Symptoms Of Testosterone Deficiency Research Articles

MP35-14 PATIENT SATISFACTION AFTER SWITCHING TO ORAL TESTOSTERONE UNDECANOATE IN MEN CURRENTLY RECEIVING TESTOSTERONE THERAPY: AN OPEN-LABEL SINGLE-CENTER PHASE IV CLINICAL TRIAL

You have accessJournal of UrologyCME1 May 2022MP35-14 PATIENT SATISFACTION AFTER SWITCHING TO ORAL TESTOSTERONE UNDECANOATE IN MEN CURRENTLY RECEIVING TESTOSTERONE THERAPY: AN OPEN-LABEL SINGLE-CENTER PHASE IV CLINICAL TRIAL Rohit Reddy, Mehul Patel, and Ranjith Ramasamy Rohit ReddyRohit Reddy More articles by this author , Mehul PatelMehul Patel More articles by this author , and Ranjith RamasamyRanjith Ramasamy More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002589.14AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Testosterone deficiency (TD) is defined by an insufficient production of testosterone (T) combined with symptoms such as decreased libido. Multiple delivery systems such as gels and injections are currently available; however, oral formulations have been unavailable in the United States due to hepatoxicity and variable bioavailability. Oral formulations of T are convenient, easy to use, and avoid the problems of other forms of testosterone therapy (TT) such as painful injections and transference. Jatenzo® is a novel US FDA approved formulation of oral T undecanoate that provides a uniform response. In this study, we evaluated patient satisfaction of Jatenzo® as compared to other forms of T. We hypothesize Jatenzo® will have similar patient satisfaction compared to other forms. METHODS: Qualifying patients between ages 18 and 65 with TD symptoms and two T levels <300 ng/dL were recruited into this 26-week single-center open-label non-randomized phase IV clinical trial. Patients were required to previously have received TT, completed an adequate washout period, and then were started on Jatenzo®. The primary outcome was Treatment Satisfaction Questionnaire for Medication (TSQM-9), a validated questionnaire for medication satisfaction, as well as changes in TD symptoms as measured by the quantitative Androgen Deficiency in the Aging Male (qADAM) questionnaire at the 3 and 6 month intervals compared to baseline. Serum T, PSA, hematocrit, and estradiol were also evaluated at each time point. RESULTS: Of the patients recruited, 53% were previously on subdermal pellets, 27% on intramuscular injections, 13% on dermal gels, and 7% on nasal gels. T levels increased from a baseline mean of 201 ng/dL to 686 ng/dL at 1 month and 527 ng/dL at 3 months. Patient satisfaction as measured by TSQM-9 remained similar on oral T undecanoate at 38.3 compared to 39.3 on the prior TT. TD symptoms as measured by qADAM were also similar at 34 compared to 33.5 on prior TT. No significant difference was noted in side effects such as polycythemia or changes in estradiol and PSA. CONCLUSIONS: Oral T undecanoate appears to provide similar patient satisfaction and similar improvement in TD symptoms as other forms of TT. In addition, it increases serum total T to the normal range (300–1000 ng/dL) in >90% of men without a difference in side effect profile. Source of Funding: Investigator-initiated grant provided by Clarus Therapeutics to RR. Trial registration: NCT04983940. Registered 30 July 2021. https://clinicaltrials.gov/ct2/show/NCT04983940 © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e592 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Rohit Reddy More articles by this author Mehul Patel More articles by this author Ranjith Ramasamy More articles by this author Expand All Advertisement PDF DownloadLoading ...

Management of Acromegaly associated Late-onset hypogonadism by Siddha medicine: A case report

Male Hypogonadism is the condition diagnosed in men with signs and symptoms of testosterone deficiency. Hypogonadism may be further classified as primary or secondary caused due to organic or functional pathology. This classification has significant therapeutic implications for instituting gonadotropin therapy to restore testosterone levels, spermatogenesis and so fertility is possible in secondary hypogonadism but not in primary hypogonadism. Testosterone replacement therapy (TRT) remains the mainstay and primary therapeutic option in the treatment of hypogonadism. In this case report, we discuss acromegaly associated Late-onset hypogonadism (LOH) treated successfully with Siddha medicine regimen on screening with Androgen deficiency in aging male (ADAM’s) Questionnaire, laboratory investigation of total testosterone level and evaluated the patient’s quality of life using the Aging Male’s symptoms scale (AMS) for prognosis. Siddha treatment regimen such as Poonaikali vidhai chooranam with Amukkra chooranam was administered for one year. Total testosterone level improved from 70 ng/dl to 172 ng/dl and ADAM’s score reduced from 49 to 27, while AMS score reduced from 5 to 1 indicating an alternative ray of hope to TRT.

