patients who underwent RARP continued to show a significant increase at each observation period only in the group with low TT values preoperatively, suggesting that biochemical hypogonadism may have been presumably caused by prostate cancer-bearing conditions preoperatively in these patients with low TT values. Disclosure No.

Effect of SARS-CoV-2 viral infection on male sexual hormones levels post COVID-19 exposure: A systematic review and meta-analysis.

The COVID-19 can affect human testicles, thus will interfere the production of important male sexual hormone such as testosterone. Our study provides scientific evidence through systematic reviews and meta-analyses that focus on the effects of SARS-CoV-2 virus infection on male sexual hormonal disorders in patients post-exposure to COVID-19. This meta-analysis was made in accordance with the PRISMA guidelines. The outcomes of this study were the level of total testosterone, free testosterone, LH and FSH. Chi-square and I2 tests were used to evaluate heterogeneity between studies. The standardized mean deviation (SMD) with 95% CI were used and analysis was performed using the Review Manager 5.4 software. The four included studies reported a total of 256 patients with COVID-19 with time of follow-up time post COVID-19 varying from one month to 7 months. The mean age distribution in the study was 34-57 years old. Total testosterone level (SMD = -158.71; 95% CI= -205.30 - -112.12; p<0.00001) was significantly higher at follow-up post COVID-19, while LH (SMD = 0.40; 95% CI = 0.15-0.65; p=0.002) was lower. The free testosterone level and FSH level showed no significant difference between baseline and after following up post COVID-19. At follow up, the total testosterone level in patients with SARS-CoV-2 infection appeared to be elevated while LH was lower compared to the baseline.

The Correlation Study Between Testosterone Levels and Hba1c In Type 2 Diabetic Patients Compare with Healthy Persons

The purpose of this study was to evaluate the the connection between hemoglobin glycated (Hba1c) and testosterone levels in the patients of type 2 diabetes mellitus compare with healthy person, also determine the significant differences between this parameter among healthy and diabetic patients, after assumed whole blood and serum specimens from laboratory of Diabetes and Endocrinology Center in Marjan hospital and privately owned in Babylon City starting in October 2022 to February 2023. The outcomes showed non-significant (P&gt;0.05) variations between those with diabetes and control groups in age , which refer to all persons in the same age, also it revealed significant increase (P ˂ 0.05) in Hba1c level in diabetic group compare with healthy men, which may refer to disease effect on these patients and lead to elevation in Hba1c in diabetic group, also it was revealed significant decrease (P ˂ 0.05) in diabetic group compare with control in Testosterone level, in addition to significant increase (P˂0.05) in body mass index in diabetic men compare to control group, and The results showed negative correlation between glycated hemoglobin and testosterone levels in both healthy and diabetic men. The research was concluded that HbA1c value is associated with testosterone levels in diabetic patients.

Impact of combined novel hormonal agents on testosterone levels of patients with prostate cancer undergoing treatment with leuprorelin.

95 Background: Novel hormonal agents (NHA) are part of the management of prostate cancer (PCa) since from the high-risk localized disease throughout the disease continuum, while sustained androgen deprivation therapy (ADT), through the utilization of gonadotropin-releasing hormone (GnRH) agonists or antagonists, stands as the cornerstone of this combined treatment regimen. Although deeper and earlier PSA response rates were demonstrated with these combinations, there is a lack of information on the testosterone levels during the treatment with this doublet. In this retrospective real-world study, we meticulously analyzed data on testosterone tests obtained from a prominent Brazilian institution to comprehensively assess the clinical efficacy of leuprorelin either in monotherapy or in combinations on the management of PCa. Methods: We conducted a retrospective analysis by gathering data from the medical records of pts diagnosed with PCa who were undergoing treatment with leuprorelin alone or in combination with a novel hormonal agent (NHA). Descriptive statistics was assessed by medians and comparison between groups was assessed by chi-square test. This data collection spanned a nine-year period from 2014 to 2023. Results: A total of 1,744 tests were collected from 240 individual pts. Median baseline testosterone level was 373.9 ng/mL among those treated with leuprorelin monotherapy and 368 ng/mL for those receiving leuprorelin + NHA. Testosterone levels &lt; 50 ng/mL were achieved in 776/786 tests (98.7%) of pts receiving leuprorelin and 945/958 tests (98.6%) in pts receiving leuprorelin + NHA (p=0.9). Testosterone levels &lt; 20 ng/mL were found in 633/786 tests (80.5%) of pts receiving leuprorelin and 842/958 tests (87.9%) in pts receiving leuprorelin + NHA (p &lt; 0.0001). Conclusions: In this robust institutional database analysis, we demonstrated that leuprorelin demonstrated similar levels of testosterone suppression (&lt; 50 ng/mL) both in monotherapy or combined with NHA. However, when analyzing deeper testosterone suppression levels, the addition of NHA was associated with statistically significant difference in the rate of patients with testosterone &lt; 20 ng/mL. These results reinforce the importance of intense hormonal treatment in pts with PCa receiving leuprorelin.

