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Volume 18, Issue 1 (January 2016) 18, 25–34; 10.4103/1008-682X.148720

Effects of long-term androgen replacement therapy on the physical and mental statuses of aging males with late-onset hypogonadism: a multicenter randomized controlled trial in Japan (EARTH Study)

Hiroyuki Konaka1, Hirokazu Sugimoto1, Hideki Orikasa2, Teruaki Iwamoto3, Toshinari Takamura4, Yoshiyu Takeda5, Kazuyoshi Shigehara1, Masashi Iijima1, Eitetsu Koh1, Nikio Namiki1, the EARTH study group

1Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, Kanazawa, Ishikawa, Japan
2Division of Biostatistics and Clinical Epidemiology, University of Toyama School of Medicine, Toyama, Toyama, Japan
3Division of Male Infertility, Center for Infertility and IVF, international University of Health and Welfare, Nasushiobara, Tochigi, Japan
4Department of Disease Control and Homeostasis, Kanazawa University Graduate School of Medical Science, Kanazawa, Ishikawa, Japan
5Department of Internal Medicine, Division of Endocrinology and Hypertension, Kanazawa University Graduate School of Medical Science, Kanazawa, Ishikawa, Japan

Correspondence: Dr. H Konaka (h‑konaka@med.kanazawa‑u.ac.jp)



Androgen replacement therapy (ART) efficacy on late‑onset hypogonadism (LOH) has been widely investigated in Western countries; however, it remains controversial whether ART can improve health and prolong active lifestyles. We prospectively assessed long‑term ART effects on the physical and mental statuses of aging men with LOH in Japan. The primary endpoint was health‑related quality of life assessed by questionnaires. Secondary endpoints included glycemic control, lipid parameters, blood pressure, waist circumference, body composition, muscular strength, International Prostate Symptom Scores (IPSS), International Index of Erectile Function‑5 (IIEF‑5) scores, and serum prostate‑specific antigen levels. Of the 1637 eligible volunteers, 334 patients > 40 years with LOH were randomly assigned to either the ART (n = 169) or control groups (n = 165). Fifty‑two weeks after the initial treatment, ART significantly affected the role physical subdomain of the short form‑36 health survey (SF‑36) scale (P = 0.0318). ART was also associated with significant decreases in waist circumstance ( P = 0.002) and serum triglyceride (TG) ( P = 0.013) and with significant increases in whole‑body and leg muscle mass volumes ( P = 0.071 and 0.0108, respectively), serum hemoglobin (P < 0.001), IPSS voiding subscore (P =  0.0418), and the second question on IIEF‑5 ( P = 0.0049). There was no significant difference between the groups in terms of severe adverse events. In conclusion, in patients with LOH, long‑term ART exerted beneficial effects on Role Physical subdomain of the SF‑36 scale, serum TG, waist circumstance, muscle mass volume, voiding subscore of IPSS, and the second question of IIEF‑5. We hope our study will contribute to the future development of this area.

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