History of testosterone therapy through the ages.

The symptoms of testosterone deficiency have been known throughout history with evidence dating back to the twenty-first century BCE when men were castrated to be docile and obedient servants. Experimentation ingesting mammalian testicles began during the reign of the Roman empire and continued through the nineteenth century with claims that the substance found within these testicles could improve energy, erectile function, and urination. In the twentieth century, studies transplanting animal testes onto other castrated animals suggested that a substance produced in the testicle was responsible for systemic effects. Then in 1929, Adolf Butendant was the first to isolate testosterone and shortly after synthetic formulations of testosterone were created. While testosterone therapy is an important treatment for testosterone deficiency, the history of testosterone therapy has not been without abuse from doping scandals in the twentieth century and the use of testosterone therapy for conversion therapy and treatment of psychiatric disease. Today, there are clear and appropriate clinical uses of testosterone set by the American Urological Association to treat clinically significant testosterone deficiency. Still, even with such guidelines, the potential for misuse and abuse remains high in physicians and athletes. There is a long history that has led to the development of testosterone therapy and when used appropriately can significantly improve the quality of life for men with testosterone deficiency.

How the rise of testosterone therapy in men was inspired by lizard research with David Crews.

A chance encounter in 1975 with David Crews in Harvard Square led to 3 years of research in his lab, investigating the role of testosterone (T) in male sexual behavior of the lizard, Anolis carolinensis. In 1988 when I began my practice as a urologist and specialist in men's health, my research experience with lizards led me to offer testosterone therapy (TTh) to men suffering with symptoms of testosterone deficiency, despite the universal belief that TTh caused prostate cancer (PCa). My investigation of this topic over 30+ years has led to revolutionary changes in the diagnosis and treatment of men with testosterone deficiency and our understanding of the biology of testosterone and PCa. Today, it is routine for men successfully treated for PCa to receive TTh, a remarkable fact given that standard treatment for men with advanced PCa has been androgen deprivation for the last 80 years. Our research showed low T was not protective for PCa; TTh did not appear to worsen PCa for various cancer stages; and provided the theoretical framework for understanding why androgen deprivation shrinks PCa tumors, yet TTh appears to not cause PCa growth under most conditions. This is based on the Saturation Model, which recognizes there is a finite ability of androgens to stimulate PCa growth, which becomes maximal at low T concentrations. David Crews was an outstanding mentor-the lessons I learned from him inspired a lifetime of work, which in turn led to improved quality of life for millions of men.

Long-term testosterone undecanoate treatment in the elderly testosterone deficient male: An observational cohort study.

Quarterly intramuscular injections with long-acting testosterone undecanoate (TU) provide stable serum testosterone concentrations over time and are therefore preferred by many testosterone-deficient patients. However, the use of long-acting TU in elderly patients is limited due to lack of safety and feasibility studies. To investigate long-acting TU pharmacokinetics and assess differences in treatment regimens and risk of adverse outcomes in younger versus elderly testosterone-deficient patients. Single-center longitudinal observational study. Patients who initiated long-acting TU treatment between 2005 and 2010 were included. Elderly patients were born before 1956 and younger patients between 1965 and 1985. TU dose was adjusted yearly through shortening or prolongation of time between injections. Treatment targets were as follows: (1) free testosterone between 0 and -1 SD from the age-adjusted mean, (2) no symptoms of testosterone deficiency, and (3) hematocrit within the normal range. The study population consisted of 63 elderly and 63 younger patients. Median follow-up time during testosterone replacement was 12.1 years. Increasing intervals between TU injections were performed 44% more often in the elderly compared to younger patients and time between TU injections were prolonged 4% more in the elderly patients. The hematocrit, as well as the hematocrit for a given serum testosterone (hematocrit: testosterone ratio), increased with treatment time but did not differ between age groups. During follow-up, 40% of patients-both elderly and younger-experienced polycythemia. Risk of polycythemia did not differ with age. An increased number of adjustments of TU dose are necessary in elderly patients in order to reach treatment targets. TU treatment in elderly testosterone-deficient patients is not associated with an increased risk of polycythemia compared to younger patients if age-adjusted treatment targets are reached.

