Testogel® (Testosterone Gel 50mg/5g) in the Treatment of Male Hypogonadism
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ClinicalTrials.gov Identifier: NCT01786473
Recruitment Status : Unknown
Verified February 2013 by Laboratoires Besins International. Recruitment status was: Recruiting
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.
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 [ Time Frame: 3 months ]
Secondary Outcome Measures :
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 ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 68 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)
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
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;