The patients with late-onset hypogonadism and benign prostate hypertrophy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: The patients with LOH syndrome and BPH can be enrolled in this study. 1) serum testosterone<11.8 pg/ml (The criteria of LOH syndrome) 2) the patients with PSA<4.0ng/ml or the ones with PSA>=4.0ng/ml who are unlikely to have prostate cancer clinically 3) ageg range 50 from 90 4) the patients who can be obtained informed consents before entry of this study 5) performance status; 0 to 2 6) GOT and GTP more than 1.5 times the upper limits of the normal range, and Cr more than 2.0 times the upper limits of the normal range 7) the patients without any complications to treatimmdiately at the hospitalization
Exclusion criteria
Exclusion criteria: 1) prior usages of another anti-androgen drug 2) prior useage of finasteride 3) the patients with prostate cancer 4) the patients who have difficulty in receiving any checks or examinations according to the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the clinical effects of dutasteride administration on glucose, lipid and muscle metabolism | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effects as follwing: 1) Voiding symptoms for BPH 2) Prostate volume 3) Prostate specific antigen level 4) Bone mineral density 5) Erectile function 6) adverse effects | — |
Countries
Japan