Testogel® (Testosterone Gel 50mg/5g) in the Treatment of Male Hypogonadism
Phase 3
- Conditions
- Hypogonadism
- Interventions
- Drug: Testogel 1%Drug: Placebo
- Registration Number
- NCT01786473
- Lead Sponsor
- Laboratoires Besins International
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 240
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Testogel 1% 5g QD Testogel 1% - Placebo gel 5g QD Placebo -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Peking University First Hospital
🇨🇳Peking, China