Late Onset Hypogonadism
Conditions
Interventions
1:Testosterone Undecanoate Capsule
2:Placebo
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
Male
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: Subjects were men at least 50 years of age with symptoms of androgen deficiency which was indicated by a positive score on androgen deficiency in aging males (ADAM) questionnaire as well as total morning testosterone measurement of <8nmol/L (230ng/dL), or free testosterone level <225pmol/L (65pg/mL) if the serum total testosterone level is between 8 and 12nmol/L
Exclusion criteria
Exclusion criteria: History or present diagnosis of breast or prostate cancer; any clinically significant abnormal finding on physical examination including the prostate; lower urinary tract symptoms (LUTS; IPSS>14); a prostate specific antigen (PSA) level >4ng/ml at screening; cause of androgen deficiency other than aging; treatment with androgens or anabolic steroids within the last two years; hyperprolactinemia or treatment with prolactin-lowering drugs; history of known chronic polycythemia and/or hematocrit >50% at screening; history or presence of severe sleep apnea; uncontrolled hypertension; diabetes mellitus; any clinically significant abnormal hematological or biochemical values or physical finding; unstable or untreated endocrine disorders; liver or renal diseases; psychiatric diseases; confirmed hypothalamic diseases; corticosteroid intake; history or presence of other disorders such as clinically significant cardiovascular, cerebrovascular or hematological disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SF-12; | — |
Countries
China
Contacts
Public ContactZhang Xiaowei
Outcome results
None listed