1236 EFFECTS OF LONG-TERM ANDROGEN REPLACEMENT THERAPY ON PHYSICAL AND MENTAL STATUS IN AGING MALES WITH LATE-ONSET HYPOGONADISM: RESULTS OF A PHASE III, MULTICENTER, RANDOMIZED, CONTROLLED TRIAL

Abstract

You have accessJournal of UrologySexual Function/Dysfunction/Andrology: Evaluation (I)1 Apr 20131236 EFFECTS OF LONG-TERM ANDROGEN REPLACEMENT THERAPY ON PHYSICAL AND MENTAL STATUS IN AGING MALES WITH LATE-ONSET HYPOGONADISM: RESULTS OF A PHASE III, MULTICENTER, RANDOMIZED, CONTROLLED TRIAL Hiroyuki Konaka, Kazuhiro Sugimoto, Kazuyoshi Sigehara, Yoshifumi Kadono, Eitetsu Koh, and Mikio Namiki Hiroyuki KonakaHiroyuki Konaka Kanazawa, Japan More articles by this author , Kazuhiro SugimotoKazuhiro Sugimoto Kanazawa, Japan More articles by this author , Kazuyoshi SigeharaKazuyoshi Sigehara Kanazawa, Japan More articles by this author , Yoshifumi KadonoYoshifumi Kadono Kanazawa, Japan More articles by this author , Eitetsu KohEitetsu Koh Kanazawa, Japan More articles by this author , and Mikio NamikiMikio Namiki Kanazawa, Japan More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.2590AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Although several studies about the efficacy of androgen replacement therapy (ART) on late-onset hypogonadism (LOH) have been conducted in Western countries, most of which were small-scale and short-term studies. It is, however, still controversial whether ART can improve healthcare and prolong an active lifestyle. On the other hand, there have been no large-scale randomized controlled trials (RCT) regarding the efficacy of ART on LOH in Asian populations. We prospectively assessed the effects of long-term ART on physical and mental status in aging males with LOH in Japan. METHODS A total of 334 eligible patients over 50 years old with LOH were randomly assigned to either the ART group (n = 169) with intramuscular injection of methyltestosterone 250 mg each time every four weeks up to 12 times, or a control group (n = 165) without ART. In all participants, quality-of-life (QOL) questionnaires: Short Form-36 Health Survey (SF-36) and Aging Males Symptoms (AMS) score as a primary end point, and glycemic control, lipid parameters, waist circumference, body mass index (BMI), muscular strength, International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF)-5 scores, bone mineral density (BMD), and serum prostate-specific antigen (PSA) levels as secondary end points were evaluated 52 weeks after initiation of treatment. In addition, we examined whether long-term ART was safe and tolerable in these populations. RESULTS With regard to QOL, ART had a significant effect and a marginally significant influence on Role Physical subdomain (P = 0.0318) and Role Emotional subdomain (P = 0.0727) of the SF-36 scale, respectively. ART was associated with a significant decrease from baseline to 52 weeks in waist circumstance related to metabolic syndrome (P = 0.002) and serum TG (P = 0.013), and with significant increases in muscle mass volume of the whole body and legs (P = 0.071 and 0.0108, respectively), serum Hb (P < 0.001), in voiding subscore of IPSS (P = 0.0418), and the second question of IIEF-5 (P = 0.0049). There were no significant differences between the 2 groups in BMI, BMD, isometric handgrip strength, serum BS and HbA1c, serum PSA, or the incidence of severe adverse events. CONCLUSIONS Long-term ART not only improves androgen deficiency-associated symptoms, but also comprehensively improves psychological issues. Further studies are needed to examine the mental status in patients with LOH, and we hope our study will be beneficial in this area. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e506 Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Hiroyuki Konaka Kanazawa, Japan More articles by this author Kazuhiro Sugimoto Kanazawa, Japan More articles by this author Kazuyoshi Sigehara Kanazawa, Japan More articles by this author Yoshifumi Kadono Kanazawa, Japan More articles by this author Eitetsu Koh Kanazawa, Japan More articles by this author Mikio Namiki Kanazawa, Japan More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...