ARAMON: A phase 2, randomized, open-label study comparing darolutamide (DARO) vs enzalutamide (ENZA) monotherapy on serum testosterone levels in patients (pts) with castration-sensitive prostate cancer (CSPC) after biochemical recurrence (BCR).

TPS243 Background: DARO, a structurally distinct and highly potent androgen receptor inhibitor, has low blood–brain barrier (BBB) penetration and limited potential for drug–drug interactions. In phase 3 trials, DARO showed significant efficacy and a favorable safety profile. In ARAMIS (NCT02200614), DARO and androgen-deprivation therapy (ADT) significantly improved metastasis-free survival and overall survival (OS) vs placebo + ADT in pts with nonmetastatic castration-resistant prostate cancer. In ARASENS (NCT02799602), DARO + ADT + docetaxel significantly improved OS in pts with metastatic hormone-sensitive prostate cancer vs placebo + ADT + docetaxel. In both studies, the incidence of adverse events (AEs) was similar between treatment groups. Currently, the ARASTEP study (NCT05794906) is evaluating DARO and ADT in pts with high-risk BCR following primary therapy who have prostate-specific membrane antigen PET/CT-positive lesions. Based on a neuroimaging study of healthy volunteers, cerebral blood flow was not altered with DARO but was significantly reduced in brain areas related to cognition with ENZA. It is postulated that the low BBB penetration of DARO may result in lower serum testosterone elevations than those seen with ENZA, which may reduce the frequency of AEs. The ARAMON study (NCT05526248) will compare the effect of DARO and ENZA monotherapy on post-treatment testosterone levels in pts with CSPC who developed a BCR after definitive treatment for localized disease. Methods: ARAMON is a two-stage, open-label, phase 2 study of pts with histologically or cytologically confirmed adenocarcinoma of the prostate who experienced BCR after radical primary prostatectomy (RP) or radiation therapy (RT), with &lt;5 asymptomatic oligometastatic disease sites. Key inclusion criteria are prostate-specific antigen (PSA) ≥2 ng/mL, PSA doubling time of ≤20 months, serum testosterone &gt;150 ng/dL, and Eastern Cooperative Oncology Group performance status 0/1. During the lead-in phase, 25 pts will receive DARO 600 mg twice daily for 52 weeks. If serum testosterone criteria are met at 12 weeks, the study will proceed to the randomized phase where approximately 40 pts will be randomized 1:1 to DARO (600 mg twice daily) or ENZA (160 mg once daily) for 52 weeks. The primary endpoint is the change in serum testosterone level from baseline to Week 12. Secondary endpoints include the change in serum testosterone levels from baseline to Weeks 24 and 52; PSA at Weeks 4, 12, 24, 36, and 52; changes in blood levels of endocrine, glycemic, and lipid metabolism markers; incidence of AEs; and quality of life. As of September 2023, 23 of 25 planned pts in the lead-in phase have been enrolled. Clinical trial information: NCT05526248 .

Is There Any Relation Between High-Grade Prostate Cancer and Central Obesity, Hyperinsulinemia and Dyslipidemia?

Background: Prostate Cancer (PCa) is the sixth leading cause of cancer death in men, worldwide. Incidence of prostate cancer in India is on the rise. Most studies suggest that obesity has a positive correlation with a higher risk of developing high-grade PCa and dying of PCa. Central obesity and related biochemical alterations in terms of hyperinsulinemia and dyslipidemia are associated with severity of prostate cancer in terms of high Gleason score. Materials &amp; Methods: Central obesity was assessed using anthropometric measurements including waist hip ratio (WHR) and body mass index (BMI). Serum PSA, testosterone, and insulin levels were estimated. Serum levels of triglycerides (TG), cholesterol, low-density lipoprotein (LDL), and very low-density lipoprotein (VLDL), high-density lipoprotein (HDL) were also measured. Standard staging procedures were followed and for histopathological evaluation of PCa, Gleason grading was done on core biopsy tissue. Results: In the present population-based study, persons with high Gleason score had significantly higher WHR supporting that central obesity may predispose to high-grade prostate cancer. Study has shown a significant relationship between high Gleason score and cholesterol, TG, VLDL, and low HDL levels; however no significant relation was found with LDL levels. Testosterone is a key prostate growth factor although PCa presents at an age when testosterone levels are declining. Conclusion: In this study, there was no significant difference in testosterone levels in patients with high and low Gleason scores. Keywords: Prostate, Cancer, High grade, Low grade

