None listed
Conditions
Interventions
None listed
Sponsors
Chonbuk National University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1). The study population is comprised of hypogonadal patients who visit to the Chonbuk National University Hospital and has testosterone deficiency syndrome and has 18 to 80 years old of age. 2). On screening, the patient who has lower total testosterone level less than 2.5 ng/ml. 3). On screening, the patient who has lower level less than 18 g/dl of hemoglobin. 4). On screening, the patient who has lower level less than 52% of hematocrit. 5). The patient agree to the study after the patient listen the explanation about the study. 6). In androgen deficiency in the aging male (ADAM) questionnaire, the patient who has positive answer to the question about sexual dysfunction, or has positive answer to other 2 questionnaires.
Exclusion criteria
Exclusion criteria: 1). The patient who has not treated for specific disease for 5 years. 2). The patient who has been administered androgen for recent 3 months. 3). The patient who has treated with antiandrogen in recent 3 months. 4). The patient who has the abnormal laboratory data; AST and ALT are over 2 times more than upper limit of normal range Serum creatinine is over more than 2.0 mg/dl Creatine Kinase is over 2 times more than upper limit of normal range. 5). The patient who was administered corticosteroid in recent 3 months. 6). The patient who was transfused whole blood or constituent donation in recent 3 months. 7). The patient who drink severe amount of alcohol over 21 units/week 8). The patient who was join the other clinical trial 1 month before this clinical trial. 9). The patient who has prostate specific antigen (PSA) level more than 4 ng/ml (However, the patient who has not been identified to prostate cancer by the biopsy can be enrolled the study). 10). The patient who has prostate cancer 11). The patient who has severe benign prostate hyperplasia (BPH) (the volume is more than 60 ml and maximal uroflow rate is less than 5 ml/ sec.) 12). The patient who has abnormal laboratory data and is not good for the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of plasma testosterone levels | — |
Secondary
| Measure | Time frame |
|---|---|
| Free testosterone, CBC, biochemical analysis, blood viscosity, SPA, prostate volume,anemic factors | — |
Countries
Korea, Republic of
Contacts
Public ContactJong Kwan Park
Chonbuk National University Hospital
Outcome results
None listed