Hypogonadism
Conditions
Brief summary
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.
Interventions
DRUGTestogel 1%
DRUGPlacebo
Sponsors
Laboratoires Besins International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 68 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
China
Contacts
Primary ContactEllen Dhoore
Outcome results
None listed