Preoperative and postoperative blood testosterone levels in patients with acromegaly: a prospective study.

To investigate the prevalence of low blood testosterone level (LTL) and its determinant factors among active male acromegaly patients, as well as the effect of surgery on LTL in male acromegaly patients. A retrospective, single-center study focused on 252 male acromegaly patients aged 18 years-60 years diagnosed in the Peking Union Medical College Hospital from January 2015 to December 2018 was carried out. The measurements of preoperative and postoperative testosterone levels, serum growth hormone (GH), insulin-like growth factor 1 (IGF-1), and other clinical data were analyzed. Forty per cent of subjects included were diagnosed with LTL pre surgery. Patients were divided into normal testosterone level (NTL) and LTL groups based on their testosterone level. There were significant differences (p < 0.01) between groups in the presence of macroadenomas, invasion of the cavernous sinus, compression of the optic chiasm, and serum GH and prolactin levels pre surgery. Invasion of the cavernous sinus [odds ratio (OR) = 4.299; p = 0.000] and serum prolactin level (OR = 1.023, p = 0.001) were independent predictors of LTLs in male patients before surgical intervention. A total of 67.9% of LTL patients recovered during the follow-up, with a new-onset rate of 3.4%. Body mass index, invasion of the cavernous sinus, GH, IGF-1, and prolactin levels, the presence of a prolactin-secreting tumor, and recovery from acromegaly were significantly different (p < 0.05) in the NTL group and in the LTL group during the follow-up. The presence of a prolactin-secreting tumor (OR = 0.224; p = 0.001) and recovery from acromegaly (OR = 0.168; p = 0.006) were independent predictors of LTLs in male acromegaly patients during the follow-up. The invasiveness of tumor and levels of blood prolactin are independent factors for LTLs before surgery, whereas GH and IGF-1 levels are not. Most male patients can recover from LTL after tumor restriction surgery: those who recover from acromegaly have a better chance of recovering from LTL.

Prognostic impact of serum testosterone in metastatic hormone-naive prostate cancer: a systematic review and meta-analysis.

In daily practice, there is an unmet medical need for biomarkers that facilitate therapeutic decision-making in the metastatic hormone sensitive prostate cancer (mHSPC) scenario. Although recent studies have highlighted the potential of testosterone as a prognostic and predictive marker in prostate cancer, the evidence is controversial. The objective of this review was to summarize and analyze the scientific evidence regarding the prognostic role of basal testosterone levels in patients with mHSPC. A systematic review was performed. Three authors selected the articles from Web of Science, PubMed, Scopus, and Cochrane Library electronic databases. Risk of bias was assessed by the Newcastle Ottawa Scale. Most of the selected articles suggest that low testosterone levels before starting hormonal blockade imply a worse prognosis for patients with mHSPC. However, the quality of the evidence is poor, the studies are heterogeneous, and it is not possible to meta-analyze most of the published results. Testosterone is an accessible and affordable biomarker. If it were correctly demonstrated that it harbors a prognostic and/or predictive role in the mHSPC setting, it could represent an advance in decision-making in these patients. Well designed prospective studies are needed to correctly answer this question.

Prognostic significance of serum testosterone level in patients with castration-resistant prostate cancer treated with cabazitaxel.