EQUINOXE study: Impact of relational cohesion and sexuality on the quality of life of patients treated with gonadotropin-releasing hormone agonist for prostate cancer.

ObjectivesTo measure the effect of dyadic adjustment on changes in patients’ quality of life when initiating treatment with gonadotropin‐releasing hormone (GnRH) agonist.Patients and methodsA prospective, multicenter, longitudinal, and non‐interventional study (NCT02630641) that included patients with prostate cancer starting GnRH agonist therapy, and their partners, in 157 centers in France. Data were collected at inclusion and after 6 months of treatment on quality of life (WHOQOL‐BREF), disease perception (B‐IPQ), disease symptoms (QLQ‐PR25), and perception of cohesion within the couple (dyadic adjustment, DAS‐16).ResultsThe Full Analysis Set included 492 patients (median age [Q1;Q3]: 74 [68;80] years). An improvement of the quality of life (defined as the improvement of at least one of the four dimensions of WHOQOL‐BREF) was reported in 290/434 (67%) patients between baseline and follow‐up. Quality of life was better at baseline and follow‐up in patients with good cohesion within the couple than in those with medium or poor cohesion. Factors associated with improvement in quality of life of patients were the following: initial presence of QLQ‐PR25 hormonal treatment‐related symptoms (OR [95% CI]: 3.00 [1.46, 6.17]) suggesting testosterone deficiency symptoms at baseline and initial low level (2.04 [1.12, 3.72]) or absence of sexual activity (2.23 [1.11, 4.50]) before GnRH agonist initiation.ConclusionMen with the greatest improvement in quality of life after initiating hormone therapy were those with, at baseline, testosterone deficiency symptoms (identified by QLQ‐PR25 treatment‐related symptoms score) or no/low sexual activity. Cohesion within the couple was not confirmed as an influence on the evolution of quality of life.

Weight Loss Through Bariatric Surgery in Men Presents Beneficial Effects on Sexual Function, Symptoms of Testosterone Deficiency, and Hormonal Profile

IntroductionMale obesity has a negative correlation with plasma testosterone (T) levels and sexual function (SF).AimTo evaluate the effect of weight loss through bariatric surgery (BS) on SF, low T symptoms, and hormonal profiles in obese men.MethodsThirty-three men who underwent BS participated in this cohort study. Before surgery, all participants underwent clinical examinations, including anthropometric, lipid, glycemic, and hormonal evaluations. SF was evaluated using the International Index of Erectile Function (IIEF) questionnaire; low T symptoms were evaluated using the Aging Males’ Symptoms (AMS) and Androgen Deficiency in the Aging Male (ADAM) questionnaires. The participants were reevaluated 6 months post-surgery.Main outcome measuresSex hormone profile, SF, and low T symptomsResultsAfter BS, a significant increase in mean total T (201 ± 111–548 ± 190 ng/dL, P < .001), free T (5.8 ± 2.8–9.3 ± 3.4 ng/dL, P < .001), bioavailable T (110.3 ± 57.8–198.6 ± 74.3 ng/dL, P < .001), and sexual hormone-binding globulin (19.8 ± 13.7–54.6 ± 23.2 nmol/L, P < .001) levels. There was a significant decrease in estradiol (64.6 ± 27.4–29.2 ± 20.0 [pg/mL], P < .001). SF significantly improved. The total IIEF score increased 5.2 points (62.3 ± 7.4–67.5 ± 7.4, P = .004), erectile function subdomain increased 2.4 points (25.7 ± 4.1–28.1 ± 3.9, P = .011), desire subdomain increased 1.0 points (8.3 ± 1.5–9.3 ± 1.6, P = .006), and intercourse satisfaction subdomain increased 1.2 points (11.4 ± 1.9–12.6 ± 1.8, P = .012). Post-surgery, a 44% reduction (P = .001) was observed in the positive ADAM questionnaire, and improvements in all domains of the AMS questionnaire were found (P < .001).ConclusionSignificant weight loss through BS improves erectile function, hormonal profile, and symptoms of T deficiency.Machado FP, Rhoden EL, Pioner SR, et al. Weight Loss Through Bariatric Surgery in Men Presents Beneficial Effects on Sexual Function, Symptoms of Testosterone Deficiency, and Hormonal Profile. Sex Med 2021;9:100400.

