The purpose of this study is to evaluate the safety and efficacy of Testogel® 50mg/5g gel administered once daily (QD, morning dosing) compared to placebo administered once daily (QD, morning dosing), for 3 months, in hypogonadal men with testosterone deficiency being confirmed by clinical features and biochemical tests. For men with hypogonadism, treatment aims to restore testosterone levels to normal physiological range.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
Peking University First Hospital
Beijing, China
RECRUITINGPercentage of patients with morning serum Total Testosterone concentration within the physiological range (300 - 1000 ng/dL or 10.4 - 34.7 nmol/L) after 3 months of Testogel treatment compared to placebo-treatment
Time frame: 3 months
morning serum Total Testosterone (TT) concentration compared to placebo treatment
Time frame: 3 months
morning serum Total Testosterone (TT) concentration compared to baseline values
Time frame: 3 months
serum concentrations of TT, calculated free testosterone (cFT), DHT, E2, LH, and FSH, SHBG
Time frame: 3 months
prostate assessments (PSA, urine flow rate, DRE, ultrasound B)
Time frame: 3 months
skin integrity
Time frame: 3 months
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