Serum testosterone level is a potential prognostic marker for castration-resistant prostate cancer. However, its role as a prognostic marker in cabazitaxel chemotherapy remains unclear. This study aimed to elucidate the clinical significance of serum testosterone levels before cabazitaxel chemotherapy. This single-institution, retrospective study included 47 patients with metastatic castration-resistant prostate cancer (mCRPC) who received cabazitaxel therapy. Serum testosterone levels were measured before the initiation of cabazitaxel therapy. Progression-free survival and overall survival (OS) were not significantly different between patients with high and low serum testosterone levels. Analysis of patients aged <70 years revealed that those with high serum testosterone levels (total testosterone level > 0.055 ng/mL) had significantly longer OS than those with low serum testosterone levels (total testosterone level < 0.055 ng/mL, p = 0.012). Multivariate analysis revealed that low serum testosterone levels (hazard ratio [HR] = 11.874, 95% confidence interval [CI] 2.076-67.953, p = 0.005) and high prostate-specific antigen levels (HR = 18.051, 95% CI 2.462-132.347, p = 0.004) in the pretreatment phase were independent prognostic factors for OS in patients receiving cabazitaxel therapy. Serum testosterone level may be a prognostic marker for cabazitaxel therapy in patients with mCRPC who are younger than 70 years, and high serum testosterone levels may lead to longer survival.

A phase 2, randomized, open-label study comparing the effects of darolutamide versus enzalutamide monotherapy on serum testosterone levels in patients with hormone-naive prostate cancer: ARAMON study.

TPS5111 Background: Darolutamide is a structurally distinct and highly potent androgen receptor inhibitor with low blood–brain barrier penetration. In the phase 3 ARAMIS study (NCT02200614) of patients with nonmetastatic castration-resistant prostate cancer, treatment with darolutamide significantly improved metastasis-free survival and overall survival versus placebo, with a favorable safety profile. The incidences of central nervous system adverse events (AEs; e.g. falls, memory impairment, and depression) showed a ≤2% difference between the darolutamide and placebo groups. Fatigue was the only AE with an incidence of &gt; 10% for darolutamide (13.2% vs 8.3% for placebo). In a separate neuroimaging study of healthy volunteers, cerebral blood flow was not altered in patients treated with darolutamide but was significantly reduced in brain areas related to cognition in patients treated with enzalutamide. Furthermore, it is postulated that the low blood–brain barrier penetration of darolutamide may result in lower serum testosterone elevations than those seen with enzalutamide, with the potential of leading to fewer associated feminizing AEs. The objective of ARAMON (NCT05526248) is to compare the effect of darolutamide and enzalutamide monotherapy on post-treatment testosterone levels in patients with hormone-naive prostate cancer experiencing biochemical recurrence after definitive treatment for localized disease. Methods: ARAMON is a two-stage, open-label, phase 2 study of patients with histologically or cytologically confirmed adenocarcinoma of the prostate who have biochemical recurrence after radical primary prostatectomy or radiation therapy, with a prostate-specific antigen (PSA) doubling time of ≤20 months, baseline serum testosterone &gt; 150 ng/dL, and Eastern Cooperative Oncology Group performance status 0/1. During a 52-week lead-in phase, 25 patients will receive darolutamide 600 mg twice daily. If criteria based on serum testosterone increase from baseline to Week 12 are met, the study will proceed to a 52-week randomized phase in which the effects of darolutamide (600 mg twice daily, n = 20) will be compared with the effects of enzalutamide (160 mg once daily, n = 20). The primary endpoint of both phases is the change in serum testosterone level from baseline to Week 12. Secondary endpoints of the randomized phase include the change in serum testosterone levels from baseline to Weeks 24 and 52; PSA at Weeks 4, 12, 24, 36, and 52; changes in blood levels of markers for glucose, lipid metabolism, and endocrine function related to sex hormones; safety; and quality of life. Safety will be assessed through AE monitoring. The first of the 25 planned patients in the lead-in phase was enrolled on January 13, 2023. Clinical trial information: NCT05526248 .