An autofluorescence-based isolation of Leydig cells for testosterone deficiency treatment

Effective procedures for the purification of Leydig cells (LCs) can facilitate functional studies and transplantation therapies. However, current methods to purify LCs from testes are still far from satisfactory. Here, we found that testicular autofluorescence existed in the interstitium along with the gradual maturation of LCs from birth to adulthood. These autofluorescent cells were further isolated by fluorescence-activated cell sorting (FACS) and determined to be composed of LCs and macrophages. To further purify LCs, we combined two fluorescence channels of FACS and successfully separated LCs and macrophages. Of note, we confirmed that the obtained LCs not only possessed high purity, viability and quantity but also had intact steroidogenic activity and excellent responsiveness to luteinizing hormone. Moreover, subcutaneous transplantation of isolated LCs could alleviate the symptoms of testosterone deficiency in castrated mice. In summary, we established an effective autofluorescence-based method for isolating LCs. This method will aid in the future success of using LCs for basic and translational applications.

Gender Bias in Medicine: “How Women Continue to Get the Shaft When It Comes to Testosterone Therapies”

Gender Bias in Medicine: “How Women Continue to Get the Shaft When It Comes to Testosterone Therapies”

Prevalence and Risk Factors of Testosterone Deficiency in Aging Thai Male Outpatients

Background: Testosterone deficiency in men, characterized by a reduced concentration of serum testosterone, causes a constellation of signs and symptoms that may include decreased libido, erectile dysfunction, increased body fat, fatigue, and psychological problem. Testosterone deficiency in adult men is often overlooked, because they ignore their symptoms or attribute them to alternate causes, including aging and underlying diseases that made them lose the opportunity for treatment. The present study aimed to describe the prevalence of testosterone deficiency and to study potential risk factors associated with testosterone deficiency among Thai men in Phramongutklao Hospital. Objective: To determine the prevalence of testosterone deficiency and potential risk factors associated with testosterone deficiency in Thai men. Materials and Methods: Thai male older than 40 years old who visited in urological outpatient unit at Phramongkutklao Hospital between July and October 2018 were included. Demographic data, medical information, and the androgen deficiency in the aging male (ADAM) questionnaires were collected. The participants having symptoms of testosterone deficiency from ADAM questionnaires were requested to measure serum total testosterone levels and were repeated if serum testosterone level was less than 300 ng/dL. Results: Data from 156 men were collected. The mean age of the participants was 67±8.73 years. Prevalence of testosterone deficiency was 5.8%. Obesity, waist circumference at or greater than 90 cm, diabetes mellitus, and dyslipidemia were identified as risk factors of testosterone deficiency. There was an association between three symptoms of ADAM questionnaires, which were decreased libido, erectile dysfunction, and decreased enjoyment of life, with testosterone deficiency. Conclusion: Prevalence of testosterone deficiency among Thai men at Phramongkutklao Hospital is about 5.8%. Clarification of the underlying causes for the changes in testosterone level may provide helpful information so that preventive action can be taken. Low libido, erectile dysfunction, and decreased enjoyment of life may be specific symptoms of testosterone deficiency and should be the questions to ask the suspected patients. Keywords: Testosterone deficiency; Total testosterone; Prevalence; ADAM questionnaires

Preliminary Evaluation of an Order Template to Improve Diagnosis and Testosterone Therapy of Hypogonadism in Veterans.

