Efficacy and safety of low dose testosterone ointment therapy for late-onset hypogonadism patients
Amano, T1; Iwamoto, T2; Sato, Y3; Matsumoto, Y1; Kishikage, T1; Imao, T1
1: Nagano Red Cross Hospital, Japan; 2: Center of Infertility IVF, International University of Health and Welfare, Japan; 3: Sanjukai Urological Hospital, Japan
Objectives: There are several testosterone replacement therapy (TRT) methods for late-onset hypogonadism (LOH), including oral, injection, trans-dermal, etc. However, only TRT with injection (testosterone enanthate) or short-acting ointment (Glowmin: GL) are available for LOH patients in Japan. Our previous report revealed that 3 mg of a short-acting testosterone ointment elevated serum testosterone levels within the physiological range for 4 to 6 hours. The aim of this study was to clarify clinical efficacy and safety of GL once every morning, which would enhance a circadian rhythm of testosterone.
Material and Methods: Each Institutional Review Board (IRB) approved this prospective clinical study and informed consents had been obtained from 61 LOH patients. These 61 LOH patients received 3 mg of GL once daily in the morning on scrotal skin and the clinical efficacy of GL were estimated by aging male symptoms (AMS) score at 4, 12 and 24 weeks after GL administration. Blood sampling tests including serum hormone levels, hemoglobin, liver and real functions, lipids, blood sugar and prostate specific antigen were compared before and 12, 24 weeks after GL treatment.
Results: Patients ages ranged from 40 to 81 years (mean 55.3 +/- 9.2). Total AMS scores before treatments were from 29 to 74 (mean 51.3 +/- 9.8). Total AMS scores at 4, 12 and 24 weeks after GL treatments significantly decreased to 42.7 +/- 11.6, 40.7 +/- 11.2 and 38.8 +/- 8.8, respectively. The results of sub-analysis of AMS, including psychological, physical and sexual factors also significantly improved after GL treatments. Blood sampling tests revealed that significantly elevated 1 hour after GL administration within physiological range. In addition, nadir serum total and free testosterone levels at just before GL application were maintained at 24 weeks after GL treatments. The other blood sampling tests including LH revealed no significant difference compared with base line results. No severe adverse reactions or abnormal laboratory data have reported.
Conclusions: According to our present data, low dose GL treatment supporting testosterone circadian rhythm is considered to be an effective and safe therapy for LOH.
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