(106) Hormonally-Mediated Vestibulodynia: A Chart Review

Abstract Introduction The borders of the vestibule are Hart’s line laterally, hymen medially, frenulum of the clitoris anteriorly, and fourchette posteriorly. Provoked vestibulodynia (PVD) is characterized by severe burning pain in response to pressure localized to the vestibule. Numerous factors may negatively affect the vestibule causing PVD such as hormonal changes, infections, trauma, exaggerated immunologic or inflammatory responses, dermatologic conditions, high-tone pelvic floor dysfunction, pudendal neuropathy, and sacral radiculopathy. PVD specifically associated with hormonal changes in pre-menopausal women has been termed hormonally mediated vestibulodynia (HMV). Dense labeling of androgen receptors has been noted in the germinal layer of the vestibular epithelium and mucinous minor vestibular glands, implying a critical role of testosterone in vestibular health. Low calculated free testosterone caused by elevated sex hormone binding globulin (SHBG) in pre-menopausal women using combined hormonal contraception may thus be harmful to the vestibular epithelium and minor vestibular glands, resulting in HMV. In HMV, vulvoscopy shows diffuse vestibular tenderness of the entire vestibule, the ostia of the minor vestibular glands are frequently erythematous (Fig 1) and blood testing is consistent with a low calculated free testosterone. Objective We describe the variation in etiologies for HMV and emphasize the importance of measuring total testosterone and SHBG to monitor calculated free testosterone levels in patients with HMV. Methods This is a retrospective chart review of premenopausal patients presenting to a clinic with entrance dyspareunia who were diagnosed with HMV, and whose symptoms were alleviated by treatment. Inclusion criteria were as follows: premenopausal females with initial testosterone and SHBG blood values below the reference range, initial vulvoscopy findings significant for vestibulodynia, follow-up testosterone and SHBG approaching the reference range, and follow-up vulvoscopies demonstrating a relief from symptoms. Results A total of 9 patients met the inclusion criteria. The mean age was 32 years old, with a range of 22 years old to 39 years old. Presenting complaints in addition to dyspareunia (n=9) included recurrent irritative bladder voiding symptoms without positive urine culture (n=3) and pelvic pain (n=4). Vulvoscopic examination including cotton-tipped swab testing of the vestibule revealed signs of vestibular hypersensitivity with pain ranging from 1 to 9 in all 7 regions of the vestibule tested. Patients had histories of having taken combined hormonal contraceptives (n=6), isotretinoin (n=1), spironolactone (n=1) and/or hormonal treatment for breast cancer (n=1), all of which can decrease calculated free testosterone. All patients were treated with systemic testosterone and compounded estradiol/testosterone cream to be applied daily to the vestibule. On follow-up blood testing, all patients had calculated free testosterone values approaching 0.6-0.8 ng/dl, established by Guay et al. as the optimum range. All patients reported significantly decreased dyspareunia and significant relief of other bothersome symptoms, especially bladder symptoms. Conclusions This chart review illustrates a variety of etiologies associated with low calculated free testosterone and the diagnosis of HMV. This data emphasizes the importance of calculating free testosterone and performing vulvoscopy to establish a diagnosis in pre-menopausal patients with entrance dyspareunia. Additionally, this chart review demonstrates the efficacy of systemic testosterone and local vestibular androgen/estradiol therapies in ameliorating vestibular pain and associated symptoms in patients with HMV. Disclosure No

(523) Changes in Testosterone Levels in Patients with Erectile Function

Abstract Introduction Erectile dysfunction (ED) is a disease that affects approximately 20% of adult men. Androgen deficiency is one of the organic etiologies described for this sexual dysfunction. Objective To estimate the frequency of alterations in the sex hormone binding globuline (SHBG), total testosterone (TT), calculated free (FT) and bioavailable testosterone (BT) in Spanish men with a clinical diagnosis of erectile dysfunction in Madrid, Spain. Patients and methods Cross-sectional study. Men over 18 years of age with a clinical diagnosis of erectile dysfunction and a score in the international index of erectile function (IIEF-EF) &amp;lt; 26 were included. Serum levels of SHBG, TT, TL and TB were evaluated and the proportion of men was estimated. with hormonal alterations defined as: a) serum levels &amp;lt;2.49 ng/mL of TT in men under 50 years and &amp;lt;1.93 ng/mL in men of 50 years or older; b) TL for calculated value &amp;lt;2% of total testosterone; c) TB for calculated value &amp;lt;40% of total testosterone; d) serum SHBG levels &amp;gt;54.1 nmol/L in men younger than 50 years and &amp;gt;76.7 nmol/L in men 50 years and older. Results 30 subjects participated in the study. The mean age was 50.6 years (+/− 13.2), the median scores for IIEF-EF, Erection Hardness Score (EHS) and Aging Male Symptoms Score (AMS) were 15 (range 1-24), 2 (range 1-3) and 29.5 (range 11-62) respectively. 6 patients (20%) had severe erectile dysfunction, 13 (43.3%) moderate, 8 (26.7%) mild to moderate, and 3 (10%) mild erectile dysfunction. The mean TT was 4.94 ng/mL (+/− 1.91), FT 1.94% (+/− 0.605), BT 45.6% (+/− 14.2), and SHBG 33.3 nmol/L ( +/− 14.5). Only 6.7% of the patients (n=2) presented alterations of the TT, while in 60% (n=18) an alteration of the FT was found, in 36.7% (n=11) an alteration of the BT and in 3.3% (n=1) SHBG alterations, alterations being more frequent in men with moderate ED. Conclusions Our study found alterations in total testosterone in a small percentage of patients with ED, however the alterations in Free Testosterone calculated turned out to be much higher. This study suggests that future research should be carried out to identify a relationship between changes in calculated free testosterone levels and the presence of erectile dysfunction. Disclosure No