Testosterone therapy is indicated for the treatment of hypogonadism. Evidence-based guidelines recommend testosterone treatment only for men with symptoms and signs of testosterone deficiency and consistently low serum testosterone concentrations; luteinizing hormone (LH) and follicle-stimulating hormone (FSH) measurements and discussion of risks and benefits of testosterone prior to therapy. However, the US Department of Veterans Affairs (VA) Office of the Inspector General (OIG) report found that health care providers were adhering poorly to guideline recommendations for the diagnosis and treatment of men with hypogonadism. A prior authorization drug request (PADR) testosterone order template was implemented at VA Puget Sound Health Care System. A retrospective chart review was conducted in veterans who were prescribed testosterone and had no previous prescription in the prior year. Eligible veterans were evaluated 6 months before (pretemplate) and after (posttemplate) implementation of the template, and 3 months after removal of alternative testosterone ordering pathways (posttemplate/no alternative ordering pathways) that were discovered after PADR template implementation. We assessed the proportion of eligible veterans with documented symptoms of testosterone deficiency; appropriate diagnosis and evaluation of hypogonadism with ≥ 2 low serum testosterone and LH and FSH levels; and discussion of risks and benefits of testosterone treatment. In the pretemplate period, only 20 of 80 eligible veterans (25%) had a completed PADR for testosterone. In the posttemplate period, 18 of 45 (44%) eligible veterans had a completed PADR but only 7 (17%) had the testosterone order template completed. In the posttemplate/no alternative ordering pathways period, 13 (68%) and 11 (58%) of 19 eligible veterans had a completed PADR and testosterone order template, respectively. In all 3 periods, documentation of clinical symptoms and a discussion of risks and benefits were similar. In contrast, the proportion of veterans who had ≥ 2 low testosterone levels with LH and FSH levels measured in the posttemplate and posttemplate/no alternative ordering pathways periods were higher (41% and 37%, respectively) vs the pretemplate period (23%). Veterans with documented clinical symptoms, discussion of risks and benefits, and ≥ 2 low testosterone with gonadotropin measurements were 100%, 57%, and 71%, respectively, in the posttemplate/no alternative ordering pathways period. Implementation of a PADR order template may be a promising approach to improve the diagnosis of hypogonadism and appropriate testosterone therapy in accordance with established evidence-based clinical practice guidelines, particularly in veterans who are receiving new prescriptions.

Fatty liver index is associated with the risk of testosterone deficiency in aging men without metabolic syndrome.

Non-alcoholic fatty liver disease (NAFLD) is suggested to be a precursor of metabolic syndrome (MetS) and could influence the risk of testosterone deficiency (TD). Fatty liver index (FLI) is a simple and useful screening tool for NAFLD. We determined the association between the risk of NAFLD assessed by FLI and TD in aging Taiwanese men, especially those without MetS. A free health screening program was conducted for men (age: >40years) in a medical center in Kaohsiung, Taiwan. All participants underwent a physical examination; answered a questionnaire assessing demographics, medical history, and clinical symptoms of TD; and provided 20-mL whole blood samples for biochemical, adipocytokine, and hormonal evaluations. The risk of NAFLD was evaluated using FLI. The presence of NAFLD was ruled out if FLI value was <25 and ruled in if FLI value was ≥35. A total of 552 men (mean age: 54.7±7.7years) were enrolled. The prevalence rates of TD and MetS were significantly higher among men with NAFLD than those without NAFLD (both p<0.001). FLI was significantly correlated with total testosterone (TT) and adipocytokines associated with insulin resistance, such as adiponectin, leptin, and retinol-binding protein-4 (RBP-4) levels, respectively (all p<0.001). Among men without MetS, those at risk of and with NAFLD had a 3.82 and 8.50 times higher risk of TD, respectively, than those without NAFLD after adjusting for potential covariates. The FLI is associated with the risk of TD in aging Taiwanese men, especially in those without MetS. Our findings also suggest that insulin resistance may be an important link among the inter-relationships of NAFLD, MetS, and TD. Further population-based studies with larger sample sizes of different ethnicities are warranted to confirm these preliminary results.

Clinical outcomes of 77 TESE treatment cycles in non-mosaic Klinefelter syndrome patients.

ObjectiveThe current study aimed to present the clinical outcomes of 76 azoospermic patients with non-mosaic Klinefelter syndrome (KS), treated with testicular spermatozoa extraction (TESE) followed by intracytoplasmic sperm injection (ICSI) using either fresh or cryopreserved testicular spermatozoa.MethodsWe retrospectively evaluated 76 patients with non-mosaic KS belonging to a special group of cases that besides infertility did not present the classical signs and symptoms of testosterone deficiency. One of the patients repeated the TESE procedure (76 patients, 77 TESE cycles). Sixty of these 76 patients accepted to undergo TESE associated with ovarian stimulation, while 16 patients underwent TESE followed by testicular spermatozoa cryopreservation. Aneuploidy screening of the offspring was performed by Multiplex ligation-dependent probe amplification and by amniotic fluid karyotyping. Statistical analysis used the Chi-Squared Test, Fisher's Exact Test, 2-sided, for rates, and the Independent Samples T-test for equality of means, 2-sided.ResultsTesticular spermatozoa were recovered in 31 (40.3%) of the attempts. The patients underwent 47 ICSI cycles, 25 with fresh testicular spermatozoa and 22 with cryopreserved testicular spermatozoa. Fertilization (63.5% vs. 41.6%, p=0.000), implantation (37% vs. 13.2%, p=0.014), clinical pregnancy (60.9% vs. 19%, p=0.005) and live birth (65.2% vs. 23.8%, p=0.006) rates were higher with fresh testicular spermatozoa. Chromosome analysis of the 21 newborns was normal.ConclusionsThe present data adds further information regarding the recovery rate of spermatozoa after TESE and the embryological and clinical outcomes with fresh and cryopreserved testicular spermatozoa, besides reassuring the safety concerning chromosomal transmission of KS from parents to their offspring.

Association of aging and obesity with decreased 17-hydroxyprogesterone, a serum biomarker of intratesticular testosterone.

Obesity's negative association with serum testosterone can be explained by either decreasing luteinizing hormone (LH) production from the pituitary gland and/or directly impacting intratesticular testosterone production. We hypothesize that obesity will negatively impact intratesticular testosterone levels when compared to those of non-obese men. We performed a cross-sectional analysis of men with symptoms of testosterone deficiency and male infertility between July 2018 and April 2020 to evaluate the association between body mass index (BMI) and age with intratesticular testosterone (using serum 17-hydroxyprogesterone (17-OHP) as a biomarker), and between BMI with LH. Univariable and multiple linear regression analysis were performed using confounding variables to predict 17-OHP and testosterone. A total of 340 men were selected. Median age was 38 [33-44] years, BMI 27.8 [25.4-31.1] kg/m2, serum testosterone 363 [256.3-469.6] ng/dl, 17-OHP 60.5 [39.3-85.8] ng/dl, and LH 4.2 [2.8-5.7] mIU/ml. Older and obese men had lower testosterone compared to younger and non-obese men. Interestingly, increasing age and higher BMI were associated with lower 17-OHP (p < 0.001). Contrarily, age and BMI were not associated with LH levels (p = 0.478). In conclusion, obesity and aging negatively affected 17-OHP independent of LH, suggesting a possible direct effect on testicular function, rather than a secondary effect from a decline in pituitary signaling.

Genetic Variation in the Androgen Receptor Modifies the Association Between Testosterone and Vitality in Middle-Aged Men

BackgroundLow vitality is a common symptom of testosterone deficiency; however, clinical trial results remain inconclusive regarding the responsiveness of this symptom to hormone replacement. AimThe aim of the present study was to determine if the relationship between circulating testosterone levels and vitality would be moderated by the CAG repeat length in the androgen receptor (AR) gene, which influences the receptor’s sensitivity to testosterone. MethodsWe examined 676 men in the Vietnam Era Twin Study of Aging when they were, on average, 55.4 years old (SD = 2.5). Salivary testosterone levels were measured by using 3 samples collected at waking on 3 nonconsecutive days. The average testosterone level was classified as low, normal, or high based on 1-SD cutoffs. Analyses were conducted using multilevel, mixed linear models, which accounted for the nonindependence of the twin data, and adjusted for the effects of age, ethnicity, BMI, chronic health conditions, depressive symptoms, and sleep quality. OutcomesVitality was measured using the 36-item Short Form (SF-36) vitality subscale. ResultsWe observed a significant interaction between salivary testosterone and the AR-CAG repeat length. When the repeat length was short, men with low testosterone had significantly lower vitality. As the AR-CAG repeat length increased, the magnitude of the testosterone effect decreased. Clinical TranslationThe observed interaction between testosterone and variation in the AR gene suggests that men with more sensitive ARs, as indicated by a shorter AR-CAG repeat, are more likely to experience symptoms of age-related testosterone deficiency. Strengths & LimitationsStrengths of the present study include our use of a large community-based sample, the use of multiple testosterone measurements, and the availability of a comprehensive set of covariates that may impact the association of interest. Limitations include the homogeneous nature of the sample with respect to ethnicity, the brevity of the 36-item Short Form vitality subscale, and our inability to establish change in testosterone levels because of the cross-sectional nature of data. ConclusionsThe association between testosterone and vitality appears to be clinically meaningful and is in part dependent on variation in the AR gene.Panizzon MS, Bree K, Hsieh T-C, et al. Genetic Variation in the Androgen Receptor Modifies the Association Between Testosterone and Vitality in Middle-Aged Men. J Sex Med 2020;17:2351–2361.

16 - Quality of life of prostate cancer (PCa) patients with testosterone deficiency symptoms (TDS) before initiation of gonadotropin-releasing hormone (GnRH) agonist therapy, subgroup analysis of EQUINOXE study

16 - Quality of life of prostate cancer (PCa) patients with testosterone deficiency symptoms (TDS) before initiation of gonadotropin-releasing hormone (GnRH) agonist therapy, subgroup analysis of EQUINOXE study

Effects of Testosterone Treatment on Quality of Life in Patients With Chronic Kidney Disease.

Testosterone deficiency (TD) is common and impairs quality of life (QoL) in patients with chronic kidney disease (CKD). However, there are no studies about whether testosterone replacement therapy (TRT) can improve QoL in patients with CKD. Therefore, we investigated the effect of TRT on the QoL of patients with CKD and confirmed the safety of TRT. Twenty-five male patients with stages III–IV CKD whose serum testosterone levels were <350 ng/dl (TD) were enrolled and treated with testosterone gel for 3 months (group II). Age-matched controls with stages III–IV CKD and TD (group I) were recommended to exercise for the same period. Before and after the treatment, the BMI and handgrip strength were checked, serological tests were performed, and questionnaires were administered in both groups. Compared to baseline, there was no significant difference in serum testosterone levels, scores of the 36-Item Short Form Health Survey (SF-36), Aging Males’ Symptoms Scale (AMS), and International Prostate Symptom Score (IPSS), and grip strength in group I after 3 months. In group II, a significant increase in testosterone, hemoglobin (Hb), and hematocrit (Hct) was observed, and grip strength significantly increased after TRT. Significant improvement in scores of SF-36, AMS, and IPSS was also confirmed after TRT in group II. There was a significant difference in testosterone, Hb, Hct, grip strength, and scores of SF-36, AMS, and IPSS between the two groups after 3 months. The patients in group II showed positive results and continued with TRT. Therefore, we conclude that TRT safely improves the QoL and TD symptoms in patients with moderate-to-severe CKD.

Non-testosterone management of male hypogonadism: an examination of the existing literature.

Testosterone deficiency is defined as a total testosterone level <300 ng/dL confirmed on two early morning lab draws. Testosterone therapy has historically been offered to men with symptomatic testosterone deficiency in the form of injections, gels, or pellets. However, these treatments are invasive or have undesirable effects including the risk of drug transference. Additionally, testosterone therapy has been associated with increases in hematocrit and controversy remains regarding the risk of cardiovascular and thromboembolic events while on testosterone therapy. As such, much interest has recently been focused on alternative treatment options for testosterone deficiency in the form of orally-administered medications with more favorable side effect profiles. Lifestyle modifications and varicocelectomy have been shown to raise endogenous testosterone production. Similarly, SERMs and aromatase inhibitors (AIs) have been shown to raise testosterone levels safely and effectively. Human chorionic gonadotropin (hCG) remains the only FDA-approved non-testosterone treatment option for testosterone deficiency in men. However, this medication is expensive and requires patient-administered injections. Over the counter herbal supplements and designer steroids remain available though they are poorly studied and are associated with the potential for abuse as well as increased hepatic and cardiovascular risks. This review aims to discuss the existing treatment alternatives to traditional testosterone therapy, including efficacy, safety, and side effects of these options. The authors suggest that the SERM clomiphene citrate (CC) holds the greatest promise as a non-testosterone treatment option for testosterone deficiency.

Quality of life of prostate cancer (PCa) patients with testosterone deficiency symptoms (TDS) before initiation of gonadotropin-releasing hormone (GnRH) agonist therapy: Subgroup analysis of EQUINOXE study.

232 Background: Both PCa and TDS risk increase with age. Patients may therefore suffer from both conditions, and their quality of life (QoL) be reduced. Unexpectedly, multivariate analysis of the EQUINOXE study (NCT02630641) identified baseline TDS as a significant factor improving QoL after 6 months of GnRH agonist therapy. We therefore aim to analyze baseline parameters of this subgroup. Methods: EQUINOXE was a French prospective, multicenter, non-interventional study. Urologists recruited partner-patient couples with PCa for whom androgen deprivation therapy (ADT) was indicated. Data were collected at inclusion and after 6 months of treatment, on QoL (WHOQOL-BREF), perception of disease (B-IPQ), symptoms of the disease (QLQ-PR25) and perception of cohesion within the patient-partner relationship (dyadic adjustment, DAS-16). TDSat baseline, determined by QLQ-PR25 “treatment related symptoms” score ≥25/100, was the main parameter identified by multivariate analysis in improvement of QoL (OR [95% CI]: 3.0 [1.46, 6.17]. Post hoc subgroup analysis was made to compare baseline parameters of patients with and without TDS. Results: 487 patients were included in this analysis, 26% of whom had TDS at baseline. Symptoms were (quite a bit or very much): feeling of less masculinity (55.2%), hot flushes (41%), weight gain (40.1%) and enlarged nipples (23.1%). Patients with TDS were slightly older than those without TDS (75.3±8.3vs 73.8±8y.o), had significantly worse performance Status (0-1-2+ in 37.0-45.7-17.3% vs 52.8-36.4-10.8%, p=0.0153) and suffered more frequently from recurrent PCa (35.7% vs 24.7%, p=0.0175). Symptoms other than urinary and sexual (but including asthenia) were more frequent (p=0.0126). All dimensions of WHOQOL-BREF were rated significantly worse. Total score of illness (B-IPQ) was worse: 42.2±8.2 vs39.1±9.4, p=0.0040. Cohesion in the couple (DAS score) was worse: 98.6±22.3 vs107.3±20.9, p=0.0006. Conclusions: Patients with TDS experienced at baseline a worse cohesion of the couple and a lower QoL than patients without TDS but benefited relatively more from ADT in term of QoL. Clinical trial information: NCT02630641.

EFFECT OF A COMBINATION OF OMEGA-3 AND ORAL TESTOSTERONE UNDECANOATE ON SERUM TESTOSTERONE LEVELS IN PATIENTS WITH TESTOSTERONE DEFICIENCY

Background and Objective Oral testosterone undecanoate (TU) is taken up by the intestinal lymphatic system. Thus, the dietary lipid content affects TU absorption. This study aimed to investigate the effect of combined omega-3 fatty acids (OMG3) and oral TU on serum testosterone levels in patients with testosterone deficiency (TD). Material and Methods Sixty consecutive patients with symptomatic TD and low serum total testosterone (TT) levels were enrolled and divided randomly into group 1, oral TU 80 mg twice daily for 30 days, and group 2, OMG3 and oral TU 80 mg twice daily for 30 days. Serum TT concentrations and male function scales were evaluated at baseline and 7 days and 1 month post-treatment. Dietary habits were investigated, and caloric and lipid intakes were measured during the treatment periods. Results The groups did not differ in terms of mean age, body mass index, comorbidities, initial serum TT concentrations, and IIEF/AMS scores. After 7 days and 1 month of treatment, serum TT concentrations were only significantly increased in group 2. The degree of increase in TT was higher in group 2 than in group 1 at 7 days and 1 month, although the difference was only significant at 1 month. Both groups exhibited significant improvements in IIEF and AMS scores at 1 month, with no significant inter-group difference. A diet diary study revealed that 23.3% and 20% of both groups did not eat breakfast and both groups consumed <12 g of lipids and <500 Kcals, without significance differences. Conclusion We observed a significant increase in serum TT concentration after 1 month of treatment with the combination of OMG3 and oral TU, compared to with oral TU monotherapy. Therefore, the combination of OMG3 and oral TU can be considered for the treatment of TD in Korean patients with irregular breakfast habits.