Testogel® (Testosterone Gel 50mg/5g) in the Treatment of Male Hypogonadism

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-center, Double Blind, Randomized, Placebo Controlled Study of Testogel® (Testosterone Gel 50mg/5g) in the Treatment of Male Hypogonadism

Conditions
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Hypogonadism

Intervention / Treatment
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* Drug: Testogel 1%
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male ages 18-68 years diagnosed as having testosterone deficiency with clinical symptoms A morning (8:00-10:00) serum Total Testosterone concentration of ≤ 300 ng/dL, confirmed by a second measurement of morning serum Total Testosterone concentration ≤ 300 ng/dL (samples to be taken 1 - 3 weeks apart) Exclusion Criteria: Abnormal prostate as evidenced by prostatic symptoms, prostatic masses or induration on rectal examination, or elevated levels of prostate specific antigen (PSA > 4ng/ml) or a maximum urine flow rate of less than 12 ml/sec(of a urine volume greater than 150ml) (and/or an International Prostate Symptom Score IPSS score >19) Hematocrit > 50% Major psychiatric illness Unable to understand the protocol or to give informed consent Use of paroxetine and clomipramine Active alcoholism History of drug abuse within the past five years; Use of drugs that might interfere with the results of the study (e.g., antiandrogen, estrogens or P 450 enzyme inducers, barbiturates); BMI < 18 or > 30 according to Chinese BMI references; Generalized skin disease that may affect absorption of T (e.g., psoriasis) or a known skin intolerance to alcohol; Prolactin > 40 mcg/L; Untreated severe obstructive sleep apnea;. Uncontrolled or poorly controlled heart failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testogel 1% 5g QD<br> | Drug: Testogel 1%<br> <br> |
| Placebo Comparator: Placebo gel 5g QD<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage 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 |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morning serum Total Testosterone (TT) concentration compared to placebo treatment |  | 3 months | 
| morning serum Total Testosterone (TT) concentration compared to baseline values |  | 3 months | 
| serum concentrations of TT, calculated free testosterone (cFT), DHT, E2, LH, and FSH, SHBG |  | 3 months | 
| prostate assessments (PSA, urine flow rate, DRE, ultrasound B) |  | 3 months | 
| skin integrity |  | 3 months |