A study of association between serum testosterone levels and clinical aspects of schizophrenia

Background: Sex disparities in schizophrenia especially in negative symptoms may be related to the action of sex steroid hormones. Objective: The purpose of this study was to analyze relationship of serum testosterone levels with respect to clinical psychopathology laying emphasis on negative symptoms in male patients with schizophrenia. Material and Methods: The study population consisted of two hundred male schizophrenia patients and fifty- age matched healthy individuals. Sociodemographic data and history of illness were noted in semi-structured proforma. Clinical psychopathology was assessed by Positive and Negative Syndrome Scale (PANSS). Drug Induced Extrapyramidal Symptoms Scale (DIEPSS) and Calgary Depression Scale for Schizophrenia (CDSS) were also used to exclude the effects of extrapyramidal symptoms and depression. Serum testosterone level was measured by chemiluminescence method. Data were analyzed by chi square test (x2) and z-test. Pearson’s correlation analysis was used for association of testosterone level with PANSS sub-scale scores. Results: Mean testosterone level was significantly lower in schizophrenia patients (381.90±158.29; p ˭ 0.001) as compared to healthy subjects (520.51±145.94). A significant inverse association was detected between PANSS negative sub scale scores and testosterone levels (r ˭ -0.211, p ˭ 0.034). There was no correlation with other PANSS sub scale items (i.e., positive symptoms, general psychopathology and total scores), age of onset and disease duration. Conclusion: The present study indicates that lower level of testosterone may have a role in presentation of negative symptoms in schizophrenia, and the pathophysiological processes of disease affected the testosterone levels. Therefore, clinicians are advised to monitor levels of testosterone in patients with predominant negative symptoms of schizophrenia and enquire about sexual dysfunction and infertility. Lower level of sex steroids is a point of concern as these patients are at high risk of osteoporosis and cardiovascular co-morbidities. In near future therapeutic strategies targeting testosterone could be useful in ameliorating the negative symptoms of disease.

Effect of Varicocelectomy on Serum Follicle-Stimulating Hormone and Testosterone; The Interrelationship Between Hormonal Variables.

The present study was conducted to analyze the effect of varicocelectomy on serum follicle-stimulating hormone (FSH) and testosterone. The interrelationship between seminal and hormonal variables is also investigated. A prospective cohort study was conducted on patients of the urology clinic from 2012 to 2017. The study was conducted in the Security Forces Hospital, in Riyadh, Saudi Arabia. Infertile patients who had already undergone the FSH examination and testosterone twice were included in the study. Statistical Package for Social Sciences (SPSS) version 21.0 was used to analyze the data. A total of 186 patients were studied which reveals that the age group of 21-30 years was higher than other age groups 80 (43%), micro varicocelectomy was performed in 138 (74%) of patients and 79 (47%) patients had one-year infertility. The study assessed the effect of varicocelectomy on sperm count and motility serum FSH, testosterone, luteinizing hormone (LH), and prolactin, and it was found that none of the variables showed significant association after varicocelectomy, except for luteinizing hormone (P-value = 0.014). Testosterone levels in patients who had FSH ≤10 were also evaluated and it was found that the level of testosterone was increased with a decreased level of FSH (P-value = 0.005). It was concluded from our results that after varicocelectomy, those patients who had FSH levels ≤10 were found to have increased testosterone levels. LH was also found to be significant; however, other hormones were not found to be significant. This may occur due to the reason that we have the majority of the participants in the age group 21-30. Further prospective studies are needed to evaluate the association with ample sample size.

