Clinical trial NCT01786473: Testogel® (Testosterone Gel 50mg/5g) in the Treatment of Male Hypogonadism
Official title: A Multi-center, Double Blind, Randomized, Placebo Controlled Study of Testogel® (Testosterone Gel 50mg/5g) in the Treatment of Male Hypogonadism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypogonadism
Lead sponsor: Laboratoires Besins International
Sponsor class: INDUSTRY
First posted: 2013-02-08
Enrollment: 240
Sex: MALE
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 3 months
Secondary outcomes:
measure: morning serum Total Testosterone (TT) concentration compared to placebo treatment
timeFrame: 3 months
measure: morning serum Total Testosterone (TT) concentration compared to baseline values
timeFrame: 3 months
measure: serum concentrations of TT, calculated free testosterone (cFT), DHT, E2, LH, and FSH, SHBG
timeFrame: 3 months
measure: prostate assessments (PSA, urine flow rate, DRE, ultrasound B)
timeFrame: 3 months
measure: skin integrity
timeFrame: 3 months
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University First Hospital
Study officials:
affiliation: Peking University First Hospital
name: Jie Jin
role: PRINCIPAL_INVESTIGATOR
References: