Effects of Testosterone Supplementation on Depressive Symptoms and Sexual Dysfunction in Hypogonadal Men with the Metabolic Syndrome |
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| Authors: | Erik J. Giltay Yuliya A. Tishova George J. Mskhalaya Louis J.G. Gooren Farid Saad Svetlana Y. Kalinchenko |
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| Affiliation: | 2. Chair of Endocrinology, The Faculty of Medical Staff Refresher Training, People''s Friendship University of Russia, Russia;3. Department of Endocrinology, VU University Medical Center, Amsterdam, the Netherlands;4. Bayer Schering Pharma, Scientific Affairs Men''s Healthcare, Berlin, Germany;5. Gulf Medical University School of Medicine, Ajman, United Arab Emirates;2. Wilkinson Associates Radnet, Herts, UK;2. ASL Turin, Metabolism and Diabetes Unit, Turin, Italy;3. Department of Medicine3 Policlinico di Messina, Messina, Italy;4. Cardiology Unit, Emergency and Organ Transplantation Department, University of Bari, Bari, Italy;5. Chaira Medical Association, Chieri, Italy;1. Department of UrologyNational Police HospitalSeoulKorea;2. Department of UrologySchool of MedicineKyung Hee UniversitySeoulKorea;1. Center for Genomic and Personalized MedicineGuangxi Medical UniversityNanningGuangxiChina;2. Guangxi Key Laboratory of Genomic and Personalized MedicineNanningGuangxiChina;3. Guangxi Collaborative Innovation Center for Genomic and Personalized MedicineNanningGuangxiChina;4. Department of Occupational Health and Environmental HealthSchool of Public HealthGuangxi Medical UniversityNanningGuangxiChina;5. Institute of Urology and NephrologyFirst Affiliated Hospital of Guangxi Medical UniversityNanningGuangxiChina;6. Department of ChemotherapyThe Affiliated Tumor Hospital of Guangxi Medical UniversityNanningGuangxiChina;7. Department of UrologyFirst Affiliated Hospital of Xinxiang Medical CollegeXinxiangHenan ProvinceChina;1. Sexual Medicine and Andrology Unit, Department of Biomedical, Experimental, and Clinical Sciences, University of Florence, Florence, Italy;2. Endocrinology Unit, Maggiore‐Bellaria Hospital, Bologna, Italy;3. Diabetes Section Geriatric Unit, Department of Critical Care, University of Florence, Florence, Italy |
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| Abstract: | ![]()
IntroductionLow testosterone levels in men are associated with the metabolic syndrome (MetS) as well as with depressive symptoms, low vitality, and sexual dysfunction.AimTo assess the effects of testosterone administration on these subjective symptoms, which have not extensively been studied in hypogonadal men with the MetS.Main Outcome MeasuresThe Beck Depression Inventory (BDI-IA), Aging Males' Symptoms (AMS) scale, and International Index of Erectile Function 5-item (IIEF-5) scale at baseline, 18 and 30 weeks were analysed using multilevel analysis.MethodsIn a randomized, placebo-controlled, double-blind, phase III trial (ClinicalTrials.gov identifier: NCT00696748), 184 men suffering from both the MetS and hypogonadism were included. They were treated for 30 weeks with either parenteral testosterone undecanoate (TU; 1,000 mg IM TU, at baseline, and after 6 and 18 weeks; Nebido®) or placebo injections, 105 (92.9%) men receiving TU and 65 (91.5%) receiving placebo completed the 30-week trial.ResultsThe 184 men were aged mean 52.1 years old (standard deviation [SD] 9.6; range 35–69), with a mean body mass index of 35.5 kg/m2 (SD 6.7; range 25.1–54.8), and a mean total testosterone level of 8.0 nmol/L (SD 4.0). There were significant improvements in BDI-IA (mean difference vs. placebo after 30 weeks: ?2.5 points; 95% confidence interval [CI]: ?0.9; ?4.1; P = 0.003), AMS (?7.4 points; 95% CI: ?4.3; ?10.5; P < 0.001), and IIEF-5 (+3.1 points; 95% CI: +1.8; +4.4; P < 0.001). The effects on the BDI-IA, AMS, and IIEF-5 were strongest in men with baseline total testosterone levels <7.7 mmol/L (i.e., median value).ConclusionsTU administration may improve depressive symptoms, aging male symptoms and sexual dysfunction in hypogonadal men with the MetS. The beneficial effects of testosterone were most evident in men with the lowest baseline total testosterone levels. Giltay EJ, Tishova YA, Mskhalaya GJ, Gooren LJG, Saad F, and Kalinchenko SY. Effects of testosterone supplementation on depressive symptoms and sexual dysfunction in hypogonadal men with the metabolic syndrome. |
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