The Fatty Liver Index, the Strongest Risk Factor for Low Testosterone Level

Introduction: The study aimed to determine if hepatic steatosis assessed by fatty liver index (FLI) was an independent risk factor for male low testosterone level and whether the FLI was the strongest risk factor for low testosterone level in two different age groups. Methods: Two cross-sectional studies were performed. A total of 3,443 male participants (aged 46–75) were recruited into study A (part of lONgitudinal study (REACTION)). Then a total of 267 male participants (aged 25–45) were recruited into study B. Serum total testosterone (TT) and sex hormone-binding globulin (SHBG) levels, indicators for assessing hepatic steatosis were measured. The Pearson correlation and regression analysis were performed to investigate the risk factors for low testosterone level. Results: The FLI had the strongest negative correlation with serum testosterone in the study A (r = −0.436) and B (r = −0.542). Compared with patients with a FLI lower than 30, the risk for low testosterone level increased by 3.48-fold in subjects with a FLI higher than 60 adjusted for potential risk factors in study A. In study B, the odds ratio of low testosterone level in patients with potential hepatic steatosis was 4.26 (1.57–11.60) after adjusted for age and homeostasis model assessment of insulin resistance (HOMA-IR) and 0.59 (0.14–2.60) after adjusted for age, HOMA-IR, waist circumference, body mass index, and SHBG. Conclusions: FLI was the strongest risk factor for male low testosterone level independent of insulin resistance in male populations of different ages; however, the association can be modulated by SHBG levels in the young. Significance Statement: In the study, FLI was the strongest negative risk factor for low testosterone level in the Chinese adult male population. The results suggested that hepatic steatosis assessed by the FLI was the main risk factor for male low testosterone level, independent of age, insulin resistance, smoking, and drinking status; however, the association of FLI and TT levels can be modulated by SHBG levels. Taken together these findings indicate that clinical physicians should pay more attention to the FLI index and hepatic steatosis, so that they can take advantage of them for assessing the risk of developing of low testosterone level in the male population.

Is There a Two-Way Risk between Decreased Testosterone Levels and the Progression and Prognosis of Chronic Kidney Disease? A Cohort Study Based on the National Health and Nutrition Examination Survey Database.

The causal relationship between the incidence and prognosis of chronic kidney disease (CKD) and serum testosterone levels in patients is not yet fully understood. This study aims to use the National Health and Nutrition Examination Survey (NHANES), a large-scale nationally representative sample, to investigate the relationship between CKD and testosterone. This study included six NHANES cycles for linear regression analysis, verified by multiple imputation methods. Stratified analysis and subgroup analysis were used to demonstrate the stability of CKD's effect on testosterone. Furthermore, we used Kaplan-Meier plots and log-rank tests to evaluate differences in survival rates between CKD male patients with low and normal levels of testosterone. From a total of 71,163 subjects, the cohort selected 28,663 eligible participants. Results showed that CKD patients had testosterone levels 28.423 ng/mL (24.762, 32.083) lower than non-CKD patients. The results of multiple imputations (β=27.700, 95% confidence interval: 23.427, 31.974) were consistent with those of linear regression analysis, and the numerical match was good. Stratified regression analysis, and subgroup analysis results showed that CKD had a significant impact on testosterone at different dimensions. Kaplan-Meier plots showed significantly reduced survival rates in low testosterone CKD male patients (p<0.0001). The results of this big data analysis suggest that there may be a two-way risk between low levels of testosterone and CKD. The testosterone levels of CKD patients were significantly lower than those of the non-CKD population, and CKD patients with low testosterone levels had poorer prognoses. These results suggest that correcting testosterone levels in a timely manner can have preventive and therapeutic effects on the progression of CKD.

Examining the Effect of Chamomile on Clinical Symptoms and Hormonal Parameters Among Patients With Polycystic Ovarian Syndrome.

Polycystic ovarian syndrome is the most common cause of infertility and endocrine disorder among women due to anovulation. The aim of the present study is to investigate the effect of chamomile on oligomenorrhea and hirsutism symptoms as well as hormonal parameters among patients suffering from polycystic ovarian syndrome. The present study is a randomized clinical trial performed on 70 patients with diagnosis of polycystic ovarian syndrome according to Rotterdam criteria referring to the infertility clinic of a university hospital. The patients were randomly assigned into intervention and control groups, with the former receiving two chamomile capsules 500 mg for three months, and the latter receiving two placebo capsules for 3 months. Both groups were evaluated in terms of laboratory parameters (FBS, LDL, and testosterone) on the third day of first and third cycles. The collected data were analyzed by SPSS 20. The mean age, body mass index, marital status, history of infertility, and pregnancy rate showed no significant difference between the two groups. In the chamomile group, clinical symptoms of hirsutism (p<0.001) and oligomenorrhea (p=0.048) decreased following the treatment, but significant difference was found between the two groups only in hirsutism symptoms (p=0.028). Regarding the parameters of FBS (p=0.06), HDL (p=0.224), cholesterol (p=0.99), triglyceride (p=0.106), testosterone (p=0.894), and LDL (p=0.61), no significant difference was observed between the two groups. Nevertheless, following the treatment, testosterone decreased in both placebo (p=0.005) and chamomile (p=0.001) groups. overall, the chamomile therapeutic regimen has relatively been able to mitigate the clinical symptoms and testosterone levels in patients suffering from polycystic ovarian syndrome. Use of chamomile plant as a simple, inexpensive, and effective measure can be suggested for improving and treating patients with PCOS after confirmation by further studies.

