New androgen replacement therapy trials in Japan

Abstract

Introduction Androgen replacement therapy (ART) has been applied to alleviate the various symptoms of late onset hypogonadism (LOH) patients. Japanese andrologists typically administer only testosterone enanthate injection, as newer testosterone agents are not permitted for current clinical use under Japanese regulations. Under these difficult circumstances, we discovered a testosterone ointment OTC (over the counter) and this ointment (Glowmin (GL): Daito Pharmaceutical Co. Ltd., Tokyo) contains 100mg of testosterone per 10g of matrix (1%). Methods Firstly, the profiles of serum total testosterone (TT) and free testosterone (FT) levels were assessed after application of 3mg of GL to scrotal skin. Secondly, the clinical effects of GL in the LOH patients were estimated by the Aging Male Symptom (AMS) scale. Medical Outcomes Study, 36-item Short-Form Health Survey (SF-36) and International Index of Erectile Function (IIEF 5) questionnaire after 12 weeks of GL treatment. Thirdly, International Prostate Symptom Score (IPSS) and its sub-scores (post-voiding, storage, voiding symptoms and quality of care or QOL) were also analyzed before and after ART. Results GL is a short-acting testosterone ointment capable of slight elevation of TT and FT. The clinical effects of G L observed in LOH patients include mental factor, physical factors and sexual function factor in AMS, erectile dysfunction in IIEF 5, and Role Physical, Social Functioning, Role Emotional and Mental Health in the SF-36 questionnaire. Total IPSS improved significantly after 3 months of ART and voiding disturbance have improved more than storage. Conclusions ART by GL is effective in the improvement of not only LOH symptoms, but also lower urinary tract symptoms (LUTS).