Is it necessary to check the level of total testosterone in patients referred for intracavernosal injection?

It is recommended to test total testosterone in the blood (BT) in patients who are evaluated for erectile dysfunction Our aim was to assess the need for a BT test in patients referred for ICI treatment. Medical records of men evaluated at the ED clinic and were referred for ICI training/ treatment were reviewed for BT levels. 55 consecutive medical records of patients planned for injections between 11.2019-05.2020 were examined. In four patients testosterone values ​​were below 0.5 nmol/liter. All 4 were on hormone therapy due to prostate cancer, therefore these patients were excluded from the analysis of the results. Out of the remaining 51 patients, six had BT levels ​​of 1.7-8.1 nmol/liter and were considered hypogonadal, one patient had a borderline BT level of 10.2 nmol/liter. In the other 44 patients, BT levels ​​were >10.3 nmol/liter and were defined as eugonadal. Thus, in 86% of patients, BT levels were within the normal range. In the age of economic medicine today, when cost is a significant component in the set of medical considerations, we believe that there is no need to re-examine testosterone levels in patients referred for ICI training. Apparently patients but have already undergone "screening" of testosterone levels by the attending physician. It is possible that a normal testosterone level in the blood causes a preserved sexual desire and is responsible for the aspiration and desire of the patients to continue invasive treatment of the second line by ICI. No conflict of interest

Clinical outcomes of testosterone replacement therapy in Japanese patients with late onset hypogonadism (LOH) syndrome

ABSTRACT Objectives The Japanese late-onset hypogonadism (LOH) guideline is using serum free testosterone (FT) level for diagnosis of LOH syndrome. On the other hand, the European and American guidelines are using total testosterone level (TT) for diagnosis of LOH syndrome. Serum total testosterone levels below 8 nmol/L (231 ng/dL) require substitution of testosterone in the E.A.U. recommendations. In this study, we compared serum free testosterone level and total testosterone level in patients who visited our LOH syndrome out-patient department. We also investigate clinical outcomes of testosterone replacement therapy (TRT) in patients with LOH syndrome. Material and Methods Two hundred thirty male patients who visited our LOH syndrome out-patient department from January, 2008 to September, 2017 were targeted at this study. The patient's average age was 55.1 years old. Average of AMS score in patients was 51.7 points. Results Only 20 patients (8.7%) were low value (less than 2.31ng/ml) and 86 (37.4%) patients were low and borderline value (less than 3.46ng/ml) in serum total testosterone (TT) level. On the other hand, 99 patients (43.1%) were low values (less than 8.5pg/ml), and also 175 examples (76.1%) were low and borderline value (less than 11.8pg/ml) in serum free testosterone (FT) level. Testosterone replacement therapy (TRT) was carried out for 3 months in 84 patients with patient with LOH syndrome. Sixty nine patients (82.1%) were effective for ART. Only four patients dropped out TRT because of dysuria and plethora. Fifty four patients (83%) with patients who were low value (l less than 8.5pg/ml) in serum free testosterone (FT) were effective for ART in 53 patients. Also 25 patients (80.6༅) who was borderline value (less than 11.8pg/ml) in serum free testosterone (FT) level were effective for TRT in 31 patients. Conclusions Including borderline case, high frequency patient is suited at the diagnostic criteria of LOH syndrome using serum FT value compared to TT value. It might be necessary to also consider measurement of the auxiliary total testosterone, and compensation of the isolation testosterone by age. Testosterone replacement therapy (TRT) was also effective in patients with LOH syndrome not only low value but also borderline value in serum free testosterone (FT). Disclosure Work supported by industry: no.